The Food and Drug Administration has updated an emergency use authorization for a test that can be used on people without symptoms or who are suspected of being infected with the virus causing COVID-19 for other reasons. The FDA in March had granted emergency use authorization for Hologic's assay to test symptomatic people.
The Marlborough, Mass.-based firm, which claims its assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people, expects its availability to play a key role in identifying early infection in exposed individuals, as well as in reopening schools, workplaces, and the economy in general.
The FDA also authorized Hologic's pooling protocol for symptomatic testing. The protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing.
A negative result means that all five people have tested negative for COVID-19. In cases of a positive result, all five samples are retested individually to determine which patient or patients are infected. A high level of analytical sensitivity is especially important when testing pooled samples, Hologic noted. Results can return in approximately three hours.
Hologic noted that high analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.
"Accurately identifying individuals early in the course of infection so they can quarantine before passing on the virus is critical to stemming the spread of this pandemic," Kevin Thornal, president of Hologic's diagnostic solutions division, said in a statement.
The FDA authorized Hologic's asymptomatic screening claim based on available analytical data as well as the company's commitment to submit results from an ongoing clinical evaluation with several laboratory partners, the firm said.
Hologic is also pursuing emergency use authorization for asymptomatic testing for a second molecular diagnostic test that received the authorization in May for testing people with COVID-19 symptoms.
Hologic noted that the Centers for Disease Control and Prevention recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals.
This story first appeared in Modern Healthcare's sister publication GenomeWeb.
