FDA Clears First Laboratory Test for Anthrax


GAITHERSBURG, Md. -- Tetracore, Inc. announced

today that it has received 510(K) clearance from the Food

and Drug Administration (FDA) for RedLine Alert, an antibody-based test

kit for use as an aid in the clinical laboratory identification of Bacillus

anthracis colonies from culture plates.

B. anthracis is the causative agent

of anthrax. The test is a lateral flow immunoassay containing a monoclonal

antibody which is specific for the presence of a cell surface protein found in

Bacillus anthracis vegetative cells. The test can be used on colonies as

early as 12 hours old. Attended time takes as little as 10 minutes and the

test can be fully completed within 20 minutes. In data submitted to the FDA on

145 Bacillus anthracis isolates, the RedLine Alert percentage correct was 98.6 percent; these isolates originated from 28 countries world-wide. This compared favorably to

another well recognized confirmatory test called gamma phage lysis, which can

require an additional day of culture to perform, whose percentage correct was 97.2 percent.

In addition, the RedLine Alert Test had an accuracy of 100 percent in correctly

differentiating B. anthracis from 49 other non-hemolytic Bacillus.

Dr. Beverly L. Mangold of Tetracore commented, "We are excited to be able to

provide a significant new clinical and public health tool to aid in protecting

against bio-terrorism threats."

Tetracore is a biotechnology R&D and product company whose mission is to

create and develop highly innovative diagnostic reagents and assays for

infectious diseases and bio-terrorism threat agents. Areas of company focus

include clinical, veterinary, and domestic preparedness testing.

Source: Tetracore, Inc.

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