Diagnosing Dx

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 workflows

Chapters:
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 diagnostics

Guest: Dr Oliver Bathe
Founder & CEO, Qualisure Diagnostics
Professor of Surgery and Oncology, University of Calgary
LinkedIn: https://ca.linkedin.com/in/oliver-bathe-76a84636

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.

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 pennies

Chapters:
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 ahead

Guest: 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

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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 treatment

Chapters:
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 market

Guest: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 beginning

Chapters:
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 outlook

Guest: 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.

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 diagnostics

Chapters:
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 diagnostics

Guest: 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.

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.

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.

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.

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.

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.

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