What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN.

In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth and Strategy Development at VentureWell. VentureWell has been involved with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program.

Listen to this episode to learn more about the RADx Tech II program to fast-track eligible technologies to market in 2021.

• Under this RADx Tech II solicitation, NIBIB is seeking proposals to accelerate validation, manufacturing scale up, and commercialization of innovative COVID-19 testing capabilities.
• Capabilities include the full range of COVID testing from antigen to labs and POC to over-the-counter (OTC).
• Mark is starting to see some rapid evolution with some exciting technologies that are starting to come up in the pipeline of the market.
• It’s unfortunate that it took COVID-19 to spark innovation and acceleration of bringing products and technologies to the market.
• Unmet needs still exist, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.
• How are tests holding up to variants? Adjust and modify tests to be as fast and responsive to address variant capabilities.
• RADx Tech I versus Tech II programs will follow a similar phased-based approach for funding, infrastructure, and other systems. Less data is needed, but the data still needs to hold up.

“It’s labs, point of care, it’s antigen, it’s over-the-counter, really the full-range of COVID testing.”

“Now, we’re really starting to see some really rapid evolution with some really exciting technologies that are starting to come up in the pipeline of the market.”

“Everyone kind of knows, everyone has an expertise. Everyone has the same goal. People are letting go of both ego and showing up with tons of humility about what can I do to help? How can I add value?”

“We still understand that there are some unmet needs, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.”

Mark Marino - LinkedIn

RADx Tech II - POCTRN - CIMIT

VentureWell Home Page - Welcome to VentureWell

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National Institute of Biomedical Imaging and Bioengineering (NIBIB)

FDA - Emergency Use Authorization (EUA)

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