Sensible Diagnostics, a diagnostics company that has developed a real-time PCR point-of-care (POC) diagnostic platform which yields lab-grade results in approximately 10 minutes, has been selected by the Rapid Acceleration of Diagnostics (RADx) Tech program launched by the National Institutes of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health (NIH).
The program aims to speed innovation in developing, commercializing, and implementing technologies for COVID-19 testing.
The first phase of the initiative will provide Sensible with up to $1 million in non-dilutive milestone-based funding disbursed over the next three-four months to speed up the development of a multiplexed PCR respiratory viral panel for use at point-of-care.
If Sensible successfully completes its deliverables in the first phase, the company will be able to request a larger second round of non-dilutive funding under the same program. Sensible’s technology was previously developed by Curative Inc., one of the country’s largest COVID testing providers during the pandemic, according to the company.
“We are proud and excited to have been selected for such a prestigious program,” says Ernest Templin, CEO of Sensible. “As the only point-of-care system that was designed by people who have actually run point-of-care tests in the field, these funds will be put to use to further our mission of developing and commercializing one of the world’s most affordable, accessible, and accurate point-of-care PCR testing platforms.”
Sensible says it is aiming to give providers something that has been missing in point-of-care testing; a PCR test that can be performed in 10 to 15 minutes at a cost that is on par or less than not only the current molecular tests on the market, but also professional CLIA-waived antigen tests. With two tests currently in development, the RADx Tech program-funded panel that includes influenza A, influenza B, and SARS-CoV-2, and an independently funded test for group A strep, and plans to develop tests in the field of sexually transmitted infections (STIs) including HCV and HIV, and a panel for neonatal infectious disease screening, Sensible plans to be a one-stop solution for molecular POC testing, according to the company.
CLIA-waived POC testing has been identified as crucial not only as a tool during a pandemic, but also in routine clinical and emergent care. Sensible says it intends to develop and manufacture a suite of infectious disease tests that will provide clinicians with a highly accurate PCR result in 10-15 minutes. Historically, this kind of speed has been relegated to less accurate and more error-prone “rapid” antigen tests.
With Sensible’s “molecular in a box,” utilizing all required steps to run a molecular test inside a small CLIA-waived system, physician offices, and urgent care clinics can get laboratory quality molecular results in the same or less time than less accurate antigen testing, with higher reimbursement, at less cost.
This project has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001.