Genalyte has launched instrument-based SARS-CoV-2 Multi-Antigen Serology Panel test on its Maverick platform for the coronavirus (Covid-19) detection.
The rapid Covid-19 serology panel tests for IgM and IgG antibodies against 12 unique viral antigens.
It will help Genalyte’s Maverick Diagnostic System, approved by the US Food and Drug Administration (FDA), to expand antibody testing in the fight against the pandemic.
The company noted that its antibody test and results represent a significant step in helping to develop an understanding of the Covid-19. It may offer information on how long antibodies stay in the body and if they are less susceptible to reinfection.
IgG antibodies, which are considered to be a marker of sustained immunity, remain in the body long after a person has recovered. The panel uses a machine learning approach to eliminate false positives.
The company said that it has achieved 100% specificity on a group of 300 negative patients.
Genalyte CEO Cary Gunn said: “Our Maverick instrument allows us to deliver central lab-quality results in 20 minutes at decentralised testing locations.
“High-quality, rapid testing is needed to provide immediate feedback to worried patients and to help employers make effective return-to-work decisions.”
At present, Genalyte has the capacity to test 250,000 patients a month. It intends to further ramp up the capacity to test more than 7,500,000 patients a month by September.
The company is currently working with the FDA for the emergency use authorisation (EUA) for SARS-CoV-2 Multi-Antigen Serology Panel.
Initially, the panel will be available to participating physician offices and employers interested in testing their at-risk workforce.
It is immediately available as a Laboratory Developed Test (LDT) under the FDA’s ‘Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency’.