Press Release RedLine Alert (TM)
For Immediate Release:
December 18, 2003 |
Inquiries: 301.258.7553 x 224
(Barry Michael) |
First
FDA Cleared Laboratory Test for Anthrax
Tetracore, Inc. announced today, December 18, 2003, that it has received
510(K) clearance from the Food and Drug Administration (FDA) for RedLine
Alert (TM), 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 % correct was 98.6%; 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 % correct was
97.2%. In addition, the RedLine Alert (TM) Test had an accuracy
of 100% in correctly differentiating B. anthracis from forty-nine
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 wishes to thank the following organizations for their help
in evaluation of this test. Brigham Young University, Department of
Microbiology (Dr. Richard Robison); U.S. Army Medical Research Institute
of Infectious Diseases (Dr. John Ezzell); Wadsworth Center,
New York State Department of Health (Dr. Nick Cirino); Los Alamos National
Laboratory (Dr. Paul Jackson), Florida Department of Health Bureau
of Laboratories - Miami (Dr. Segaran P. Pillai) , St. Michael's Hospital
Toronto, Canada ( Dr. H. Roslyn Devlin) , North Shore - Long Island
Jewish Health System Laboratories ( Dr. Christine C. Ginocchio ), and
Driscoll Childrens Hospital Microbiology Department, Corpus Christi,
Texas ( Ms. Pam Zapalac) .
The FDA press release regarding RedLine Alert (TM) can be found
at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00992.html
About Tetracore, Inc.
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.
Tetracore, Inc.
11 Firstfield Rd. Suite C
Gaithersburg, MD 20878
www.Tetracore.com
1.301.258.7553
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