The widely available, high-throughput molecular diagnostic test could play a key role in identifying early infection in exposed individuals, according to Hologic. Early identification of COVID-19 infections is needed for the safe reopening of schools, workplaces and the overall economy.
“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,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic.
“The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available,” Thornal said in a news release.
Hologic pointed to a recent FDA report in which Hologic’s assays ranked among most analytically sensitive of the fully automated, high-throughput molecular tests on the market. FDA granted its emergency use authorization for Hologic’s asymptomatic screening claim based on available analytical data and Hologic’s commitment to submit results from an ongoing clinical evaluation.
Hologic is also seeking an EUA for asymptomatic testing for its Aptima SARS-CoV-2 assay — another molecular diagnostic test for COVID-19.