The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish …
The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings. The test, developed by the California-based company Lucira Health, requires a prescription from a health care provider. People under the age of 14 also cannot perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less, according to the product’s website. Clinicians can also run the test on patients, including children under the age of 14, potentially delivering answers during a single visit to a care center or pharmacy, instead of routing a tough-to-collect sample through a lab. A handful of other tests have been cleared by the F.D.A. for at-home collection of samples, which are then shipped to a lab for processing. But Lucira’s test is the first to remove the need for an intermediary. “Today’s authorization for a complete at-home test is a significant step toward F.D.A.’s nationwide response to Covid-19,” Jeff Shuren, director of F.D.A.’s Center for Devices and Radiological Health, said in a statement.
