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 adoption

Chapters:
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 companies

Guest: Alexander Bagaev
Chief Product Officer at BostonGene

LinkedIn: https://www.linkedin.com/in/alexander-bagaev-5548166b/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

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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 beyond

Guest: Talia Cohen Solal
CEO at NeuroKaire

LinkedIn: 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

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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

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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

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

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.

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

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.

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.

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/

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