Benzinga | Sep 28, 2020 08:03AM EDT

Hologic Granted FDA Emergency Use Authorization For Asymptomatic COVID-19 Testing With Panther Fusion SARS-CoV-2 Assay

- Testing of Pooled Samples Also Authorized; New Claims Expected to Help Limit Spread of COVID-19, Open Economy and Schools -

Hologic, Inc. (NASDAQ:HOLX) announced today that its Panther Fusion(r) 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(r) 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(r) 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(tm) 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.