Genalyte, San Diego, has launched its SARS-CoV-2 multiantigen serology panel, which runs on the company’s Maverick platform and tests for the presence of IgG and IgM antibodies produced in response to SARS-CoV-2.
Genalyte currently has the capacity to test 250,000 patients per month; the company is scaling up to test more than 7,500,000 patients per month by September. Utilizing a machine-learning approach, Genalyte’s panel is able to eliminate false positives, achieving 100% specificity on a cohort of 300 negative patients.
“Our Maverick instrument allows us to deliver central lab-quality results in 20 minutes at decentralized testing locations,” says Cary Gunn, chief executive officer 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.”
The SARS-CoV-2 serology panel will initially be available through participating physician offices and employers interested in testing their at-risk workforce.
Genalyte has filed an emergency use authorization submission with FDA for the SARS-CoV-2 multiantigen serology panel. The company is making the test immediately available as a laboratory-developed test, as outlined in FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
For more information, visit Genalyte.