“We are pleased to secure FDA 510(k) clearance for our SCoV-2 Ag Detect Rapid Test, which demonstrates our commitment to support the ongoing management of COVID-19 infection through rapid diagnostics. We look forward to working with the FDA to further expand our portfolio of respiratory diagnostics,” said Estela Raychaudhuri, InBios’ president.
“As we’ve seen over the last several months, COVID infections are on the rise. Through our direct commercial efforts and our valued distribution partners, we will immediately begin our transition to the 510(k) cleared product to the more than 200,000 CLIA waived laboratories in the US,” said Wendy Bagnato, InBios’ senior marketing and sales manager. “We are grateful for the collaboration with FDA and support from our government partners in gaining this approval.”
Support to achieve the FDA clearance for the SCoV-2 Ag Detect Rapid Self-Test comes in part from a $12.7 million contract with the U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Program Management Office funded by the Defense Health Agency (DHA) through the CARES Act; and the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) under contract W81XWH-16-D-0009/Task Order W81XWH-20-F-0253 (awarded in 2020).
About InBios: Since 1996, InBios has been a leader in the development of diagnostic tests for emerging infectious diseases and biothreats. Products are designed for superior performance, efficiency and value. These include many FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more. InBios continues to anticipate and serve the growing global public health demand. Products in the pipeline include next generation platforms for tick-borne and respiratory diseases. For more information, visit www.inbios.com.
No official endorsement of third parties or their products is made or inferred.
Media Contact
Wendy Bagnato, InBios International Inc., 1 206-384-7691, [email protected], www.inbios.com
SOURCE InBios International Inc.
