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

    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 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 US Chapters: 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 growth Guest: 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.

    Could a 10-Minute Test Stop Unnecessary Antibiotic Prescribing? Paul Kase, CCO - Lumos Diagnostics
  2. Sep 29

    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 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 A Chapters: 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 growth Guest: Marty Keiser Founder & CEO, IVBH LinkedIn: https://www.linkedin.com/in/martykeiser 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
  3. Sep 23

    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 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 ambitions Chapters: 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 Sagacity Guest: 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.

    What If the Patients Who Need Your Test Are Already Hiding in the EHR? Sagacity Diagnostics
  4. Sep 15

    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 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 science Chapters: 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 start Guest: 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.

    Can Strategic Partnerships Save Diagnostics Innovation? Robert Carlson
  5. Sep 9

    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 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 timelines Chapters: 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 diagnostics Guest: 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.

    Could More Frequent Blood Testing Transform How We Detect Disease?
  6. Sep 2

    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 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 adoption Chapters: 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 diagnostics Guest: 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.

    Why Are Vector-Borne Infections Still So Difficult to Diagnose?
  7. Aug 26

    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 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 companies Chapters: 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 next Guest: 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.

    What Can Diagnostics Founders Learn From Two Successful Exits? Andrew Miller
  8. Aug 18

    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 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 oncology Chapters: 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 ahead Guest: Travis Wold Chief Executive Officer at Imagenomix LinkedIn: 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.

    98% of Cancer Patients Outside the US Miss Genomic Testing. Can AI Change That?

Ratings & Reviews

5
out of 5
2 Ratings

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!

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