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Another startup has launched a COVID-19 ‘at-home’ test, but the FDA might soon crack down

The FDA would prefer that you not do it this way.

Another startup has launched a COVID-19 ‘at-home’ test, but the FDA might soon crack down
[Photo: sonreir es gratis/iStock]

You can now purchase a COVID-19 test to take at home, although the FDA is not officially on board.

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Starting today, Vault Health, a men’s telehealth company, is offering $150 COVID-19 tests: To order, you fill out a form with your symptoms, and a Vault physician “orders” the test for you, and then watches you take a saliva sample via video. Once their lab (which is a partnership with Rutgers Clinical Genomics Laboratory) receives your sample, you will receive results within 48-72 hours. The company claims that the test is priced “at no-profit.” The kit tests for the presence of SARS-CoV-2 in saliva. (It is not an antibody test, which would indicate previous exposure.)

This is playing fast and loose with FDA guidelines. The FDA website says that the FDA “has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” Vault’s partner lab is approved to process tests, listed among dozens of laboratories and manufacturers approved under an FDA Emergency Use Authorization. Vault’s EUA specifies that the sample should be collected from individuals “by their healthcare provider.”

Reached for comment, the FDA said, “At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. 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. Due to concerns with specimen stability, transport, and appropriate collection materials, self-collection at home or at sites other than designated collection sites staffed by HCPs is currently not recommended.”

A company called MicroGenDx is also offering a $99 test kit, though it requires your physician authorizing the test.

Three weeks ago, a handful of companies developed at-home testing kits under similar logic. The FDA cracked down, including a press release calling them “unauthorized fraudulent COVID-19 test kits,” and the companies removed the kits from the direct-to-consumer market. For example, Everlywell, a leader in the at-home testing market for tests ranging from allergies to fertility, announced its test March 18, and subsequently allocated tens of thousands of tests to healthcare workers.

Vault, for its part, believes it is abiding by the FDA rules as written. “In regards to the at-home collection, Vault believes that this is fundamentally different from what is often thought of as traditional ‘at-home’ collection because it is being supervised every step of the way by a medical professional [and] patients are not left to their own devices,” the company said in a statement.

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This story has been updated with additional feedback from Vault and the FDA.

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