Hologic Inc said on Friday the U.S. Food and Drug Administration granted emergency use authorization for its COVID-19 diagnostic test that can provide initial results in about three hours and process more than 1,000 tests in 24 hours.
Diagnostic test makers are rushing to offer their own kits to combat the fast-spreading new coronavirus that has killed nearly 300,000 people globally and hammered financial markets.
The medical device maker, which had launched its first COVID-19 test after receiving emergency use authorization in March, said it has started distribution of the latest test and expects to produce an average of 1 million tests per week.
The new test to detect the novel coronavirus, which causes the respiratory disease COVID-19, runs on the much more prevalent and available system and could help to alleviate backlogs and get more people tested, the company said during the April launch.
The company said certain aspects of the project were conducted under a contract of $13 million from the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services.
Hologic plans to apply for the CE Mark for the test in Europe later in May.
Shares of the medical device maker were up 1.6% at $52.24 before the bell.
(Reporting by Trisha Roy in Bengaluru; Editing by Sriraj Kalluvila)
