U.S. FDA Announces Pre-Market Approval of Tetracores Rapid Anthrax Test for Clinical Use

U.S. FDA Announces Pre-Market Approval of Tetracore’s Rapid Anthrax Test for Clinical Use Alexeter Technologies would like to extend congratulations to Tetracore, Inc. for obtaining clearance this week from the U.S. Food and Drug Administration on the first rapid anthrax test approved for the clinical market. Tetracore, the manufacturer of the BioThreat Alert® Anthrax Test for environmental samples, received notification this week that their lateral flow immunoassay anthrax test (RedLine Alert™) has been approved for use in the clinical laboratory market.

After extensive trials in five clinical research centers, Tetracore’s anthrax test is the first antibody-based, rapid anthrax test to satisfy the strict requirements for safety and efficacy set by the FDA. These results come on the heels of the CDC’s findings that Tetracore’s BioThreat Alert Anthrax Test Strip was the top-performing environmental test.

In the absence of a recognized U.S. Federal authority for regulating environmental tests for B. anthracis, these results demonstrate that the Tetracore anthrax test is both safe and effective by strict federal laboratory standards.

To view the FDA and New York Times’ Press Releases, please follow:

For additional information, please contact Alexeter Technologies at (877) 591-5571 or visit our website at: http://www.alexeter.com.