-- In Time of Extraordinary Need, New Protocol Expected to Help Laboratories Deliver Greater Quantities of Highly Accurate Molecular Test Results and Reduce Turnaround Times --
Hologic, Inc. (Nasdaq: HOLX) announced today 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.
"By providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time," said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. "Pooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic."
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.
The pooling workflow for the Aptima and Panther Fusion SARS-CoV-2 assays has not yet been reviewed by FDA. This workflow is being made available in accordance with Section IV.C. of FDA’s policy for diagnostic tests for Coronavirus disease – 2019 during the public health emergency at https://www.fda.gov/media/135659/download [fda.gov].
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 under Contract No. 75A50120P00100.
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s SARS-CoV-2 assays. There can be no assurance that these products will receive full market authorization or achieve the benefits described herein. In addition, there can be no assurance that these products will be manufactured in adequate quantities to meet demand, be commercially successful, or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.
Hologic, Aptima, Panther, Panther Fusion and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.
SOURCE: Hologic, Inc.
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