The on-again, off-again launch of a coronavirus test from Texas startup Everlywell is on again — sort of.
On March 23, Everlywell was supposed to start shipping 30,000 test kits to U.S. consumers. But before a single test was sent, the U.S. Food and Drug Administration (FDA) blocked the distribution of at-home, self-administered tests from Everlywell and other companies.
Now, the Austin-based company is making the tests available primarily to hospitals and other healthcare providers in the U.S. to meet a “desperate need” for front-line medical professionals to be tested.
“In this evolving health crisis, our highest priority is to ensure that the people at highest risk get the accurate testing and care they need,” Michelle Davey, CEO of Wheel Health, says in a March 23 release.
Everlywell says that effective March 23, its test is available only to hospitals and healthcare providers that offer it at no cost to their front-line workers, along with high-risk patients who exhibit coronavirus symptoms.
The company, which produces a variety of at-home lab tests, says its shift from testing of consumers to testing of healthcare workers and high-risk patients is “critically important” to help prevent the spread of what’s known as the novel coronavirus. The virus causes the highly contagious and potentially deadly COVID-19 respiratory illness.
It's been a confusing few days since Everlywell announced it was making at-home tests for consumers. On March 20, the FDA said it hadn’t authorized at-home, self-administered coronavirus tests from Everlywell or any other company. Three days later, on March 23, Dr. Deborah Birx, coronavirus coordinator for the White House, announced the federal government was clearing the way for self-swabbing coronavirus tests such as those made by Everlywell.
In a series of tweets March 23, Everlywell said it’s working with the FDA on “a path forward” for at-home coronavirus tests of consumers.
“The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection,” the federal agency says, “and we are actively working with test developers in this space.”
Everlywell unveiled a $1 million program design to spur labs to speed up development of an at-home coronavirus diagnostic test. Many labs answered the call, allowing Everlywell to set up a coronavirus testing and diagnosis system in a matter of days. For consumers, each test will cost $135. Some providers of health savings accounts and flexible spending accounts will cover these tests.
Eventually, Everlywell wants to ship 250,000 tests per week.
At the same time, another Austin startup, Wheel Health, and Houston-based Microdrop have unveiled a partnership that will provide at-home coronavirus testing administered by licensed healthcare professionals, rather than consumers themselves, and supported by telemedicine technology. The federally approved product is geared toward people at high risk of the coronavirus or people with limited access to testing. For now, it’s available only in Texas.
The test from Wheel, a telehealth provider, and Microdrop, a producer of at-home health tests, also costs $135. At the outset, the companies will roll out 5,000 test kits in Texas. After that, they plan to sell 10,000 test kits per week. Nationwide, the companies hope to offer 100,000 test kits per week by the end of April.
“Providing accurate medical guidance to people who are concerned about, or may have been exposed to, COVID-19 will determine the way this pandemic plays out in our country — and collaboration is essential to mobilizing toward this common goal rapidly and efficiently,” says Dr. Rafid Fadul, chief medical officer of Wheel.