Diagnosing Dx

Elevra Consulting

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!

  1. 3d ago

    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 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 field Chapters: 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 change Guest: 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.

    Why Cancer Patients Still Die From Infections We Can't Diagnose - Karius
  2. Jul 15

    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 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/ 🔔 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?
  3. Jul 7

    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 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 🔔 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
  4. Jun 30

    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 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.

    Why AI Multiomics Will Replace Ultrasound in Liver Cancer Screening with Bharat Tewarie
  5. Jun 17

    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, 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

    Start with Reimbursement and Work Backwards - Jonathan Romanowsky
  6. Jun 16

    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, 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 2026 Chapters: 01:28 Jonathan Romanowsky’s background and career in diagnostics 06:20 Why he launched Kadima Spark and what companies need most today 11:46 How fundraising pressure is changing commercial strategy 22:00 The origin story of Inflammatix 29:16 Building a platform company and preparing for launch 33:23 Why some diagnostics launches succeed and others fail 41:44 How early adoption really works inside health systems 44:32 Jonathan’s outlook on the diagnostics market in 2026 Guest: Jonathan Romanowsky Medical technology commercialization expert, co-founder of Inflammatix, and Principal at Kadima Spark LinkedIn: https://www.linkedin.com/in/jonathan-romanowsky-6a122/ 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.

    Start with Reimbursement and Work Backwards - Jonathan Romanowsky
  7. May 28

    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 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 EU Market Access Playbook for Diagnostics Companies - Svetlana Nikic
  8. May 27

    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 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 sake Chapters: 01:50 Svetlana Nikic’s background in diagnostics and oncology 07:37 What Precision Oncology Consulting helps companies do in Europe 10:25 When diagnostics companies should start planning for Europe 15:23 How reimbursement works across European markets 19:22 Why KOL engagement is so important for market access 20:57 Choosing the right European market and identifying low-hanging fruit 25:28 Why the reimbursement bar is often higher in Europe 43:30 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.

    The EU Market Access Playbook for Diagnostics Companies - Svetlana Nikic

About

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!