Genalyte has released its rapid SARS-CoV-2 Multi-Antigen Serology Panel, a COVID-19 diagnostic that can detect antibodies in patients who have had the virus.
The diagnostic is run on Genalyte’s Maverick platform. The panel tests for the detection of IgG and IgM antibodies that the body produces in response to SARS-CoV-2. Utilizing a machine learning approach, the panel is able to eliminate false positives, achieving 100% specificity on a cohort of 300 negative patients, according to the company.
Genalyte has filed an EUA submission with the FDA for the test but is making it immediately available as a Laboratory Developed Test (LDT) as outlined in the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.”
The test will initially be available through participating physician offices and employers interested in testing their at-risk workforce.
Currently, Genalyte has the capacity to test 250,000 patients per month and the company is scaling to test over 7,500,000 patients per month by September.
“Our Maverick instrument allows us to deliver central lab-quality results in 20 minutes at decentralized testing locations,” said Cary Gunn, CEO at Genalyte. “High-quality, rapid testing is needed to provide immediate feedback to worried patients and to help employers make effective return-to-work decisions.”
