Hologic announced that it has validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and completed an application for emergency use notification (EUA) to the U.S. Food and Drug Administration (FDA), according to a press release from the company.
Hologic said it is making the testing workflow available to customers in the United States while it awaits FDA action on its EUA application under FDA rules that allow diagnostics companies to do this during the COVID-19 public health emergency.
Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are re-tested individually to determine which patient or patients are infected.
Hologic said it believes it is the first test manufacturer in the country to validate and launch a pooling workflow that ensures highly accurate detection of the SARS-CoV-2 virus. Commercial laboratories Quest and LabCorp have already been granted EUAs from the FDA for their approaches to pooled testing.
By allowing samples from multiple individuals to be tested simultaneously, pooling is expected to help laboratories deliver increasing numbers of molecular test results more quickly. However, pooled testing works best in areas with a low prevalence of SARS-CoV-2 infections, meaning most results are expected to be negative.
Hologic’s Aptima and Panther Fusion SARS-CoV-2 assays detect the genetic material of the virus and run on fully automated testing platforms that return initial results in approximately three hours, the company said. The Aptima SARS-CoV-2 test runs on Hologic’s Panther system, and the Panther Fusion SARS-CoV-2 test runs on the Panther Fusion system.
Hologic said the project was funded “in whole or in part” with money from a $8.9-million contract with the U.S. Department of Health and Human Services (HHS).
