On Aug. 11, 2020, 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 emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. By allowing samples from multiple individuals to be tested simultaneously, pooling is expected to help laboratories deliver increasing numbers of highly accurate molecular test results more quickly.

Hologic 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. As described in the protocol, pooling is used most effectively in areas or populations of lower disease prevalence.

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’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 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. More than 1,100 of these automated systems are installed in U.S. clinical laboratories. Each Panther and Panther Fusion system can process more than 1,000 SARS-CoV-2 tests in 24 hours. Hologic is currently producing an average of more than one and a half million COVID-19 tests per week.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of an $8.9 million award.