NEW YORK – Digital health company Everlywell announced Friday it has signed an agreement with Ginkgo Bioworks to distribute Access Bio's CareStart COVID-19 antigen test to organizations in need of SARS-CoV-2 diagnostic tests.
The immunochromatographic test has a disposable rapid antigen testing lateral flow device that detects active SARS-CoV-2 infection in 15 minutes, Everlywell said in a statement. The test, which detects the nucleocapsid protein antigen from SARS-CoV-2, received Emergency Use Authorization from the US Food and Drug Administration last October. Boston-based Ginkgo provided funding to Somerset, New Jersey-based Access Bio to expand the manufacturing capacity for the antigen test and agreed to offer at least 10 million of the kits through its Concentric by Ginkgo service.
Under the agreement, Austin, Texas-based Everlywell will distribute the antigen test to "workplaces, clinics, schools, government offices, and health plans," the company said. As part of the announcement, Everlywell also announced digital tools, including an online portal to distribute and ship at-home test kits regardless of manufacturer and telehealth consultations for people who receive positive results from a COVID-19 test offered by the company. Everlywell received the first EUA from the FDA for an at-home COVID-19 collection kit in May.
Financial and other terms of the agreement were not disclosed.