No at-home test kits for Covid-19 are currently approved, the U.S. Food and Drug Administration warned.
In the last week, a slew of startups have rolled out their own at-home Covid-19 tests, as a national shortage has left many scrambling for answers. Several people with symptoms of the disease have said they were unable to get tested — even doctors and nurses.
At-home test kits might seem like the perfect solution. But not so fast, the FDA said. The agency hasn’t yet approved any self-administered tests, and has begun to see “unauthorized fraudulent test kits” being marketed to detect Covid-19.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” FDA Commissioner Dr. Steven Hahn wrote in a statement on Friday. “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, and we are actively working with test developers in this space.”
Everlywell, a home-testing startup, said last week that it would offer at-home tests for Covid-19 in 47 states for $135. Two more startups, Wheel and imaware, said they would offer in-home testing administered by clinicians for the same price, starting in Texas.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In a statement, Everlywell said it was working with the FDA on a way to facilitate sample self-collection in a home setting. In the meantime, the company is making the test kits available to hospitals and healthcare companies who commit to providing it for free to healthcare workers and high-risk, symptomatic patients affected by the testing shortage. The tests will be administered by healthcare providers.
Everlywell said it had 30,000 at-home collection kits available, and was working with laboratories that were operating within the FDA’s emergency use authorization guidelines.
For its part, Wheel said its tests met guidelines from the FDA and the Centers for Disease Control and Prevention (CDC), since they are administered by clinicians. The tests are administered after an initial telehealth visit, with additional follow-up after the test results are received. In Texas, Clinical Pathology Laboratories Inc. is processing the tests.
“Self-collected COVID-19 swab tests are potentially at greater risk for inaccurate results, and not currently authorized by the FDA. Wheel clinicians assess individual eligibility for the test via a telehealth platform,” the company wrote in an emailed statement.
Tests administered by the Centers for Disease Control and Prevention, while a scare commodity, are free. Most health insurance plans will also cover the related visit for testing free of charge.
Earlier this month, Vice President Mike Pence had said that 1.5 million test kits would soon be available. But as of Sunday, he said 254,000 tests had been conducted, with many state labs saying they are running short on the swabs and reagents needed to run the tests.
Local health agencies hope to ramp up testing capacity in coming weeks as private companies get involved. Several companies, including Thermo Fisher, Roche and Quest Diagnostics, have received emergency use authorizations from the FDA for their Covid-19 tests.
This article has been updated with a statement from Everlywell.
Photo credit: David Hecker, Getty Images
