Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay
Hologic, Inc. (Nasdaq: HOLX) has received Emergency Use Authorization (EUA) from the FDA for its Panther Fusion® SARS-CoV-2 assay, enabling testing for asymptomatic individuals. This is the first high-throughput molecular diagnostic test authorized for this purpose, aimed at identifying early infections and aiding in the reopening of schools and workplaces. The CDC's guidance supports testing for those exposed to the virus. Hologic plans to submit clinical evaluation results for further validation of its testing capabilities.
- Received EUA for Panther Fusion SARS-CoV-2 assay for asymptomatic testing.
- First high-throughput diagnostic test authorized for screening asymptomatic individuals.
- Supports CDC's strategy to limit virus spread and reopen the economy.
- None.
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that its Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. This availability is expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces and the economy in general.
The U.S. Centers for Disease Control and Prevention (CDC) recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.1
“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.”
A recent report published by the FDA compared more than 50 COVID-19 tests and demonstrated that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market. High analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.
The asymptomatic screening claim was authorized based on available analytical data as well as Hologic’s commitment to submit results from an ongoing clinical evaluation that is underway with several laboratory partners.
Hologic is also pursuing an EUA for asymptomatic testing for its Aptima® SARS-CoV-2 assay, another molecular diagnostic test for COVID-19.
Sample Pooling Protocol
In addition, the FDA authorized the company’s pooling protocol, which was previously disclosed on August 11, 2020, for symptomatic testing with the Panther Fusion SARS-CoV-2 assay. 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. A high level of analytical sensitivity is especially important when testing pooled samples.
The Panther Fusion SARS-CoV-2 test runs on Hologic’s fully automated Panther® Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low, medium or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory developed tests. Hologic’s Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens. More than 2,000 Panther systems have been installed in clinical diagnostic laboratories around the world.
About COVID-19
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
About Hologic
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.
Forward-Looking Statements
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Panther Fusion® SARS-CoV-2 assay and Aptima® SARS-CoV-2 assay. There can be no assurance 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.
References:
- https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Accessed September 27, 2020.
SOURCE: Hologic, Inc.
