Diagnosing Dx
- Folgen
- 64
- Erscheint
- wöchentlich
- Letzte Folge
- 12. Nov. 2026
Über den Podcast
How do we transform cutting-edge scientific discoveries into life-saving diagnostics? On Diagnosing Dx, we explore the scientific innovation driving diagnostics forward, unpack industry challenges, and spotlight success stories. Join us as we speak with leading researchers and innovators at the forefront of Dx. Learn to: 🔹 Navigate industry challenges 🔹 Understand emerging science 🔹 Strategise for growth 🔹 Gain future-focused insight Essential listening for everyone involved in bringing new sciences to life in the Dx and Omics industry, Subscribe now!
Folgen 64
Why Does Better Diagnostic Science Struggle to Reach Patients? Hannah Mamuszka, Founder Alva10
In this episode of Diagnosing Dx, David Filby is joined by Hannah Mamuszka, Founder of Alva10.After more than 20 years in the diagnostics industry, Hannah has seen first-hand why promising scientific …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Hannah Mamuszka, Founder of Alva10.
After more than 20 years in the diagnostics industry, Hannah has seen first-hand why promising scientific breakthroughs don't always translate into better patient care. The challenge often isn't the science itself, but the financial incentives, reimbursement structures and clinical workflows that determine whether a diagnostic test is actually adopted.
Hannah explains how Alva10 approaches this problem from both sides, working with diagnostic developers and healthcare payers to identify unmet needs, understand the economics of care and create clearer routes to market.
We explore why better diagnostics can struggle to gain reimbursement, the growing influence of self-insured employers, opportunities in treatment-response prediction, and what founders need to understand before investing years in developing a test.
Key takeaways:
🔹 Why strong clinical evidence alone isn't enough to drive diagnostic adoption
🔹 How reimbursement and financial incentives can prevent better tests from reaching patients
🔹 Why Alva10 works backwards from payer needs to identify commercial opportunities for diagnostics
🔹 The growing opportunity for companion diagnostics and treatment-response prediction beyond oncology
🔹 Why founders must understand clinical workflows, healthcare economics and reimbursement much earlier in developmentChapters:
02:06 Hannah's background and journey through diagnostics
07:57 Why healthcare incentives can work against better diagnostics
09:08 Why Hannah founded Alva10
15:15 Working with payers and self-insured employers
17:22 Where the biggest diagnostic opportunities exist
25:34 How employers are driving demand for better testing
29:14 Why clinical workflow and healthcare economics matter
39:50 What needs to change for diagnostics to reach more patientsGuest: Hannah Mamuszka
Founder, Alva10
LinkedIn: https://www.linkedin.com/in/hannah-mamuszka-5121454/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Is AI About to Redefine What a Diagnostics Company Does? Sivan Bercovici, CTO & CBO - Karius
In this episode of Diagnosing Dx, David Filby is joined by Sivan Bercovici, Chief Technology Officer and Chief Business Officer at Karius.With more than two decades working at the intersection of computer …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Sivan Bercovici, Chief Technology Officer and Chief Business Officer at Karius.
With more than two decades working at the intersection of computer science, AI and medicine, Sivan has spent over a decade helping build Karius' computational capabilities. In this conversation, we explore how AI is moving diagnostics beyond simply delivering test results towards providing meaningful clinical intelligence.
Sivan explains how Karius has accumulated data from more than 150,000 cases, creating opportunities to identify patterns, improve diagnostic performance and help clinicians interpret increasingly complex information.
We also discuss the shift from molecular intelligence to clinical decision support, the risks of over-reliance on AI, and why some of the world's most underserved healthcare systems could ultimately be among the fastest to benefit from it.
Key takeaways:
🔹 Why the future of diagnostics could extend beyond reporting molecular results
🔹 How Karius is using data from 150,000 cases to advance diagnostic intelligence
🔹 Why AI should support clinical decisions rather than replace physician judgement
🔹 The challenges of regulation, reliability and systematic errors in medical AI
🔹 Why underserved healthcare systems could potentially leapfrog more established marketsChapters:
01:06 Introduction and Sivan Bercovici's background
03:01 The origins of Karius and infectious disease liquid biopsy
08:19 How AI in diagnostics has evolved
11:26 Molecular intelligence and improving diagnostic accuracy
15:01 Why access to 150,000 cases changes what's possible
19:45 Moving from molecular results to clinical intelligence
26:54 AI hype versus reality in healthcare
32:27 Regulation, ethics and the future of AI-driven careGuest: Sivan Bercovici, PhD
Chief Technology Officer & Chief Business Officer, Karius
LinkedIn: https://www.linkedin.com/in/sivanbercovici/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/Learn more about Karius: https://kariusdx.com/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Can AI Help Us Treat Cancer Without Overtreating Patients? Oliver Bathe, Qualisure Diagnostics
In this episode of Diagnosing Dx, David Filby is joined by Dr Oliver Bathe, Founder and CEO of Qualisure Diagnostics.After more than 25 years as a surgical oncologist, Oliver moved into diagnostics with a goal …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Dr Oliver Bathe, Founder and CEO of Qualisure Diagnostics.
After more than 25 years as a surgical oncologist, Oliver moved into diagnostics with a goal of helping clinicians make more precise treatment decisions. That work led to Thyroid GuidePx®, an 82-gene test designed to help identify whether papillary thyroid cancers are at higher or lower risk of recurrence.
But the bigger opportunity goes beyond a single test. Oliver explains how Qualisure developed Molecular deCodeR™, a cloud-based platform designed to help deploy machine-learning-powered molecular diagnostics across laboratories globally without requiring every test to be run in one central lab.
We also discuss decentralising precision oncology, building a transcriptomic foundation model, partnering with diagnostics and pharma companies, and why commercialisation has become the company’s next major focus.
Key takeaways:
🔹 Why many thyroid cancer patients may be treated more aggressively than necessary
🔹 How Thyroid GuidePx® helps assess recurrence risk in papillary thyroid cancer
🔹 Why centralised molecular testing can limit global access to precision oncology
🔹 How Molecular deCodeR™ could enable diagnostic companies to deploy tests across multiple labs and markets
🔹 Why Qualisure is building a foundation model to make transcriptomic diagnostics more reproducible across workflowsChapters:
01:06 Introduction and Oliver Bathe’s background
03:58 From cancer research to Qualisure Diagnostics
05:29 The overtreatment problem in thyroid cancer
08:26 Why precision oncology needs a decentralised model
11:01 Molecular deCodeR™ and the bigger software opportunity
13:18 Company milestones, partnerships and the $7M raise
19:07 Commercialising the platform globally
24:44 Building the next generation of transcriptomic diagnosticsGuest: Dr Oliver Bathe
Founder & CEO, Qualisure Diagnostics
Professor of Surgery and Oncology, University of Calgary
LinkedIn: https://ca.linkedin.com/in/oliver-bathe-76a84636Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could Genomic Testing Be as Accessible as a Smartphone? Ana Cornell, CEO & Founder of Acorn Genetics
In this episode of Diagnosing Dx, David Filby is joined by Ana Cornell, Founder and CEO of Acorn Genetics.Ana started Acorn after experiencing first-hand how expensive and inaccessible genomic testing could be …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Ana Cornell, Founder and CEO of Acorn Genetics.
Ana started Acorn after experiencing first-hand how expensive and inaccessible genomic testing could be. While studying biomedical engineering at Northwestern, she began developing lower-cost genomic analysis technology before being selected for the highly competitive Thiel Fellowship, which gave her the opportunity to leave university and build Acorn full-time.
The company’s long-term goal is to decentralise genomic analysis, bringing testing out of central laboratories and making it dramatically more accessible.
But the route to that goal hasn’t been conventional. When regulatory changes disrupted Acorn’s original clinical launch plans, the company pivoted its technology into brewing, agriculture and water testing, finding early product-market fit, generating revenue and continuing to develop its sequencing platform.
Ana shares why revenue has become central to Acorn’s strategy, how the company is approaching profitability, and why she still sees decentralised genomic analysis as the ultimate destination.
Key takeaways:
🔹 Why Ana started Acorn Genetics after struggling to access genomic testing herself
🔹 How Acorn is working to decentralise genomic analysis
🔹 Why a regulatory roadblock led the company into brewing, agriculture and water testing
🔹 How early revenue and customer feedback are helping fund the bigger sequencing vision
🔹 Why Ana believes genomic analysis could eventually cost just dollars, or even penniesChapters:
01:04 Introduction and Ana Cornell’s background
02:31 The personal problem that led to Acorn Genetics
07:14 From university research to the Thiel Fellowship
13:42 Building Acorn and finding product-market fit
18:20 Why agriculture became the route to early revenue
21:29 The long-term vision for decentralised genomics
25:00 Driving down the cost of genomic analysis
28:03 Revenue, profitability and the milestones aheadGuest: Ana Cornell
Founder & CEO, Acorn Genetics
LinkedIn: https://www.linkedin.com/in/ana-cornell-53103a138/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/Support Acorn Genetics
Acorn Genetics’ crowdfunding campaign is now open. Learn more and invest here:
https://www.startengine.com/offering/acorn-genetics🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could High Frequency Monitoring Transform Autoimmune Care? Kavya Swaminathan
In this episode of Diagnosing Dx, David Filby is joined by Kavya Swaminathan, PhD, Co-Founder and CEO of Kascaid.An immunologist and proteomics scientist by training, Kavya has spent her career studying immune …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Kavya Swaminathan, PhD, Co-Founder and CEO of Kascaid.
An immunologist and proteomics scientist by training, Kavya has spent her career studying immune dysregulation and biomarker discovery. That experience led to Kascaid and a fundamental question: can we understand chronic immune disease better by measuring what is happening far more frequently?
Kavya explains why the company is turning to interstitial fluid (ISF) as an alternative to traditional blood sampling, and how higher-frequency immune measurements could help clinicians understand treatment response, detect disease changes earlier and move away from today’s trial-and-error approach to care.
We also discuss Kascaid’s plans for at-home sampling, its longer-term ambition to build a longitudinal immune data layer, and how partnerships with patients and clinicians are shaping the product from the earliest stages.
Key takeaways:
🔹 Why chronic immune disease needs more frequent and actionable biomarker data
🔹 The limitations Kavya sees in conventional blood-based immune measurements
🔹 Why interstitial fluid could enable higher-frequency monitoring
🔹 How Kascaid is initially focusing on treatment response and disease progression
🔹 Why longitudinal immune data could eventually support earlier diagnosis and more precise treatmentChapters:
01:07 Introduction
02:43 Kavya’s journey from immunology to diagnostics
07:08 Kascaid and the chronic immune disease problem
10:39 Why interstitial fluid instead of traditional blood testing?
15:06 Monitoring treatment response more frequently
19:26 Building a longitudinal immune data layer
25:05 Company milestones, partnerships and early validation
32:40 FDA, reimbursement and the path to marketGuest: Kavya Swaminathan, PhD
Co-Founder & CEO, Kascaid
LinkedIn: https://www.linkedin.com/in/kavya-swaminathan/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could a 10-Minute Test Stop Unnecessary Antibiotic Prescribing? Paul Kase, CCO - Lumos Diagnostics
In this episode of Diagnosing Dx, David Filby is joined by Paul Kase, Chief Commercial Officer at Lumos Diagnostics.Paul brings 30 years of healthcare experience, including more than 20 years in rapid …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Paul Kase, Chief Commercial Officer at Lumos Diagnostics.
Paul brings 30 years of healthcare experience, including more than 20 years in rapid point-of-care diagnostics. His history with FebriDx stretches back to its earliest development, and he now leads commercialisation as Lumos enters a major new phase following its US CLIA waiver.
Paul explains how FebriDx uses two host-response biomarkers to help differentiate bacterial from non-bacterial infections from a finger-stick blood sample in around 10 minutes, without instrumentation.
We also discuss antibiotic stewardship, reimbursement, integrating novel tests into existing clinical workflows, and the commercial strategy Lumos is using to drive adoption across urgent care and primary care.
Key takeaways:
🔹 Why the CLIA waiver represents such an important commercial milestone for FebriDx
🔹 How CRP and MxA are used to differentiate bacterial from non-bacterial infection
🔹 Why overlapping respiratory symptoms can contribute to unnecessary antibiotic prescribing
🔹 The three pillars Paul believes every novel point-of-care diagnostic needs to address
🔹 How Lumos is approaching reimbursement, distribution and adoption in the USChapters:
01:07 Introduction and Paul Kase’s background
05:43 Lumos Diagnostics and the FebriDx CLIA waiver
08:03 How FebriDx works and the unmet need
09:54 Changing the respiratory testing workflow
14:27 Clinical utility, workflow and reimbursement
20:21 Commercialisation, adoption and distribution
25:14 International expansion and future markets
30:53 Future milestones and driving commercial growthGuest: Paul Kase
Chief Commercial Officer, Lumos Diagnostics
LinkedIn: https://www.linkedin.com/in/paul-kase-8bb96159/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Will Payer-Dependent Diagnostics Companies Get Left Behind? Marty Keiser, Founder at IVBH / Mammogen
In this episode of Diagnosing Dx, David Filby is joined by Marty Keiser, Founder and CEO of IVBH. After beginning his career in asset management and capital markets, Marty moved into biotech eight years ago …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Marty Keiser, Founder and CEO of IVBH.
After beginning his career in asset management and capital markets, Marty moved into biotech eight years ago with a focus on blood-based molecular diagnostics and early disease detection. That outside perspective shaped how he built IVBH, borrowing ideas from industries beyond diagnostics to create a different model for developing and scaling diagnostic companies.
Marty explains IVBH’s studio model, the science behind its cell-free RNA platform, and how its health franchises are developing tests across breast cancer, lung cancer and metabolic liver disease.
We also discuss why traditional diagnostics business models can struggle, the growing opportunity for cash-pay and consumerised testing, and what helped Mammogen secure institutional Series A funding in a difficult market.
Key takeaways:
🔹 Why Marty believes the traditional diagnostics business model needs to evolve
🔹 How IVBH uses a central discovery platform to build multiple health franchises
🔹 Why cell-free RNA could offer advantages for earlier disease detection
🔹 How LDTs, cash-pay models and new diagnostic “storefronts” could reshape commercialisation
🔹 What investors looked for when Mammogen raised its Series AChapters:
01:02 Introduction and Marty Keiser’s background
03:22 Moving from capital markets into diagnostics
08:20 Building the IVBH business model differently
11:27 Surviving the biotech downturn and changing capital markets
16:09 The science behind IVBH’s cell-free RNA platform
20:06 LDTs, cash-pay testing and new commercial models
26:13 What helped Mammogen secure its Series A
30:26 Future milestones and rethinking diagnostics growthGuest: Marty Keiser
Founder & CEO, IVBH
LinkedIn: https://www.linkedin.com/in/martykeiserHost: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
What If the Patients Who Need Your Test Are Already Hiding in the EHR? Sagacity Diagnostics
In this episode of Diagnosing Dx, David Filby is joined by Raymond Tarr, Founder of Sagacity Diagnostics.Raymond brings more than 25 years of experience across diagnostics, rare disease, commercialisation and …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Raymond Tarr, Founder of Sagacity Diagnostics.
Raymond brings more than 25 years of experience across diagnostics, rare disease, commercialisation and patient finding, with previous roles spanning companies including Cepheid and AstraZeneca/Alexion. His experience in rare disease, both professionally and personally, ultimately led to the creation of Sagacity Diagnostics and its PathfindEHR platform.
Raymond explains how PathfindEHR is designed to help clinicians identify patients who may be undiagnosed, misdiagnosed or missing the right testing by making better use of data already sitting within electronic health records.
We also discuss the adoption challenge facing diagnostics companies, how better workflow integration could drive more appropriate testing, and why education and awareness can be just as important as developing the test itself.
Key takeaways:
🔹 Why existing EHR data could help shorten the diagnostic journey
🔹 How PathfindEHR helps identify suspect and potentially misdiagnosed patients
🔹 Why better workflow integration can increase appropriate diagnostic testing
🔹 How diagnostics companies can benefit from stronger clinician education and adoption tools
🔹 Why rare disease is only the starting point for Sagacity’s wider ambitionsChapters:
00:59 Introduction and Raymond Tarr’s background
05:46 Moving from diagnostics into rare disease
08:57 The personal experience behind Sagacity Diagnostics
11:00 How PathfindEHR works
17:49 Using EHR data to identify patients who need testing
23:16 How diagnostics companies can benefit from the platform
29:16 Commercialisation and early market traction
34:40 Future milestones and scaling SagacityGuest: Raymond Tarr
Founder, Sagacity Diagnostics
LinkedIn: https://www.linkedin.com/in/raymondtarr/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Can Strategic Partnerships Save Diagnostics Innovation? Robert Carlson
In this episode of Diagnosing Dx, David Filby is joined by Robert Carlson, Founder and President of Life Science Dx Consulting.Robert brings 30 years of experience across diagnostics and life sciences, spanning …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Robert Carlson, Founder and President of Life Science Dx Consulting.
Robert brings 30 years of experience across diagnostics and life sciences, spanning scientific, commercial, corporate development and executive leadership roles.
He explains why early-stage diagnostics companies should think about partnerships much earlier, not only as a source of funding but as a way to build credibility, strengthen commercial strategy and create new routes to market.
The conversation also covers reimbursement, market access, investor expectations and why strong science alone is rarely enough to build a successful diagnostics company.
Key takeaways:
🔹 Why diagnostics founders should consider partnerships before they urgently need them
🔹 How strategic partnerships can strengthen a future fundraising story
🔹 Why fear around IP, dilution and losing control can hold founders back
🔹 The importance of understanding reimbursement and market access early
🔹 Why commercial strategy should develop alongside the scienceChapters:
00:56 Introduction and Robert Carlson’s background
05:40 Why partnerships matter in early-stage diagnostics
12:19 Using partnerships to strengthen fundraising
14:51 Why founders hesitate to partner early
19:29 IP, control and the fear of being locked in
25:29 Why great science alone isn’t enough
28:43 Reimbursement, regulatory strategy and investor expectations
35:18 Building the right commercial strategy from the startGuest: Robert Carlson
Founder and President, Life Science Dx Consulting
LinkedIn: https://www.linkedin.com/in/robertwcarlsonsr/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could More Frequent Blood Testing Transform How We Detect Disease?
In this episode of Diagnosing Dx, David Filby is joined by Octavian Florescu, CEO of In Diagnostics.An electrical engineer and microchip designer by training, Octavian has spent his career exploring how …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Octavian Florescu, CEO of In Diagnostics.
An electrical engineer and microchip designer by training, Octavian has spent his career exploring how semiconductor technology can be applied to blood testing. After building and exiting his first diagnostics company, he took those lessons into In Diagnostics alongside his co-founder and wife, Ana.
Octavian explains how the company is developing microchip-based blood testing from a drop of blood, why they are launching first in the veterinary market, and how a two-person “minimum viable company” is working towards profitability before expanding further into human diagnostics.
We also discuss what founders learn when capital is scarce, why diagnostics may need different funding models, and how better access to longitudinal blood data could support more personalised healthcare.
Key takeaways:
🔹 Why Octavian believes blood testing should become more frequent and accessible
🔹 How lessons from his first diagnostics company shaped In Diagnostics
🔹 Why the veterinary market offers an early route to revenue and product validation
🔹 The thinking behind building a two-person “minimum viable company”
🔹 Why diagnostics funding may need to move beyond traditional venture timelinesChapters:
01:02 Introduction and Octavian Florescu’s background
04:32 From microchip design to blood testing
06:33 Lessons from his first diagnostics company
11:20 Building In Diagnostics as a minimum viable company
13:52 Microchip-based blood testing and the unmet need for more data
19:15 Launching first in veterinary diagnostics
22:27 Building towards profitability without traditional VC funding
29:53 Upcoming milestones and the future of diagnosticsGuest: Octavian Florescu
CEO, In Diagnostics
LinkedIn: https://www.linkedin.com/in/octavian-florescu-51b28817/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Why Are Vector-Borne Infections Still So Difficult to Diagnose?
In this episode of Diagnosing Dx, David Filby is joined by Nicole Bell, CEO of Galaxy Diagnostics.Nicole’s route into vector-borne disease diagnostics is deeply personal. After her husband was initially …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Nicole Bell, CEO of Galaxy Diagnostics.
Nicole’s route into vector-borne disease diagnostics is deeply personal. After her husband was initially diagnosed with early-onset Alzheimer’s disease, she continued searching for answers and later discovered he had Lyme disease alongside Babesia and Bartonella infections.
That experience led Nicole to Galaxy Diagnostics, where the company is working to improve direct detection of vector-borne infections using approaches including urine antigen testing and high-sensitivity PCR.
Nicole discusses why these infections are so difficult to diagnose, how outdated and antibody-based testing can leave patients without clear answers, and Galaxy’s plans to take its Lyme urine antigen test through clinical studies towards FDA submission.
Key takeaways:
🔹 Why Lyme, Bartonella and Babesia can be particularly difficult to detect
🔹 The limitations of relying on antibody testing for active infection
🔹 Why vector-borne disease exposure extends far beyond obvious tick bites
🔹 How Galaxy Diagnostics is approaching direct pathogen detection
🔹 The company’s path towards FDA approval, reimbursement and broader adoptionChapters:
00:57 Introduction and Nicole Bell’s background
02:43 The personal story behind Nicole’s move into vector-borne diagnostics
08:17 Why vector-borne infections are so difficult to diagnose
13:28 Galaxy Diagnostics and its direct detection approach
17:22 How widespread is the vector-borne disease problem?
22:05 Commercialisation, clinical studies and the path to FDA approval
27:13 Raising a Series A in a difficult diagnostics market
31:31 Upcoming milestones and the future of diagnosticsGuest: Nicole Bell
CEO, Galaxy Diagnostics
LinkedIn: https://www.linkedin.com/in/nicoledaniellebell/Learn more about Galaxy Diagnostics: https://www.galaxydx.com/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
What Can Diagnostics Founders Learn From Two Successful Exits? Andrew Miller
In this episode of Diagnosing Dx, David Filby is joined by Andrew Miller, a diagnostics founder, advisor and two-time exited CEO.A scientist by training, Andrew founded and led companies focused on rapid …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Andrew Miller, a diagnostics founder, advisor and two-time exited CEO.
A scientist by training, Andrew founded and led companies focused on rapid molecular diagnostics, taking Ionian Technologies through acquisition by Alere and later building NAT Diagnostics, which was acquired by Becton Dickinson in 2020. The technology developed at Ionian ultimately became central to Abbott’s ID NOW platform.
Andrew shares what he learned from going through the acquisition process twice, why his second company was designed for sale from the outset, and the four risks he believes every diagnostics founder needs to manage: technology, operations, finance and commercial relevance.
Key takeaways:
🔹 What Andrew learned from two successful diagnostics exits
🔹 Why Ionian chose acquisition rather than funding the full journey to FDA approval
🔹 How the lessons from his first exit shaped NAT Diagnostics from day one
🔹 Why founders need to prepare for due diligence long before an acquisition process begins
🔹 The four risks Andrew uses to assess early-stage diagnostics companiesChapters:
00:00 Introduction and Andrew Miller’s background
02:23 Two diagnostics exits and the opportunity in rapid molecular testing
04:03 Building Ionian Technologies
08:37 Why Ionian pursued an acquisition
15:00 Building NAT Diagnostics differently the second time
19:04 Designing a diagnostics company for acquisition
27:03 Advising founders and the four risks every startup faces
31:33 Where diagnostics is heading nextGuest: Andrew Miller, PhD
Diagnostics Founder, Advisor & Two-Time Exited CEO
LinkedIn: https://www.linkedin.com/in/andrew-miller-2670811/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
98% of Cancer Patients Outside the US Miss Genomic Testing. Can AI Change That?
In this episode of Diagnosing Dx, David Filby is joined by Travis Wold, Chief Executive Officer at Imagenomix.Travis brings experience across cancer diagnostics, genomics, liquid biopsy, and international …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Travis Wold, Chief Executive Officer at Imagenomix.
Travis brings experience across cancer diagnostics, genomics, liquid biopsy, and international commercialization. We explore how Imagenomix is using AI to help make genomic testing more accessible to cancer patients globally.
With around 98% of cancer patients outside the US not receiving NGS testing, Travis explains how analysing standard H&E pathology images could help identify patients who are more likely to benefit from confirmatory genomic testing.
We also discuss Imagenomix’s commercial strategy, digital pathology partnerships, and the longer-term potential for AI to support more precise treatment decisions in oncology.
Key takeaways:
🔹 Why access to genomic testing remains extremely limited outside the US
🔹 How Imagenomix uses AI to identify mutation signals from standard H&E pathology images
🔹 Why AI screening could reduce the cost and volume of unnecessary NGS testing
🔹 How digital pathology partnerships could help Imagenomix scale globally
🔹 Why predicting treatment response could become the next major step for AI in precision oncologyChapters:
00:59 Introduction and Travis Wold’s background
05:29 From cancer diagnostics to the global genomic testing problem
09:42 The limitations of NGS and where AI fits into the workflow
13:36 Imagenomix’s mission and the 98% genomic testing gap
17:42 Funding, digital pathology partnerships, and commercial traction
20:36 Regulatory strategy, screening, and the path towards companion diagnostics
23:13 Can AI predict which cancer patients will respond to treatment?
32:56 Scaling Imagenomix globally and the milestones aheadGuest: Travis Wold
Chief Executive Officer at ImagenomixLinkedIn: https://www.linkedin.com/in/travisjwold/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could 20-Minute Hormone Testing Transform Patient Care? Nedal Safwat, SVP at Canatu
In this episode of Diagnosing Dx, David Filby is joined by Nedal Safwat, Senior Vice President of Medical Diagnostics at Canatu and President of Canatu Inc.With more than 20 years in diagnostics, Nedal has held …
Shownotes
In this episode of Diagnosing Dx, David Filby is joined by Nedal Safwat, Senior Vice President of Medical Diagnostics at Canatu and President of Canatu Inc.
With more than 20 years in diagnostics, Nedal has held leadership roles across Cepheid, QIAGEN, bioMérieux and Luminex. He now leads Canatu’s expansion into medical diagnostics, taking the company’s carbon nanotube technology into point-of-care testing.
Nedal explains why Canatu has chosen hormone testing and sepsis as its first areas of focus, and why the company started with the unmet clinical need rather than trying to find an application for its technology.
We also discuss the opportunity for faster hormone testing, the shift towards decentralised diagnostics, reimbursement and design-to-cost, and how Canatu is combining the speed of a startup with the infrastructure and backing of an established company.
Key takeaways:
🔹 Why Canatu is bringing carbon nanotube technology into medical diagnostics
🔹 Why hormone testing and sepsis were selected as the company’s first focus areas
🔹 Why diagnostics companies should start with the unmet need and work backwards
🔹 How point-of-care hormone testing could improve convenience and reduce patient drop-off
🔹 Why reimbursement, cost and customer validation need to be considered from the beginningChapters:
00:53 Introduction and Nedal Safwat’s background
07:18 Canatu and the move into medical diagnostics
13:02 Why hormone testing and sepsis?
17:26 Starting with the unmet need and product-market fit
21:29 Partnerships, personalised hormone testing and patient demand
27:52 Product development and the path to commercialisation
32:57 Reimbursement, design-to-cost and startup culture
40:30 Future milestones and the diagnostics market outlookGuest: Nedal Safwat
Senior Vice President, Medical Diagnostics at Canatu
President, Canatu Inc.LinkedIn: https://www.linkedin.com/in/nedal-safwat/
Learn more about Canatu, Medical Diagnostics here: https://canatu.com/products/medical-diagnostics/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Could a $127M Seed Round Change Women's Health Forever? - Dean Remy, Co-Founder @ Mativa Dx
In this episode of Diagnosing Dx, David Filby is joined by Dean Remy, Co-Founder and Chief Commercial Officer at Mativa Diagnostics.Dean brings 35 years of experience across diagnostics, biotechnology, and …
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In this episode of Diagnosing Dx, David Filby is joined by Dean Remy, Co-Founder and Chief Commercial Officer at Mativa Diagnostics.
Dean brings 35 years of experience across diagnostics, biotechnology, and therapeutics. He explains why pregnancy testing has barely changed in 50 years and how the traditional positive-or-negative result can leave women without critical information during the earliest weeks of pregnancy.
Mativa is developing a reusable handheld device combining multiplex biomarker testing, graphene nanosensor technology, an AI-enabled app, and immediate care navigation. The company is also building a large longitudinal maternal biorepository to support future diagnostics, biomarker discovery, and therapeutic development.
This is a practical conversation about maternal health innovation, consumer access, partnerships, regulation, data, and building a platform designed to support women throughout the pregnancy journey.
Key takeaways:
🔹 Why the traditional pregnancy test does not provide women with enough early information
🔹 How Mativa plans to identify risks such as ectopic pregnancy and pre-eclampsia
🔹 Why a longitudinal maternal biorepository could transform diagnostics and therapeutic development
🔹 How retail, healthcare, pharmaceutical, and diagnostic partnerships could accelerate adoption
🔹 Why supporting the complete patient journey could define the next generation of diagnosticsChapters:
01:08 Introduction and Dean Remy’s background
03:24 Why maternal health urgently needs innovation
06:28 Mativa’s approach and the technology behind the platform
11:42 Building a comprehensive maternal biorepository
14:24 Commercial strategy and market positioning
17:13 Regulatory and reimbursement pathways
20:18 Capital raising and strategic partnerships
25:34 The future of Mativa and maternal diagnosticsGuest: Dean Remy
Co-Founder and Chief Commercial Officer at Mativa Diagnostics
LinkedIn: https://www.linkedin.com/in/scisourceremy/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Red Drop’s Bet on Pain-Free Blood Collection and the Next Wave of Diagnostics
In this episode of Diagnosing Dx, David Filby is joined by Thomas Briggs, Chief Growth Officer at RedDrop Dx.Thomas brings more than 25 years of diagnostics and healthcare growth experience, spanning pharma …
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In this episode of Diagnosing Dx, David Filby is joined by Thomas Briggs, Chief Growth Officer at RedDrop Dx.
Thomas brings more than 25 years of diagnostics and healthcare growth experience, spanning pharma, big diagnostics, medtech, and startup environments. In this conversation, we explore one of the most overlooked parts of diagnostics: blood collection, and why the process still looks far too similar to what it did decades ago.
Thomas breaks down where arm-based micro-sampling could genuinely change patient experience, from paediatrics and neurodivergent patients to home testing, clinical trials, and difficult vein access.We also get into the commercial reality behind a product like this: where the most promising markets are, why education still matters, how labs and platforms need to adapt, and what it takes to build a medtech business without following the usual VC-heavy playbook.
This is a practical conversation about workflow, access, patient experience, and what happens when a simple shift in blood collection could unlock broader changes across diagnostics and healthcare delivery.
Key takeaways:
🔹 Why blood collection remains one of the least-innovated parts of diagnostics
🔹 Where arm-based micro-sampling could have the biggest clinical and commercial impact
🔹 Why paediatrics, neurodivergent patients, and difficult vein access are such important use cases
🔹 How home sampling could change clinical trials, routine monitoring, and direct-to-consumer care
🔹 What it takes to commercialise a medtech product in both consumer and managed-care settings
Chapters:
01:51 Thomas Briggs’ background in diagnostics, pharma, and medtech
06:28 Moving from big corporates into startups
11:04 What RedDrop Dx is building and how the device works
14:39 Where the biggest commercial opportunities are for arm-based micro-sampling
18:48 Why education and awareness are still a major challenge
21:22 RedDrop Dx’s story so far and why it was bootstrapped
26:05 How the company is building for growth across different market segments
30:10 Future milestones, home collection clearance, and expansion into Europe
31:31 Thomas’s outlook on diagnostics, home testing, and micro-sampling in 2026
Guest: Thomas Briggs
Chief Growth Officer at RedDrop Dx
LinkedIn: https://www.linkedin.com/in/thomas-briggs-959865177/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.Why Cancer Patients Still Die From Infections We Can't Diagnose - Karius
In this episode of Diagnosing Dx, David Filby is joined by Alec Ford, Chief Executive Officer at Karius.Alec brings decades of leadership experience across therapeutics, vaccines, and genomics. In this …
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In this episode of Diagnosing Dx, David Filby is joined by Alec Ford, Chief Executive Officer at Karius.
Alec brings decades of leadership experience across therapeutics, vaccines, and genomics. In this conversation, we explore how Karius is bringing genomics into infectious disease and why the company has focused so sharply on immunocompromised patients.
The scale of the unmet need is staggering. Alec explains that 52% of cancer deaths in the US are due to infection rather than the underlying malignancy, rising to more than 60% in hematologic malignancies. He also shares that there are around 4 million hospital admissions for infection among cancer patients in the US each year, yet the standard hospital workup can still fail to identify the cause in far too many cases.
We also discuss the company’s growth, physician adoption, and why outpatient infectious disease testing could become a major next step.
This is a practical conversation about infectious disease diagnostics, commercialization, and building in one of the most important unmet areas in healthcare.
Key takeaways:
🔹 Why infectious disease remains one of the biggest threats to immunocompromised patients
🔹 How Karius is using microbial cell-free DNA to diagnose infection from a simple blood draw
🔹 Why focus and disciplined market selection have been central to Karius’ growth
🔹 How physician confidence and education shape adoption of new diagnostics
🔹 Why outpatient infectious disease testing could become a major next step for the fieldChapters:
01:00 Introduction and Alec Ford’s background
04:20 Transition from therapeutics to genomics
08:34 The founding story of Karius and how the technology works
14:52 Why Karius focused on immunocompromised patients
19:41 Scaling the company and driving adoption
27:20 Reimbursement, capital strategy, and path to profitability
34:40 The outpatient opportunity and Karius’ next chapter
45:03 Alec’s view on the diagnostics industry and what needs to changeGuest: Alec Ford
Chief Executive Officer at Karius
LinkedIn: https://www.linkedin.com/in/alec-ford-b578003/Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/Learn more about Karius here: https://kariusdx.com/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Can AI Rescue Cancer Drugs That Clinical Trials Say Have Failed?
In this episode of Diagnosing Dx, David Filby is joined by Alexander Bagaev, Chief Product Officer at BostonGene.Alexander has spent more than a decade helping build BostonGene from an early-stage team into a …
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In this episode of Diagnosing Dx, David Filby is joined by Alexander Bagaev, Chief Product Officer at BostonGene.
Alexander has spent more than a decade helping build BostonGene from an early-stage team into a global precision medicine company. In this conversation, we explore why oncology is moving beyond single biomarkers and how BostonGene has expanded from diagnostics into AI-powered treatment selection and clinical trial support.
We also discuss the challenge of bringing more comprehensive diagnostics into routine use, the role of multimodal data in better decision-making, and how BostonGene is working with pharma to design smarter trials from the outset.
This is a practical conversation about precision oncology, multimodal diagnostics, AI in drug development, and turning complex biology into clinically useful decisions.
Key takeaways:
🔹 Why single-gene and narrow-panel testing often misses the full picture in oncology
🔹 How BostonGene is combining genomics, transcriptomics, and immune profiling to improve treatment selection
🔹 Why reimbursement still lags behind the scientific need for integrated diagnostics
🔹 How multimodal AI and foundation models could reshape drug development and clinical trial design
🔹 What precision medicine companies need to understand about flexibility, regulation, and real-world adoptionChapters:
00:00 Introduction to Alexander Bagaev
03:25 Journey from physics to immunology
05:07 The evolution of BostonGene
07:55 Precision medicine and patient-centric treatment selection
10:28 Challenges in drug development and clinical trials
13:02 Growth and milestones of BostonGene
15:19 Navigating diagnostics and the role of AI
20:48 Future opportunities and advice for early-stage companiesGuest: Alexander Bagaev
Chief Product Officer at BostonGeneLinkedIn: https://www.linkedin.com/in/alexander-bagaev-5548166b/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
What If We Could Test Depression Drugs Before Patients Take Them? Dr Talia Cohen Solal - NeuroKaire
In this episode of Diagnosing Dx, David Filby is joined by Talia Cohen Solal, CEO at NeuroKaire.Talia is a neuroscientist by training who spent more than a decade in academia, including time at Oxford, UCL, and …
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In this episode of Diagnosing Dx, David Filby is joined by Talia Cohen Solal, CEO at NeuroKaire.
Talia is a neuroscientist by training who spent more than a decade in academia, including time at Oxford, UCL, and Columbia, before moving into the startup world to get closer to real patient impact. In this conversation, we explore why precision medicine has transformed fields like oncology but still has so far to go in psychiatry, and how NeuroKaire is trying to change that.
We discuss the limits of current antidepressant prescribing and how NeuroKaire is using patient-derived neurons to predict which treatments are most likely to work for each individual.
This is a practical conversation about precision psychiatry, commercialization, clinical evidence, and what it takes to bring better mental health diagnostics into real patient care.
Key takeaways:
🔹 Why psychiatry still lacks the precision medicine approach seen in other fields
🔹 How NeuroKaire is using patient-derived neurons to guide antidepressant treatment
🔹 Why clinical trials and guideline change are essential for real adoption
🔹 How the company is balancing commercial growth with platform expansion and pharma partnerships
🔹 What the future could look like for diagnostics in depression, anxiety, ADHD, and beyondGuest: Talia Cohen Solal
CEO at NeuroKaireLinkedIn: https://www.linkedin.com/in/talia-cohen-solal-5b49a78/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:
00:00 Introduction to Talia Cohen Solal and her background
08:23 Transitioning from academia to startups
09:52 The vision behind NeuroKaire and precision psychiatry
12:38 Clinical trials and validation of NeuroKaire’s technology
14:37 Commercialization, distribution, and reimbursement
16:46 Education and awareness in the medical community
19:44 Future growth, market potential, and new indications
26:47 Outlook on diagnostics and the future of neurodiagnostics🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Why AI Multiomics Will Replace Ultrasound in Liver Cancer Screening with Bharat Tewarie
In this episode of Diagnosing Dx, David Filby is joined by Bharat Tewarie, MD, MBA, CEO at Helio Genomics. Bharat has led Helio Genomics since July 2025, bringing decades of global healthcare leadership across …
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In this episode of Diagnosing Dx, David Filby is joined by Bharat Tewarie, MD, MBA, CEO at Helio Genomics.
Bharat has led Helio Genomics since July 2025, bringing decades of global healthcare leadership across pharma, biotech, diagnostics, and digital health. In this conversation, we explore why liver cancer surveillance still relies too heavily on outdated imaging, why so many high-risk patients fall through the cracks, and how Helio Genomics is trying to change that with HelioLiver, its blood-based test designed to improve early detection.
We discuss the limitations of ultrasound in liver cancer screening, the promise of AI-powered multiomics, and why early detection only matters if patients can actually access it. Bharat also shares how his clinical and commercial background shapes Helio’s strategy, from workflow design and physician adoption to partnerships, awareness, and the infrastructure needed to move from scientific validation to real clinical impact.
This is a practical conversation about liver cancer, access, commercialization, and what it takes to turn better diagnostics into better outcomes.
Key takeaways:
🔹 Why liver cancer surveillance still leaves too many high-risk patients undetected
🔹 How AI-powered multiomics and HelioLiver could improve early liver cancer detection
🔹 Why access and workflow matter just as much as scientific performance
🔹 How partnerships can accelerate commercialization and patient reach
🔹 What Helio Genomics is building beyond HelioLiver as it expands its platform
Guest: Bharat Tewarie, MD, MBA
CEO at Helio Genomics
LinkedIn: https://www.linkedin.com/in/bharattewarie/
Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/
Chapters:
00:00 Introduction to Bharat Tewarie and Helio Genomics
01:42 Bharat’s journey from medicine to business
06:25 The evolution of diagnostics, omics, and AI
10:36 Helio Genomics’ mission and differentiators
12:03 Unmet needs in liver cancer surveillance
14:01 Awareness, access, and clinical workflow challenges
19:10 The role of partnerships in commercialization
26:27 Growth strategy and the future of diagnostics🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Start with Reimbursement and Work Backwards - Jonathan Romanowsky
In this episode of Diagnosing Dx, I’m joined by Jonathan Romanowsky, co-founder of Inflammatix and Principal at Kadima Spark.Jonathan shares lessons from leading diagnostics launches at CareDx, CardioDX …
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In this episode of Diagnosing Dx, I’m joined by Jonathan Romanowsky, co-founder of Inflammatix and Principal at Kadima Spark.Jonathan shares lessons from leading diagnostics launches at CareDx, CardioDX, Veracyte, and Inflammatix. We discuss commercialization, reimbursement, fundraising, and why startups need to think about market adoption much earlier than before.We also explore Inflammatix’s evolution into a full IVD company and the key factors that separate diagnostics companies that launch from those that successfully scale.Key takeaways:🔹 Why reimbursement strategy needs to shape diagnostics planning from the start🔹 What makes a launch succeed beyond strong science and clinical validation🔹 Why early-stage companies now need commercial credibility much sooner🔹 How Inflammatix evolved from a molecular signature company into an IVD platform business🔹 What diagnostics founders need to understand about scale, systems, and adoption in 2026Chapters:01:28 Jonathan Romanowsky’s background and career in diagnostics06:20 Why he launched Kadima Spark and what companies need most today11:46 How fundraising pressure is changing commercial strategy22:00 The origin story of Inflammatix29:16 Building a platform company and preparing for launch33:23 Why some diagnostics launches succeed and others fail41:44 How early adoption really works inside health systems44:32 Jonathan’s outlook on the diagnostics market in 2026Guest: Jonathan RomanowskyMedical technology commercialization expert, co-founder of Inflammatix, and Principal at Kadima SparkLinkedIn: https://www.linkedin.com/in/jonathan-romanowsky-6a122/Host: David FilbyFounder and CEO of Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#Diagnostics #Commercialization #Inflammatix #MedicalTechnology #IVD #Biotech #HealthTech #Reimbursement #ProductMarketFit #Fundraising #GoToMarket #ClinicalAdoption #Veracyte #CareDx #DiagnosingDx
The EU Market Access Playbook for Diagnostics Companies - Svetlana Nikic
In this episode of Diagnosing Dx, I’m joined by Svetlana Nikic, Founder of Precision Oncology Consulting.Svetlana shares her journey from Roche and Illumina into building her own consultancy focused on helping …
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In this episode of Diagnosing Dx, I’m joined by Svetlana Nikic, Founder of Precision Oncology Consulting.Svetlana shares her journey from Roche and Illumina into building her own consultancy focused on helping diagnostics companies navigate the realities of market access in Europe. We explore the gap between innovation and implementation, why strong science alone does not guarantee patient access, and what US diagnostics companies often underestimate when they look at Europe as a commercial opportunity.We also discuss what it really takes to make oncology diagnostics work across European markets, from KOL engagement and clinical utility studies to health economics, reimbursement strategy, and the complexity of regional healthcare systems. This is a practical conversation about precision oncology, policy, and why implementation may now matter more than innovation.Key takeaways:🔹 Why innovation without implementation does not create real patient impact🔹 What diagnostics companies need to understand before entering Europe🔹 Why clinical utility alone is often not enough for reimbursement in European markets🔹 How KOL engagement, local evidence, and health economics shape adoption🔹 Why diagnostics now needs more implementation focus and less innovation for innovation’s sakeGuest:Svetlana NikicLinkedIn: https://www.linkedin.com/in/svetlananikic/Host:David FilbyLinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:01:50 Svetlana Nikic’s background in diagnostics and oncology07:37 What Precision Oncology Consulting helps companies do in Europe10:25 When diagnostics companies should start planning for Europe15:23 How reimbursement works across European markets19:22 Why KOL engagement is so important for market access20:57 Choosing the right European market and identifying low-hanging fruit25:28 Why the reimbursement bar is often higher in Europe43:30 Diagnostics in 2026: implementation, policy, and what needs to change next🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#PrecisionOncology #Diagnostics #MarketAccess #Reimbursement #Europe #Oncology #BiomarkerTesting #healthcarepolicy #ClinicalUtility #HealthEconomics #CancerDiagnostics #LifeSciences #HealthCare #PrecisionMedicine #Innovation
The Future of Kidney Transplant Monitoring: Moving Beyond Biopsies - Sara Barrington, CEO of Verici Dx
In this episode of Diagnosing Dx, I’m joined by Sara Barrington, CEO at Verici Dx.Sara explains how Verici Dx is tackling one of the biggest unresolved problems in kidney transplant care: helping clinicians …
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In this episode of Diagnosing Dx, I’m joined by Sara Barrington, CEO at Verici Dx.
Sara explains how Verici Dx is tackling one of the biggest unresolved problems in kidney transplant care: helping clinicians monitor patients more precisely after transplant without relying so heavily on biopsies and legacy testing.
We explore why balancing rejection risk against unnecessary immunosuppression is so difficult, and how better molecular insight could support earlier, more accurate decisions.
We also discuss Verici Dx’s RNA sequencing and AI-driven approach, the decision to license one test to Thermo Fisher while commercialising another directly, and what it means to build a diagnostics company that went public from day one. This is a practical conversation about transplant medicine, commercialization, and better clinical decision-making.
Key takeaways:
🔹 Why post-transplant monitoring still relies too heavily on invasive and outdated methods
🔹 How RNA sequencing and AI could improve rejection prediction and patient management
🔹 Why reducing unnecessary immunosuppression is such an important clinical goal
🔹 How Verici Dx built an end-to-end transplant testing strategy across pre- and post-transplant care
🔹 What licensing, reimbursement, and public-market strategy look like in a real diagnostics company
Guest:
Sara Barrington
CEO at Verici Dx
LinkedIn: https://www.linkedin.com/in/sara-barrington-06926382/
Host:
David Filby
LinkedIn: https://www.linkedin.com/in/davidfilby/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
How Cleveland Diagnostics Is Redefining Prostate Cancer Testing
In this episode of Diagnosing Dx, I’m joined by Arnon Chait, PhD, MBA, Chief Innovation Officer at Cleveland Diagnostics.Arnon shares his journey from NASA physicist to diagnostics innovator, and explains how …
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In this episode of Diagnosing Dx, I’m joined by Arnon Chait, PhD, MBA, Chief Innovation Officer at Cleveland Diagnostics.Arnon shares his journey from NASA physicist to diagnostics innovator, and explains how Cleveland Diagnostics tackled one of the biggest challenges in prostate cancer testing: turning a widely used but flawed marker like PSA into something more clinically useful. We explore the role of protein structure and biomarkers in disease, why so many diagnostics fall short after the science is proven, and what it means to build from real clinical need rather than lab-first thinking.We also discuss the road from development to commercialization, the realities of regulatory strategy and FDA approval, and where diagnostics could be heading next as AI and new technologies reshape disease detection. This is a practical conversation about what it really takes to make diagnostics work in the real world.Key takeaways:🔹 Why strong science alone is not enough to build a successful diagnostic🔹 How Cleveland Diagnostics rethought prostate cancer testing beyond traditional PSA🔹 Why clinical utility, adoption, and reimbursement matter as much as validation🔹 What Arnon learned moving from physics and space science into diagnostics🔹 How AI and new technologies could shape the future of disease detectionGuest:Arnon Chait, PhD, MBAChief Innovation Officer, Cleveland DiagnosticsLinkedIn: https://www.linkedin.com/in/arnonchait/ Host:David FilbyFounder & CEO, Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:00:00 Introduction and background03:56 Transition from NASA to diagnostics06:48 Lessons from NASA applied to diagnostics09:40 Founding Cleveland Diagnostics and developing the prostate cancer test15:52 Clinical challenges in prostate cancer18:31 Commercialization and FDA approval21:53 Future of Cleveland Diagnostics and the impact of AI27:22 Market outlook, industry changes, and lessons learned🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#Diagnostics #ProstateCancer #Biotech #Biomarkers #Proteomics #PrecisionMedicine #MedicalDiagnostics #HealthcareInnovation #DiseaseDetection #MolecularDiagnostics #ClinicalUtility #AIinHealthcare #CancerDiagnostics #LifeSciences #DiagnosingDx
From Single Cell to Atera: The Future of Biology Measured at Scale - Serge Saxonov, Co-founder & CEO of 10x Genomics
In this episode of Diagnosing Dx, I’m joined by Serge Saxonov, Co-founder and CEO of 10x Genomics, a leader in single cell and spatial biology.Serge shares the story behind 10x Genomics, the evolution of its …
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In this episode of Diagnosing Dx, I’m joined by Serge Saxonov, Co-founder and CEO of 10x Genomics, a leader in single cell and spatial biology.
Serge shares the story behind 10x Genomics, the evolution of its foundational technologies, and the launch of Atera, a new platform designed to enable whole transcriptome analysis in tissue at scale with single cell level sensitivity. We explore why biology has been fundamentally limited by the way we measure it, what changes when those constraints are removed, and how better tools can open up entirely new possibilities for discovery and precision medicine.
We also discuss the intersection of AI and biology, the challenge of translating research tools into clinical impact, and what it takes to build and scale a category-defining company in life sciences. From innovation and platform thinking to talent, culture, and the future of biotech, this is a practical conversation about how the next generation of biology tools could shape healthcare.
Key takeaways:
🔹 How 10x Genomics helped define the single cell and spatial biology category
🔹 Why better measurement tools can fundamentally change what is possible in biology
🔹 How AI and biology together could accelerate discovery and precision medicine
🔹 Why most research technologies never make it into the clinic
🔹 What skills, culture, and execution will matter most in biotech over the next decade
Guest:
Serge Saxonov
Co-founder and CEO, 10x Genomics
LinkedIn: https://www.linkedin.com/in/serge-saxonov-7b42572/
Host:
David Filby
Founder and CEO of Elevra Consulting
LinkedIn: www.linkedin.com/in/davidfilby/
Key chapters:
00:00 Introduction and background of Serge Saxonov
14:32 The birth of 10x Genomics
25:54 The future of disease understanding and diagnostics
28:09 Evolution of 10x Genomics and market fit
34:25 Building culture, talent, and innovation at scale
38:27 Skills for the future in the age of AI
40:47 The convergence of AI and biology for precision medicine
46:51 Future directions for 10x Genomics and new technologies
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
True At-Home Diagnostics: Reshaping Infectious Disease with Nathalya Mamane, CEO of Anywhere Dx
In this episode of Diagnosing Dx, I’m joined by Nathalya Mamane, Co-Founder and CEO at Anywhere Dx.Nathalya shares the origin story behind Anywhere Dx and how a personal pain point led her to build a …
Shownotes
In this episode of Diagnosing Dx, I’m joined by Nathalya Mamane, Co-Founder and CEO at Anywhere Dx.
Nathalya shares the origin story behind Anywhere Dx and how a personal pain point led her to build a diagnostics company focused on bringing molecular testing into the home. We explore why the current standard of care for infectious disease testing is still too slow, too expensive, and too dependent on centralised infrastructure, and what COVID revealed about how people actually want to engage with diagnostics when access and convenience matter most.
We also discuss what it really takes to build an at-home diagnostic that can scale, from creating a fully disposable, instrument-free molecular platform to navigating regulatory validation, strategic partnerships, and the commercial realities of diagnostics today. This is a practical conversation about access, simplicity, and what it means to design diagnostics for real consumer use rather than idealised clinical workflows.
Key takeaways:
🔹 Why most at-home diagnostics still fall short on simplicity and scalability
🔹 How Anywhere Dx is approaching low-cost, disposable molecular testing
🔹 Why strategic partnerships are critical for commercialising diagnostics effectively
🔹 What COVID revealed about consumer behaviour and diagnostic access
🔹 Why funding, validation, and regulatory strategy remain major hurdles in diagnostics
Guest:
Nathalya Mamane
LinkedIn: www.linkedin.com/in/nathalya-mamane/
Learn more about Anywhere Dx: https://www.anywhere.health/
Host:
David Filby
LinkedIn: www.linkedin.com/in/davidfilby/
Learn more about Elevra Consulting: https://elevraconsulting.com/
Key chapters:
01:48 Nathalya’s journey into diagnostics
03:38 The birth of Anywhere Dx
07:54 Technology and product overview
10:45 Market need, strep, and the impact on healthcare systems
14:44 Science behind the product
19:41 Development status and funding challenges
26:19 Commercial strategy, partnerships, and regulatory pathway
30:18 Investor sentiment and market outlook
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
The New Rules of Diagnostics: Lean Teams, Faster Revenue, Smarter Growth - MJ Hymes, i5 BioPartners
In this episode of Diagnosing Dx, I’m joined by MJ Hymes, Managing Partner at i5 BioPartners.MJ shares his journey from molecular biology into the commercial side of life sciences, and explains why great …
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In this episode of Diagnosing Dx, I’m joined by MJ Hymes, Managing Partner at i5 BioPartners.
MJ shares his journey from molecular biology into the commercial side of life sciences, and explains why great science alone is rarely enough to build a successful diagnostics or biotech company. We explore the gap between innovation and execution, why so many early-stage companies struggle to turn promising technology into real traction, and how the funding landscape has shifted for founders building today.
We also discuss what it takes to get a life sciences company market-ready, from building leaner models earlier on to navigating commercialization, fundraising, and strategic support at the right time. From AI and multiomics to emerging technologies in diagnostics and drug discovery, this is a practical conversation about turning early-stage science into a real business.
Key takeaways:
🔹 Why strong science alone is not enough to build a successful company
🔹 How early-stage biotech and diagnostics teams should think about commercialization sooner
🔹 Why product-market fit matters earlier than many founders realise
🔹 How the funding environment is changing for pre-seed to Series A companies
🔹 What makes a pitch deck, investor process, and go-to-market strategy more effective
Chapters:
00:00 Introduction and background of MJ Hymes
03:26 Transitioning from science to commercialization
06:16 The formation of i5 Bio Partners
09:41 Market trends and outsourcing in life sciences
12:20 Supporting early-stage companies and revenue generation
18:15 Exciting developments in life sciences
21:21 Common gaps in early-stage companies
24:36 Fundraising strategies, pitch decks, and market insights
30:39 Establishing product-market fit
33:33 Future plans for i5 Bio Partners
Guest:
MJ Hymes
LinkedIn: https://www.linkedin.com/in/matthewhymes
Host:
David Filby
LinkedIn: https://www.linkedin.com/in/davidfilby/
Resources mentioned:
BioTools Innovator Program - https://biotoolsinnovator.com/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
“Wait and Watch” Is Failing Cancer Patients — Harbinger Health on What Comes Next
In this episode of Diagnosing Dx, I’m joined by Ajit Singh, CEO at Harbinger Health.Ajit has spent decades building, scaling, and investing in diagnostics companies, and this conversation draws on that full …
Shownotes
In this episode of Diagnosing Dx, I’m joined by Ajit Singh, CEO at Harbinger Health.Ajit has spent decades building, scaling, and investing in diagnostics companies, and this conversation draws on that full perspective. We explore why cancer diagnosis remains one of the biggest unresolved problems in care, what happens after suspicion enters the system, and why so many patients still face delays, uncertainty, and fragmented pathways before they get answers.Ajit explains how Harbinger Health is approaching this challenge, not by competing directly with existing screening models, but by helping define a new category focused on resolving ambiguity earlier and more effectively. We also discuss what it takes to build in diagnostics today: operational agility, leadership transitions, stakeholder complexity, commercialisation strategy, and the capital landscape shaping biotech in 2026.This is one of the most important conversations we’ve had on Diagnosing Dx, a practical look at what separates diagnostics companies that launch from those that actually scale.Key takeaways:🔹 Why healthcare innovation depends on nimbleness, not just process🔹 What it takes to build a new category in cancer detection🔹 Why leadership needs to evolve as a diagnostics company grows🔹 How strong positioning and ecosystem leverage can shape fundraising success🔹 Why stakeholder complexity is one of the biggest barriers to adoptionKey chapters:00:00 Introduction to diagnostics, capital, and the market landscape03:57 Ajit Singh’s career journey and lessons from Siemens10:02 Moving from corporate leadership to startup life12:57 Harbinger Health and the challenge of cancer diagnosis18:48 Building a new category in cancer detection23:52 Early testing, commercialization, and market adoption30:52 Leadership transition, company growth, and scaling33:15 Venture capital, funding, and future growth strategy37:08 Navigating complexity in healthcare and the role of mentorship43:06 Future milestones, product launches, and the capital landscapeGuest:Ajit SinghCEO, Harbinger Health
LinkedIn: https://www.linkedin.com/in/ajit-singh-flagship/
Host: David FilbyCEO, Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
Women Wait 11 Years for a Diagnosis, Endometrics Are Changing That - Yana Aznavour
This week I’m joined by Yana Aznavour, MD, PhD, OB-GYN surgeon and Founder & CEO of Endometrics.We unpack one of the biggest failures in modern healthcare: why women are still waiting up to 11 years for an …
Shownotes
This week I’m joined by Yana Aznavour, MD, PhD, OB-GYN surgeon and Founder & CEO of Endometrics.
We unpack one of the biggest failures in modern healthcare: why women are still waiting up to 11 years for an endometriosis diagnosis, why the current standard still relies on surgery, and what it takes to build a diagnostic that clinicians will actually trust and use.
This conversation goes beyond the science. We also explore why so many diagnostics fail at the point of adoption, what founders consistently get wrong when bringing new tests to market, and why evidence, workflow fit, and clinical credibility matter just as much as innovation itself.
Key takeaways:
🔹 Why endometriosis diagnosis still takes years for so many women
🔹 How a non-invasive diagnostic could change the standard of care
🔹 Why trust, evidence, and workflow fit determine whether a test gets adopted
🔹 What founders often miss when building and commercialising diagnostics
Chapters:
00:00 Introduction to Yana Aznavour and Endometrics
03:45 Transition from Clinical Practice to Entrepreneurship
06:51 The Vision Behind Endometrics
09:49 Recent Achievements and Recognition
12:52 Understanding the Unmet Needs in Women's Health
15:58 Current Status and Future Plans for Endometrics
19:00 Challenges and Opportunities in the Diagnostics Market
22:00 The Importance of Clinical Impact in Innovation
25:04 Building a Strong Team and Advisory Board
27:53 Future Directions and Expanding the Platform
Resources mentioned:
RADx® Tech ACT ENDO Challenge (NIH) - https://www.nichd.nih.gov/research/supported/challenges/radx-tech-endometriosis
PMWC Conference - https://pmwcintl.com/
Health Equity Business Accelerator (Blue Cross Blue Shield of Massachusetts / MassChallenge) - https://masschallenge.org/heba-2026/
Berkeley SkyDeck Fund - https://skydeck.vc/
Granatus Ventures - https://www.granatusventures.com/
Supernode Ventures - https://www.supernode.vc/
First Spark Ventures - https://www.firstsparkventures.com/Guest:
Yana Aznavour, MD, PhD
LinkedIn: https://www.linkedin.com/in/yana-aznavour-md/
Host:
David Filby
LinkedIn: https://www.linkedin.com/in/davidfilby/
Diagnosing WDx is a sister series from Diagnosing Dx, hosted by Elevra Consulting, spotlighting the gaps, opportunities, and innovations shaping the future of women’s diagnostics.
Learn more about Elevra Consulting: https://elevraconsulting.com/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics.
Finding Lung Cancer Before It’s Too Late: From Uncertainty to Action
In this episode of Diagnosing Dx, I’m joined by Maria Zannes, Chief Executive Officer and Director at bioAffinity Technologies.Maria shares her journey from journalism and business leadership into diagnostics …
Shownotes
In this episode of Diagnosing Dx, I’m joined by Maria Zannes, Chief Executive Officer and Director at bioAffinity Technologies.
Maria shares her journey from journalism and business leadership into diagnostics, and explains how bioAffinity Technologies is building a non-invasive platform for lung disease diagnosis, starting with early lung cancer detection. We explore the limitations of current pathways for indeterminate pulmonary nodules, how CyPath Lung is designed to support faster, more confident decision-making, and why earlier detection can have such a major impact on outcomes.
We also discuss what it really takes to build and scale in diagnostics, from clinical validation and workflow adoption to balancing commercialization with continued innovation. From lung cancer screening and clinical trials to asthma, COPD, and future opportunities in the platform, this is a practical conversation about bringing meaningful diagnostic advances to market.
Key takeaways:
🔹 Why early detection remains one of the biggest opportunities in lung cancer care
🔹 How non-invasive testing could improve patient comfort and clinical decision-making
🔹 Why strong science, clinical validation, and commercial execution all matter in diagnostics
🔹 How bioAffinity Technologies is balancing commercialization with continued discovery and innovation
🔹 What the company’s upcoming military and VA clinical trial could mean for wider adoption
Chapters:
00:00 Introduction
02:24 Why Texas is becoming a hub for diagnostics companies
02:58 Maria Zannes’ background and the origins of bioAffinity Technologies
05:42 Personal motivation, team building, and the role of science in innovation
09:27 bioAffinity’s platform technology and how CyPath Lung works
11:31 Early lung cancer detection, screening awareness, and non-invasive testing
16:25 Commercial strategy, test performance, and real-world use cases
20:02 Team growth, company milestones, and the journey to commercialization
23:27 Clinical validation, the upcoming military and VA trial, and the economic case for CyPath Lung
31:36 Company setup, future growth, therapeutic potential, and what’s next
Guest:
Maria Zannes
LinkedIn: https://www.linkedin.com/in/maria-zannes-32496815/
Host:
David Filby
LinkedIn: https://www.linkedin.com/in/davidfilby/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.
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