Genalyte announces availability of high-speed COVID-19 antibody test

May 21, 2020

Genalyte has announced the availability of its rapid COVID-19 serology panel on its Maverick platform. The panel tests for the detection of IgG and IgM antibodies that the body produces in response to the novel coronavirus (SARS-CoV-2), according to the company’s press release.

Genalyte’s SARS-CoV-2 Multi-Antigen Serology Panel is designed to run on the company’s Maverick Diagnostic system. 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,” he said.

Genalyte’s SARS-CoV-2 Multi-Antigen Serology Panel tests for IgM and IgG antibodies against 12 unique viral antigens. IgG antibodies, in particular, remain long after a person has recovered and are believed to be a marker of sustained immunity, although the duration of immunity to SARS-CoV-2 needs further study.   Utilizing a machine learning approach, the panel was able to eliminate false positives, achieving 100 percent specificity on a cohort of 300 negative patients. Genalyte’s 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 EUA submission with the FDA for the SARS-CoV-2 Multi-Antigen Serology Panel. Genalyte is making the test 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.”

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