Hologic CEO Steve MacMillan told CNBC on Tuesday that his company was already shipping tests to labs across the country, and that it can produce as many as 600,000 of the tests in April, now that it has emergency authorization from the Food and Drug Administration.
The company’s tests are already in use after the FDA on Monday granted emergency use authorization for Hologix's Covid-19 test.
The company, which said that labs with its molecular diagnostic platform can process up to 1,150 tests in one day, had previously entered into a funding agreement with the Biomedical Advanced Research and Development Authority (BARDA) to develop the test.
In a statement on Tuesday, FDA Commissioner Stephen Hahn said the agency's device center has been working closely with diagnostic developers "... to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the Covid-19 virus."
More than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring forward for emergency approval. More than 40 laboratories have notified the FDA that they are testing or intend to begin testing soon under the agency's new policy for laboratory-developed tests.
Shares of Hologic were down 7% at $29.26 in morning trading. In premarket trading the stock had been up more than 8%. Year to date, the stock has declined more than 44%.