Diagnosing Dx

David Filby
  • 5.0 (1)
  • LIFE SCIENCES
  • UPDATED WEEKLY

The Voices that represent the Diagnostics and Genomics Industry. How do we transform cutting-edge scientific discoveries into life-saving Diagnostics? On Diagnosing Dx, we delve into the innovation in science driving Dx forward, pick apart the challenges companies are seeing in the industry and highlight success stories that deserve representation. Join us as we engage with leading researchers and innovators who are at the forefront of diagnostics. Gain unfiltered insights from experts revolutionizing the industry. Learn to: 🔹 Navigate the complexities for companies in the diagnostic space 🔹 Understand emerging science 🔹 Talk strategy on how to survive and thrive 🔹 Give insight into the future from industry leaders Essential listening for everyone involved in bringing new sciences to life in the Dx and Omics industry, Subscribe now!

  1. How Cleveland Diagnostics Is Redefining Prostate Cancer Testing

    1D AGO

    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 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 detection Guest: Arnon Chait, PhD, MBA Chief Innovation Officer, Cleveland Diagnostics LinkedIn: https://www.linkedin.com/in/arnonchait/ Host: David Filby Founder & CEO, Elevra Consulting LinkedIn: https://www.linkedin.com/in/davidfilby/ Chapters: 00:00 Introduction and background 03:56 Transition from NASA to diagnostics 06:48 Lessons from NASA applied to diagnostics 09:40 Founding Cleveland Diagnostics and developing the prostate cancer test 15:52 Clinical challenges in prostate cancer 18:31 Commercialization and FDA approval 21:53 Future of Cleveland Diagnostics and the impact of AI 27:22 Market outlook, industry changes, and lessons learned 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

    45 min
  2. From Single Cell to Atera: The Future of Biology Measured at Scale - Serge Saxonov, Co-founder & CEO of 10x Genomics

    APR 28

    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 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.

    47 min
  3. True At-Home Diagnostics: Reshaping Infectious Disease with Nathalya Mamane, CEO of Anywhere Dx

    APR 26

    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 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.

    41 min
  4. The New Rules of Diagnostics: Lean Teams, Faster Revenue, Smarter Growth - MJ Hymes, i5 BioPartners

    APR 21

    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 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.

    41 min
  5. “Wait and Watch” Is Failing Cancer Patients — Harbinger Health on What Comes Next

    APR 14

    “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 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 adoption Key chapters: 00:00 Introduction to diagnostics, capital, and the market landscape 03:57 Ajit Singh’s career journey and lessons from Siemens 10:02 Moving from corporate leadership to startup life 12:57 Harbinger Health and the challenge of cancer diagnosis 18:48 Building a new category in cancer detection 23:52 Early testing, commercialization, and market adoption 30:52 Leadership transition, company growth, and scaling 33:15 Venture capital, funding, and future growth strategy 37:08 Navigating complexity in healthcare and the role of mentorship 43:06 Future milestones, product launches, and the capital landscape Guest: Ajit Singh CEO, Harbinger Health LinkedIn: ⁠https://www.linkedin.com/in/ajit-singh-flagship/⁠ Host: David Filby CEO, 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.

    49 min
  6. Women Wait 11 Years for a Diagnosis, Endometrics Are Changing That - Yana Aznavour

    APR 7

    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 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.

    36 min
  7. Finding Lung Cancer Before It’s Too Late: From Uncertainty to Action

    MAR 30

    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, 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.

    43 min
  8. Scaling Precision Medicine: Faster Reports, Smarter Trials, Better Care - Garreth Hippe at GenomOncology

    MAR 24

    Scaling Precision Medicine: Faster Reports, Smarter Trials, Better Care - Garreth Hippe at GenomOncology

    In this episode of Diagnosing Dx, I’m joined by ⁠Garreth Hippe⁠, Chief Commercial Officer at ⁠GenomOncology⁠, a software company helping turn complex genomic data into faster, more actionable decisions in oncology. Garreth has spent much of his career in clinical genomics, bioinformatics, and healthcare software, and in this conversation we explore how the field has evolved over the last 20 years, from far slower sequencing workflows to a point where whole genomes can now be analysed in clinically meaningful timeframes. We also unpack how GenomOncology is helping labs bring genomic reporting in-house, reduce turnaround times, ease pressure on molecular pathologists, and match patients to relevant clinical trials before those opportunities are missed. A big part of the discussion focuses on AI, not as hype, but as a real force multiplier in healthcare software. Garreth shares how it is accelerating development, improving reporting workflows, and opening up new ways to work with clinical and omics data. We also discuss why genomics is still underused in parts of oncology, where adoption is heading next, and why whole genome sequencing could play a much bigger role in the future of cancer care. Key takeaways: 🔹 How software is helping translate genomic complexity into clinical action 🔹 Why clinical trial matching remains such a critical challenge in oncology 🔹 Where AI could have the biggest impact across precision medicine 🔹 Why whole genome sequencing may define the future of cancer care Chapters: 00:00 Introduction 01:56 Garreth Hippe’s background in clinical genomics and software 03:04 What clinical genomics means: somatic vs germline testing 05:28 How software in genomics has evolved over the last 20 years 07:14 AI in healthcare and precision medicine 09:34 What GenomOncology does and where it fits in the oncology workflow 15:14 How AI is accelerating product development and lean growth 20:21 The core problems GenomOncology is solving in reporting and clinical trial matching 26:10 Company progress, product development, and commercial milestones 33:46 Adoption challenges in genomics and the future of whole genome sequencing 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

    42 min
See All (41)

About

The Voices that represent the Diagnostics and Genomics Industry. How do we transform cutting-edge scientific discoveries into life-saving Diagnostics? On Diagnosing Dx, we delve into the innovation in science driving Dx forward, pick apart the challenges companies are seeing in the industry and highlight success stories that deserve representation. Join us as we engage with leading researchers and innovators who are at the forefront of diagnostics. Gain unfiltered insights from experts revolutionizing the industry. Learn to: 🔹 Navigate the complexities for companies in the diagnostic space 🔹 Understand emerging science 🔹 Talk strategy on how to survive and thrive 🔹 Give insight into the future from industry leaders Essential listening for everyone involved in bringing new sciences to life in the Dx and Omics industry, Subscribe now!

Information

  • Creator
    David Filby
  • Years Active
    2025 - 2026
  • Episodes
    41