Everlywell, a leading digital health company and provider of one of the only FDA-authorized at-home sample collection kits for COVID-19, today announced it has entered into a distribution agreement with diagnostics manufacturer Cellex, the first company to receive an FDA Emergency Use Authorization for a COVID-19 antibody test.
The agreement would enable Everlywell to distribute Cellex’s point of care rapid antigen test to organizations in need of diagnostic tests for COVID-19, pending Cellex’s receipt of an Emergency Use Authorization from the Food and Drug Administration (FDA). The Cellex qSARS-COV-2 Antigen Rapid Test, which is designed to be administered by healthcare professionals, includes a disposable rapid antigen testing lateral flow device to detect active COVID-19 infection.
Organizations who purchase tests through Everlywell will have access to Everlywell Lens, a comprehensive reporting dashboard which provides visibility into the status of individual tests, from registration to digital results. Lens helps organizations stay compliant with federal and local reporting requirements by automatically transmitting test results to mandated agencies using a HIPAA-compliant interface. Everlywell’s digital interface also allows test-takers to easily share their results to gain entry into workplaces or events where a negative COVID-19 test result is required.
“Staying compliant with federal, state, and local reporting mandates for COVID-19 is a complex task that many executives, human resources teams, and healthcare professionals have been left to navigate on their own,” said Dr. Frank Ong, Chief Medical and Scientific Officer at Everlywell.
“With this agreement, we are pleased to collaborate with Cellex in planning to offer organizations two things that will help them stay safe and compliant: access to rapid antigen tests from Cellex, a noted leader in the field of COVID-19 test development, and access to Everlywell Lens, a reporting solution that helps keep organizations safe and compliant.”
In addition to Everlywell Lens, organizations will have access to Everlywell’s team of clinically-trained support representatives for their testing staff and test-takers. If the test receives Emergency Use Authorization from the FDA, the Cellex qSARS-COV-2 Antigen Rapid Test will be available to organizations located within the U.S.
Following receipt of the first FDA emergency use authorization of its kind for its COVID-19 Test Home Collection Kit in May, Everlywell’s enterprise line of business has supplied COVID-19 testing to organizations across the country, including workplaces, clinics, schools, government offices, and major health plans.
“Cellex is very excited to form a distribution partnership with Everlywell,” said Dr. X James Li, CEO of Cellex. “Everlywell is an outstanding digital health company that, in the event our antigen test receives FDA authorization, will best enable mass distribution and access to a world-class platform and spectrum of care for organizations.”
Source: Company Press Release