The FDA has authorized its first COVID-19 diagnostic for broad-based screening—including for people who have not shown any symptoms and those that do not suspect they have come into contact with someone with the disease.
Previously, the agency’s testing green lights were reserved for people showing early signs of an infection, such as a fever, as well as high-risk individuals and front-line healthcare workers—both to conserve testing resources and because most diagnostics had not been proven accurate enough for screening large numbers of people without unacceptable numbers of false positive or negative results.
The new regulatory expansion goes to LabCorp’s coronavirus diagnostic test, which was first authorized by the FDA in mid-March. The agency also endorsed its use for batch testing, which allows up to five samples to be combined and analyzed at once to stretch testing supplies and speed up screening efforts.
“FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” Commissioner Stephen Hahn, M.D., said in an agency statement.
The FDA issued its first emergency authorization for pooled testing to Quest Diagnostics last week to prepare for a new, long-term surveillance phase in the U.S. response to the pandemic. Taken together, LabCorp and Quest provide more than half of the country’s commercial lab testing services.
However, the batch testing strategy works best in areas with a low prevalence of the virus by reserving tests for individuals until after the first pass returns a positive result. But COVID-19 infection rates are currently surging in many areas across the U.S., with tens of thousands of new infections per day, driving up the total number of confirmed cases from 3 million to 4 million in about two weeks.
Both Quest and LabCorp tests still require a prescription, and LabCorp said negative results from pooled tests should not be treated as definitive as the method can make the test less sensitive. Additionally, only swabs collected by a healthcare professional can be tested as a batch.
“We believe science and technology are the best ways to beat the virus, and our matrixed pooled testing method is another way LabCorp is helping to respond to this health crisis,” said Brian Caveney, chief medical officer and president of LabCorp Diagnostics, which said its robotic testing methods would not require people to be re-swabbed in a majority of cases.
“Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity,” Caveney added. “The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”