Around New England

Massachusetts Firm To Start Shipping Out More Than A Million Coronavirus Tests This Week

March 16, 2020

A Massachusetts-based firm says it has 1.5 million COVID-19 tests available now that the U.S. Food and Drug Administration issued them an Emergency Use Authorization label.

The company is Thermo Fisher Scientific, headquartered in Waltham. The company claims that it has developed a test that can diagnose coronavirus in just four hours, according to Newsweek

According to the FDA’s web site, “Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”

“CBRN” stands for “chemical, biological, radiological, or nuclear.”

Thermo Fisher Scientific reportedly would also be able to ramp up production to 2 million tests per week and potentially up to 5 million tests a week by some point in April, according to Newsweek.

“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc N. Casper, the chief executive officer of Thermo Fisher Scientific, told Newsweek.

“In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease,” he added.



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