Policy and Legal

Policy and Legal

FDA Issues Guidance for Rapid At-Home Tests

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The FDA announced new standards for companies seeking regulatory approval of rapid at-home COVID-19 tests, reports Bloomberg Law.

Why it’s good: Creating a fast, cheap test that can be used regularly at home would allow people to test themselves once or twice a week, or before coming into contact with others—giving them the ability to quarantine when necessary and reduce the likelihood of spreading the illness.

But not so fast: The FDA’S rules for rapid at-home COVID-19 tests are pretty strict, which could discourage some companies from giving it a try, according to USA Today.

Xtra help: On Tuesday, The XPRIZE—a nonprofit organization that hosts public competitions— announced a $5 million prize for “five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15” (also from USA Today). An additional $50 million will be available to help scale up manufacturing for any contestant.

The NAM’s view: “Long wait times for tests can present a personnel challenge for manufacturers that have workers who might have been exposed outside the workplace,” said NAM Vice President of Infrastructure, Innovation and Human Resources Policy Robyn Boerstling. “The NAM recently joined a letter to ensure more federal resources are committed to testing. We are focusing our advocacy efforts on solutions that will provide more robust and reliable testing solutions in every community.”

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