Business COVID-19 Startups

Digital Health Startup Everlywell Gets FDA Green Light For COVID-19 Test Home Collection Kit

When Julia Cheek founded Austin-based Everlywell in 2015, it was with the goal of putting an end to the traditional lab experience and making it something that is “useful, convenient and affordable.”

Fast-forward five years and now the company is dealing with something it never could have anticipated. It’s gone from offering individuals access to at-home collection lab tests for cholesterol, diabetes and hormones (among other things) to also being a go-to for COVID-19 testing.

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On May 16, the U.S. Food and Drug Administration granted Everlywell emergency use authorization (EUA) for its COVID-19 Test Home Collection Kit.

What is monumentous about this is that the test represents the first standalone at-home sample collection kit that can be used with certain authorized tests, according to the FDA. The kit will be available for individual purchase by month’s end, according to the company.

So what does all this mean actually? Well, for one, people will be able to test for COVID-19 from the comfort of their homes using the kit. According to a statement by Everlywell, its EUA is the first to be issued to a digital health company which connects people and organizations with laboratory testing and is not a laboratory or diagnostics manufacturer.

Specifically, the company added, it is also “the only EUA for at-home collection COVID-19 testing that is not tied to one specific lab and allows the company to work with a number of certified labs offering several authorized tests, rather than being limited to a single laboratory or a single test.”

In a statement, Dr. Frank Ong, chief medical and scientific officer at Everlywell, said the fact that the startup has been working with a growing number of authorized laboratories over time will allow it “to scale COVID-19 testing for Americans where they need it most–in their homes.”

Supplies will be “limited” to start, but the company says it will be increasing its capacity weekly.

Everlywell claims the test kit will be offered at no profit to the company with the $109 price going to cover its costs, such as overnight shipping to the lab, lab processing fees, physician review and diagnosis, and kit components. The company says that its test for health care providers and organizations is also offered at no profit.

“Widespread access to convenient testing will play a crucial role in the country’s ability to address the pandemic and prevent overburdening our healthcare facilities,” Cheek said.

Everlywell has raised $50 million in venture funding over its lifetime from the likes of Highland Capital Partners and Next Coast Ventures, according to Crunchbase data.

Illustration: Li-Anne Dias

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