First Instrument-Based, Rapid Test Uses Multi-Antigen Approach to Achieve Best-in-Class Sensitivity and Specificity, U.S. FDA EUA Submitted
SAN DIEGO, April 27, 2020 /PRNewswire/ — Genalyte, the company empowering physicians and patients with real-time diagnostics and healthcare analytics, announced today 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).
Genalyte’s U.S. Food and Drug Administration (FDA)-cleared Maverick™ Diagnostic System will expand antibody testing in the fight against COVID-19 with the launch of its SARS-CoV-2 Multi-Antigen Serology Panel. The antibody test and results represent a crucial step in helping to develop an understanding of the virus, including how long antibodies stay in the body and if they are less susceptible to reinfection. 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 is 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.”
About Genalyte: Genalyte is a healthcare analytics and diagnostics company that improves patient outcomes and lowers cost with real-time results for physicians and patients. Genalyte delivers rapid, actionable results to doctors through decentralized laboratory testing, backed by remote telehealth oversight and monitoring. For more information, please visit www.genalyte.com.