Widespread testing is necessary to open the country back up, but sending people outside to get them could end up with more exposure. That’s where at-home tests come in
reached out to five scientists and doctors — including some working for companies developing tests — to sort out the status of at-home testing for. All agreed the main challenge is regulations.
This test would still involve a doctor to authorize the kit being sent to a patient in their home, and then to discuss results with the patient. “I think startups have done themselves a disservice saying it’s a direct-to-consumer model,” Dr. Shantanu Nundy, a physician, community health advocate, and chief medical officer at Accolade, a population health company. “People have an impression that they were thinking of sending test kits without a physician or provider in the loop.
“The doctor or nurse will use CDC guidelines to decide who should be getting tested,” says Scanwell Chief Medical Officer Jack Jeng. “As things progress, we anticipate the people who can get the test will expand, but right now, given the expected demand for testing services, we want to start with the highest-risk patients.”
According to Jeng, Scanwell’s test kit is licensed from a Chinese manufacturer whose product was already approved by China’s version of the CDC. For PCR tests, Nundy points out that many at-home test companies would be sending samples to the same established labs that are already analyzing similar tests from hospitals.
Overall, there’s no reason to believe at-home testing cannot be done as effectively as it is in hospitals, but the FDA needs to approve it. “It’s not a technically challenging issue,” Martin says. “It’s a regulatory issue.”For diagnostic tests, companies have to run trials to ensure that they work. In the case of at-home testing, one of the things they’d need to prove is that patients can follow the directions and get as good a result as if it were administered by a professional.
Alex Greninger, an assistant director of the University of Washington’s clinical virology lab, which received approval via EUA for one the first COVID-19 tests in the country, says it makes sense that the FDA is waiting for case-by-case data for at-home testing. “It’s not unreasonable for the FDA to look for this data given the crush of demand and various suppliers looking to meet that demand,” he says. “Ensuring sample integrity and test integrity are not small items.”No one is certain.
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