Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

Follow the latest updates of the outbreak on our timeline.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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’.