By Steve Baragona
Federal regulators are allowing hospitals and other laboratories to develop their own tests for the coronavirus in an effort to relieve what critics say is a shortage of testing for the virus.
The urgency for testing is growing as health officials report several new coronavirus cases in the United States and the country’s first death — a man in his 50s from Washington state.
The new policy unveiled on Saturday by the U.S. Food and Drug Administration (FDA), follows criticism that a lack of testing has allowed the virus to spread undetected.
“It’s going to be really useful for greatly expanding the number of places that can do the tests,” said Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security.
Hospitals have been sending samples to the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta for testing. Getting results takes 48 hours.
Problems with CDC test
The CDC had produced a test for health departments across the country to use. But many reported problems with the tests giving inconclusive results. The problem was traced to an improperly manufactured ingredient. The CDC said the test could be used with the other components. In addition, it plans to send out new test kits to public health labs.
In the meantime, however, the problems limited the ability of health care workers to test patients for coronavirus.
“If we had the ability to test earlier, I’m sure we would have identified patients earlier,” said Jeff Duchin, an official of Seattle & King County Public Health, during a conference call with reporters.
Washington state identified two new cases on Friday, including one with no known connection to other cases, which raises concerns that the virus is spreading undetected.
The New York State health department, some hospital labs and others had developed their own tests. But since they had not been approved by the FDA, their results were not considered valid.
Hospital labs had criticized the approval process in a letter to Congress Friday, according to The Washington Post.
“This regulatory process is significantly more stringent than that required for every other virus” that the labs test for, the letter said.
New FDA policy
On Saturday, the FDA issued a new policy allowing these labs to develop their own assays, and issued instructions for how to validate the tests.
“This approval will expedite wait time and improve New York’s ability to more effectively manage the coronavirus situation as it unfolds,” New York Governor Andrew Cuomo said in a statement.
Rather than needing to send tests to Atlanta, or even to a state health lab, tests will be available at local hospitals or commercial labs.
“The closer we can put it towards patients, the better it’ll be for clinicians,” Nuzzo, of Johns Hopkins, said.