C2Sense® and Princeton BioMeditech Receive Second Award from NIH RADx® Tech High Performance Program for Digitally Connected, At-Home Diagnostic Reader and Multiplex COVID-19/Flu A&B Rapid Test
WATERTOWN, Mass. and MONMOUTH JUNCTION, N.J., April 9, 2024 /PRNewswire/ -- C2Sense, Inc., experts in advanced optical sensing platforms and Princeton BioMeditech Corporation (PBM), a world leader in rapid, point-of-care (POC) diagnostics, announced today that they have secured a second National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech High Performance award. The companies are currently planning their upcoming clinical trial, regulatory submission, and transfer to manufacture.
"After rigorous testing and intensive data collection, Halo®, used in conjunction with the PBM multiplex rapid test, continues to demonstrate outstanding sensitivity and reliability," said Jason Cox, Ph.D., CEO at C2Sense. "Powered by our latest algorithm release, the price vs. performance of our Halo reader is unparalleled." Testing was conducted by the Atlanta Center for Microsystems-Engineered Point-of-Care Technologies (ACME POCT) on behalf of RADx using SARS-CoV-2 (Omicron variant) and Flu A&B viral samples.
"As a direct result of our ongoing RADx program, we have developed and released an upgraded Halo algorithm featuring enhanced line detection, sensitivity, and error correction capabilities. As always, we remain committed to providing our customers with the best possible solution for at-home testing," added Cox.
"PBM is committed to providing people with reliable testing solutions and our continued collaboration with C2Sense to develop this low cost multiplexed COVID-19/Flu A&B assay with digital results interpretation is directly aligned with that core mission," said Roger Kang, Vice President at Princeton BioMeditech.
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.
About C2Sense
C2Sense is an advanced optical sensing company with a product portfolio that delivers solutions for rapid diagnostics, authentication, and product viability assurance to benefit the health and wellbeing of people worldwide. As an MIT "Tough Tech" spinout, C2Sense develops products that leverage innovations in optical based sensing to help solve some of the world's toughest challenges. For more information on C2Sense, visit www.c2sense.com | www.haloreader.com.
About PBM
Established in 1988, Princeton BioMeditech Corporation (PBM) is a world leader in rapid diagnostics. PBM develops and manufactures high quality innovative products for consumer in-home use and professional on-site/POC use. From the one-step pregnancy test to the rapid, 3-in-1 cardiac marker panel, and now rapid, quantitative Troponin I, PBM has introduced professionals and consumers around the world to the speed, ease of use and reliability of rapid, POC diagnostics. Utilizing its patented technologies, PBM has developed and introduced an extensive menu of over 70 different rapid tests. With products in the areas of Fertility, Infectious Diseases, Drugs of Abuse, Tumor Markers, Cardiac Markers, Veterinary Diagnostics, Food and Environmental Diagnostics, PBM manufactures a wider range of simple, easy-to-use tests than any other company. For more information about PBM, visit www.PBMC.com.
The Halo reader used in conjunction with the PBM multiplex SARS-CoV2 and Flu A&B rapid test are subject to FDA review and are not available for sale.
The FDA has issued an emergency use authorization (EUA) for the PBM visually read POC multiplex rapid test that is available for sale.
SOURCE C2Sense
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