The FDA has expanded the emergency authorization it granted to Hologic for its COVID-19 test, allowing it to be used to screen people showing no symptoms of the disease.
The agency also gave the company’s diagnostic, run on the high-throughput Panther Fusion laboratory platform, a green light for pooled testing—where multiple samples are combined and analyzed at once, and only retested individually if the entire batch returns a positive result.
Previously, many of the FDA’s authorizations limited testing to people who showed respiratory symptoms or had a confirmed exposure to the novel coronavirus in an effort to prioritize scarce resources to where tests might be most accurate and effective.
The agency has since approved four tests for wider screening, including Hologic’s centralized lab test, as well as kits from LabCorp, Kaiser Permanente and DxTerity Diagnostics—with the latter three also being authorized for the self-collection of samples at home.
Hologic said the new permissions for its fully automated molecular diagnostic test, capable of processing over 1,000 samples per day, will help it play a key role in reopening schools, workplaces and the economy. The Panther Fusion test was first authorized by the FDA in March.
“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 Hologic’s diagnostic solutions division. The company is also pursuing a similar emergency authorization for its separate diagnostic test for its Aptima platform.
According to a recent report published by the FDA, both Hologic’s Panther Fusion and Aptima COVID-19 tests proved to be more sensitive than automated, high-throughput diagnostics from BD, Roche and Abbott. High sensitivity is key for allowing asymptomatic screening and pooled testing, which can dilute the amount of virus particles found in a sample.
Source – FierceBiotech