At VentureWell, we provide a full spectrum of commercialization services that help bring innovations from lab to market—but what does that look like in practice? Follow along our Medtech to Market series, as each blog examines a real-world success story of how we support our partners, funders, and innovators.
The investments made in health research and technology in the past five years have long-lasting positive effects, including the rapid progress of diagnostics. Many of these advancements are the result of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Technology (RADx® Tech) program. VentureWell has supported this initiative across a variety of disease areas, including serving as the Commercialization Center for the hepatitis C virus point-of-care diagnostics program.
VentureWell’s in-house business and health experts support programs and products across the commercialization pathway—with the end goal of translation and impact. We provide program strategy and development, technical and administrative award management, rapid contracting and procurement, and full-service communications and events management. We also leverage our deep network of vetted subject matter experts to provide tailored expertise for each partner.
Our commercialization services helped the test successfully receive De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the first point-of-care hepatitis C test, only 13 months after the program’s kick-off meeting. This program is an exemplar of a public-private-academic partnership getting medtech solutions to market—and in the hands of people who need them—faster.
Test-to-Treat Breakthrough
Hepatitis C can lead to liver failure, cancer, and death—devastating health outcomes that could cost the U.S. over $4 billion in the next 10 years. With a slow progression of symptoms, many people with active infection don’t know they have hepatitis C and can unknowingly expose others. Why is a point-of-care test such a game changer? Hepatitis C can be cured with antivirals, but patients have historically needed several doctor visits to confirm test results and get treatment. Patients can struggle to keep up with these appointments due to the time and cost of doctor’s visits, transportation, employment coverage, caregiving coverage, and lack of reliable access to healthcare. Every additional appointment is a barrier to patients knowing their status and receiving life-saving treatment.
The new test lets patients get tested and start antivirals in a single visit. This test-to-treat model makes the eradication of hepatitis C possible.
VentureWell Service Spotlight: Supporting a Rapid Timeline to Market
As the Commercialization Center, VentureWell provided infrastructure support to get the new test to market. This support included contracting and managing a roster of consultants who provided program management and subject matter expertise to the RADx® team; the manufacturer, Cepheid; and the regulatory lab testing vendor, MRIGlobal.
Quickly adapting to funder priorities, we got the right people on board and within budget. We responded to requests to further accelerate an already record-breaking planned timeline to market, ramping up and managing subcontractor efforts to meet milestones faster. Our comprehensive system monitoring ensured the accurate and timely tracking of contracting, billing, invoicing, and milestone data.
“VentureWell enabled a fast and efficient contracting process, reducing timelines from several months to just one to two weeks.”—Karen Peltier, MRIGlobal
We selected MRIGlobal as the vendor to provide FDA-required independent analytical testing, including limit of detection and flex studies to fine-tune sample inputs and stress tests for potential user errors. MRIGlobal is a nonprofit research organization that has developed over 70 diagnostic assays with a long track record of success.
“VentureWell enabled a fast and efficient contracting process, reducing timelines from several months to just one to two weeks, allowing teams to access funding and begin work immediately,” said Karen Peltier, associate director for Disease Detection and Diagnostics at MRIGlobal. “The VentureWell team was knowledgeable about the contracting process and supportive of MRIGlobal’s initiatives to not only follow contracting guidelines, but prioritize the science.”
Meeting the Needs of Programs and Patients
Our team of experts in biomedical engineering, technology transfer, and commercialization acceleration provides full-service support to move forward large innovation programs that will make a difference in people’s lives.
“We are proud to support NIH RADx® Tech in rapidly developing the first point-of-care hepatitis C test,” said Rebekah Neal, VentureWell’s vice president of Commercialization. “In the last 10 years, the federal government has made remarkable strides in hepatitis C care, and this new technology brings testing and treatment closer to patients.”
Interested in more commercialization success stories? Read about accelerating access to mpox diagnostic tests.
This work was funded in part with federal funds from the Centers for Disease Control and Prevention (CDC) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00013, 75N92022D00015, and 75N92022D00014.