Wheel, imaware Roll Out FDA-Approved At-Home COVID-19 Tests

March 23, 2020
at-home testing
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Wheel and imaware are teaming up to bring COVID-19 testing to where many vulnerable people need it most — their homes. The two digital health startups are providing home-based COVID-19 testing to patients across Texas. But unlike other at-home tests, these tests will be administered by trained clinicians.

This is important because the Food and Drug Administration recently updated its testing guidelines for the novel coronavirus, saying that it does not authorize at-home tests where samples are self-collected by patients. This throws a wrench in the testing plans of other healthcare startups, but Wheel and imaware’s clinician-administered distinction keeps it safe.

A company spokesperson confirmed to Built In that the test has been authorized by the FDA. The Centers for Disease Control and Prevention has also reportedly approved the test.

To get a test, patients must first be screened through imaware’s online portal. If the screening determines that the patient is eligible, a Wheel clinician will deliver a test to the patient’s home within 24 hours. The clinician will then administer the test and later notify the patient of the result, providing ongoing care if the person tests positive for COVID-19.

The two companies plan to roll out 5,000 tests across Texas this week, with plans to later increase that number to 10,000 per week. By the end of April, they hope to provide up to 100,000 tests to people across the country each week.

The test currently costs $135, which includes access to Wheel’s clinicians and telemedicine services.

“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,” Wheel CEO and founder Michelle Davey said in a statement. “By providing a home-based option for testing that starts with a virtual clinical assessment and then is administered in-home by a registered clinician, we are making more tests available to those who need them most — ensuring that tests are not directed away from areas of greatest need.”

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