Trump announces FDA approved first at-home coronavirus test kit, manufactured by LabCorp
FDA Administrator Stephen Hahn said the mail-in test is manufactured by LabCorp. It can be mailed to a patient, who gives a sample on a swab
The Food and Drug Administration has approved the first at-home coronavirus test kit, President Trump announced Friday at a daily White House Coronavirus Task Force briefing.
"The FDA's been incredible," Trump said. "They've been approving many things at a pace that's never happened before, and they're being very safe about it. ... But at the same time, they're approving things at record numbers at a record rate, and it's really been helpful."
FDA Administrator Stephen Hahn said at the briefing that the test is manufactured by the clinical laboratory network LabCorp.
The test can be mailed to a patient, who gives a sample on a swab and mails it back to receive results. Hahn noted the test should not be administered without a physician's guidance.
"This normally takes years to develop," he said. "This has happened in weeks and months."
Hahn said the FDA's 18,000 employees had been working "around the clock" to review and approve or reject coronavirus treatments and tests.
Hahn said under the agency's emergency authorization approach, the FDA had reviewed and authorized 63 tests, diagnostic and serologic, and several point-of-care tests that can be administered at an emergency room or physician's office.
"We've been laser-focused on working with both industry and academia to actually make this happen," Hahn said.
He also said the FDA was working with more than 400 test developers who are pursuing approval for their diagnostic tests.