With only 12 state and local health laboratories able to test for the novel coronavirus, public health labs are asking the US Food and Drug Administration for permission to create their own tests for the virus.
“We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories,” the Association of Public Health Laboratories wrote in a letter to FDA Commissioner Stephen Hahn on Monday.
The association represents the 150 largest public health labs across the country and is asking the FDA for a special exemption to create its own diagnostics.
“We find ourselves in a situation that requires a quicker local response,” the association wrote.
While the CDC currently has no backlog or delay in testing, the lab association’s CEO, Scott Becker, told CNN that its concern is not about the current situation, but for when community spread of the virus increases.
“We want to encourage and ensure that we have the test closest to the population,” Becker said.
The CDC announced on Feb. 6 that 200 test kits would be distributed to labs across the United States. The kits needed to be verified by the local health laboratories to ensure they were working. Less than a week later, Dr. Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said some labs that had received the tests were getting inconclusive results, and components of the tests would need to be remade.
The CDC has been working to resolve the testing kit issue but has yet to provide a timeline about when labs will receive new tests.