INDUSTRY NEWS

FDA greenlights first Covid-19 test with sample set at home

Published Date | 2020 April 29

Regulators at the U.S. Food and Drug Administration on 21 April 2020 authorized the first coronavirus test that lets people collect a sample at home.

The diagnostic authorization — developed by testing giant LabCorp — marks the first time the agency has cleared up a Covid-19 at-home test and ends weeks of back-and-forth between the agency and companies who have tried to produce their own versions of the tests that would allow at-home sampling. The LabCorp check will be made available exclusively to health care staff and first responders who may have been exposed to the virus. Patients should obtain samples at home if a health care provider suggests the test after they have completed a questionnaire on Covid-19, and the results are expected to be available within one to two days after a sample enters the laboratory, according to the LapCorps website.

Throughout this pandemic business, test creation has been encouraged to ensure patients have access to accurate diagnostics, which includes promoting the production of safe and accurate at-home sample collection options, "FDA commissioner Stephen Hahn said Tuesday 21 April 2020.

In particular, for experiments involving the collection of home samples, the company partnered with LabCorp to ensure that the data from the collection of patient samples at home were as secure and reliable as the collection of samples at a doctor's office, hospital or other test site.

The FDA had already approved in March 2020 test of LabCorp under legislation known as an authorization for emergency use, explicitly tailored to circumstances such as the coronavirus pandemic. The firm reached out to FDA on April 5 , 2020 to recommend that it amend the authorization to allow patients to use it at home. Like previous, longer swabs, LabCorp's at-home test uses a different Q-tip-style cotton nose swab that allowed patients to examine themselves deep in the back of the nose.

The agency's authorization of the LabCorp test for home sample processing comes after a recent burst of activity between the agency and companies including Nurx, Carbon Health, and Everlywell, all of which had received approval for at-home use of their own Covid-19 tests in March.

Confusion over the constantly changing guidance from the FDA tended to lead some organizations to conclude that their tests were in the clear initially. On March 21 2020, federal regulators released stern guidance clarifying that no home tests had yet been licensed for use and advised consumers to be wary of "unauthorized fraudulent test kits." Responding to the warning, all three companies stopped marketing their kits directly to customers.

In April, two other companies began selling Covid-19 tests that let people collect saliva samples at home. The two companies — MicroGen DX and Vault Health — told on April 10, 2020 that their tests were cleared for patients to collect spit samples at home. The companies insist they are permitted to sell the tests because they are ordered by physicians and processed in certified labs. The FDA, however, remained adamant that isn’t the case, repeating its previous guidance to STAT on April 10 and emphasizing that the agency “had not authorized any Covid-19 tests for home use, including home collection.” Those tests have still not been cleared for home sample collection

The companies insist that they are licensed to sell the samples, because they are ordered by doctors and tested in accredited laboratories. Nevertheless, the FDA remained consistent this is not the case, repeating its previous guidance to STAT on April 10 and stressing that the agency "had not approved any Covid-19 home usage tests, including home testing." These tests have not yet been licensed for home sampling.