The U.S. Food and Drug Administration on Monday granted emergency use authorization for two new commercial COVID-19 diagnostic tests, growing the number of tests available to four, in addition to tests from the 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, 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.
COVID-19 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, the company 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 COVID-19 within 3.5 hours from sample to result.
Last week, HHS announced a $699K award to Hologic, through its Biomedical Advanced Research and Development Authority (BARDA), for development of the COVID-19 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 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.
The FDA also issued emergency use authortization to LabCorp for its COVID-19 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.
This story first appeared in our sister publication, Genomeweb.
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