InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Ag Detect Rapid Test.
SEATTLE, Sept. 5, 2024 /PRNewswire-PRWeb/ -- With a late summer surge in COVID-19 cases fueled by new variants, effective, easy-to-use diagnostics are more important than ever. InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Ag Detect Rapid Test. With its unique patent pending design, InBios' test is an easy-to-use rapid antigen assay – requiring no instrumentation or mixing step with room temperature storage and easy-to-read results in just 20 minutes. This clearance allows the test to be used in point-of-care settings with Clinical Laboratory Improvement Amendments (CLIA) certificates of waiver; the test requires minimal training to perform.
The lateral flow immunoassay is intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in direct nasal swab specimens, collected without transport media, from individuals with symptoms of upper respiratory tract infection. The clinical performance of SCoV-2 Ag Detect Rapid Test was evaluated in a multi-site prospective study in the U.S. conducted during multiple distinct time frames between April 2021 and April 2024, which showed the specificity of the test was 99.8% and the sensitivity was 84.2%. Performance is reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.
"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.
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