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FDA Grants Emergency Use Authorization for Coronavirus Assays From Hologic, LabCorp

NEW YORK – The US Food and Drug Administration on Monday granted Emergency Use Authorization for Hologic's Panther Fusion SARS-CoV-2 assay, the company announced after the close of the market.

The FDA also issued EUA to Laboratory Corporation of America's coronavirus assay, as the total number of emergency-use-authorized commercial assays for detecting SARS-CoV-2, which causes COVID-19, grew to four, in addition to EUA-designated tests from the US Centers for Disease Control and Prevention and the New York State Department of Health.

Hospital, public health, and reference laboratories will be able to use the test on Hologic's fully automated, high-throughput molecular diagnostic platform, the Panther Fusion, which can provide results in less than three hours and process up to 1,150 coronavirus tests in 24 hours, the Marlborough, Massachusetts-based firm said. SARS-CoV-2 testing can be done with the same patient sample and collection vial used to test for other common respiratory viruses with symptoms similar to the coronavirus, while the random access capability of the system improves efficiency and workflow, the firm said.

The assay is a real-time, reverse transcriptase PCR in vitro diagnostic test for the qualitative detection of RNA from the coronavirus, isolated and purified from nasopharyngeal and oropharyngeal swab specimens from individuals who meet the epidemiological and clinical criteria for COVID-19.

Earlier this month, researchers in Germany said they had developed a molecular assay for detecting coronavirus on the Panther Fusion system, allowing for the detection of SARS-CoV-2 within 3.5 hours from sample to result. Last week, the US Department of Health and Human Services announced a $699K award to Hologic, through its Biomedical Advanced Research and Development Authority (BARDA), for development of the SARS-CoV-2 assay.

Hologic said it anticipates providing its lab customers tens of thousands of the coronavirus assay this month as it ramps up capacity. Starting next month, it expects to produce almost 600,000 SARS-CoV-2 tests a month, which would be a twelvefold increase in the firm's prior manufacturing capacity for similar tests running on the Panther Fusion. Hologic added that it is investing to further increase its production capacity.

"As soon as the outbreak started, our diverse team of scientists and engineers began developing a new, highly accurate test, and we have brought it to market quickly through the FDA’s emergency use process and with assistance from BARDA," Hologic Chairman, President, and CEO Steve MacMillan said in a statement.

"Making rapid and accurate diagnostic tools available to healthcare providers is critical for early detection and control of COVID-19," added BARDA Director Rick Bright. "The speed at which this assay was developed, validated, and issued EUA – less than two months – is a testament to Hologic’s commitment to helping reduce the global COVID-19 burden."

The FDA also issued EUA to LabCorp for its COVID-19 RT-PCR test. It is for the qualitative detection of nucleic acid from the coronavirus from upper and lower respiratory specimens, including nasopharyngeal or oropharyngeal swabs sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate from patients suspected of having COVID-19, according to a statement from the FDA.

The EUAs issued to Hologic and LabCorp follow similar designations issued to Roche and Thermo Fisher Scientific in the past week and comes as the Trump administration tries to lift coronavirus testing capacity after being roundly criticized for not making enough tests available amidst the pandemic. Last week, the administration touted the commercial sector for its role in that effort.