BECTON, DICKINSON AND COMPANY By Michael Dabaie
Becton Dickinson and Co. said the U.S. Food and Drug Administration granted emergency-use authorization for a new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours.
The new test also has been CE marked to the IVD Directive (98/79/EC) for the European Economic Area.
The new emergency-use authorization includes updated information in the test's instructions for use that addresses variants of the SARS-CoV-2 virus, including variants from the U.K. and South Africa.
A computer analysis showed that 99.9% of the genetic sequences of the these variants are an identical match to at least one of the two molecular targets for the test, Becton Dickinson said. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX System, the company said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
02-12-21 0936ET
