San Diego-based health care diagnostics company Genalyte has received Emergency Use Authorization from the U.S. Food and Drug Administration for its rapid COVID-19 antibody test, the company announced Thursday.
Genalyte's SARS-CoV-2 Multi-Antigen Serology Panel tests for the presence of IgG and IgM antibodies the body produces in response to the novel coronavirus. The company says the panel and Genalyte's FDA-cleared Maverick Diagnostic system can provide lab-quality results in 20 minutes at point-of-care locations.
"Our SARS-CoV-2 Multi-Antigen Serology Panel and Maverick instrument provide a much-needed, rapid testing solution that can help people understand if they have been previously infected with SARS-CoV-2," said Cary Gunn, founder and chief technology officer at Genalyte. "It enables health care professionals to confidently provide accurate, serological results in clinical and public health settings, which then enables them to better estimate how many people have been infected with SARS-CoV-2 — the virus that causes COVID-19 — and helps guide a better understanding of the virus."
The FDA's Emergency Use Authorization allows for the use of unapproved medical products during an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. Emergency Use Authorization has been granted to a large number of companies since the COVID-19 pandemic began for rapid approval of diagnostic tests, personal protective equipment, ventilators and other devices.
"An effective COVID-19 vaccination program will benefit from accurate, reliable serology testing. We are pleased to receive the Emergency Use Authorization from the FDA and look forward to being part of the solution in combating COVID-19," said Ashraf Hanna, CEO at Genalyte.
