AT First Diagnostic LLC an
emerging worldwide marketing leader in rapid diagnostic test kits, today
announced that a recent evaluation conducted by the Walter Reed Army
Institute of Research of the FirstVue(TM) HBSAG Test, was released at the
Advanced Technology Applications for Combat Casualty Care meeting,
sponsored by the Department of Defense. The purpose of the evaluation,
entitled "Laboratory Evaluation of Hepatitis B Rapid Test for Use in
Screening Walking Blood Bank Donors," was to determine the best rapid HBSAG
test to use for screening blood donors for Hepatitis B ("HBSAG") in the
theater of war. The FirstVue(TM) HBSAG test was selected as the preferred
test based on all facets of the study evaluation.
Out of all manufactures in the rapid diagnostic industry, six rapid
tests were initially selected based on an evaluation of published claims
and sensitivity testing using HBSAG positive samples. Those tests were then
compared in a comprehensive evaluation of test performance using plasma and
blood specimens. The study indicated that the FirstVue(TM) HBSAG test had
the highest sensitivity (95.4%) and the highest specificity (99.7%) among
all the tests evaluated. In addition, the evaluation indicated that the
FirstVue(TM) HBSAG test detected HBSAG antibodies approximately three days
sooner than available laboratory-based enzyme immunoassays. Early detection
of seroconversion is an important measure of the sensitivity of a test and
means that Hepatitis B infection can now be identified even with relatively
recent exposure.
"We are very pleased with the results of the Walter Reed evaluation,
it's just another confirmation of the quality of our product line and of
the HBSAG rapid test we are providing the military," said Jonathan Barash
President of AT First Diagnostic. "We are eager to complete our paperwork
for the FirstVue(TM) HBSAG test and submit our findings and applications
for both FDA and CE registrations on this product. Based on the performance
data generated to date, we believe this test will play an important role in
identifying HBSAG infections in the future and will enable infected
individuals to receive the proper care and treatment they need."
This extensive study was conducted at The Walter Reed Army Institute of
Research and involved investigators from the Walter Reed Army Institute of
Research Division of Retrovirology, The U.S. Military HIV Research Program,
Walter Reed Army Institute of Research Division of Military Casualty
Research, the U.S. Army Blood Program, the Army Medical Department Center
and School, the Robertson Blood Center and the American Red Cross.
Rapid Hepatitis "B" or "C" tests are not currently available for
commercial sale in the United States by the U.S. Food and Drug
Administration ("FDA"). AT First Diagnostic is in the process of collecting
all the technical data together in order to obtain FDA guidance and
approvals for this HBSAG test utilizing multiple specimen types, whole
blood, plasma and serum. The data stage is nearing completion and a
pre-market application will be in progress for submission to the FDA soon.
Hepatitis B is a potentially life-threatening liver infection caused by
the Hepatitis B virus. It is a major global health issue and the most
serious type of viral hepatitis. It can cause chronic liver disease and
puts people at high risk of death from cirrhosis of the liver and liver
cancer.
Approximately 2 billion people worldwide have been infected with the
virus and about 350 million live with chronic infection. About 25% of
adults who become chronically infected during childhood later die from
liver cancer or cirrhosis (scarring of the liver). Hepatitis B virus is 50
to 100 times more infectious than HIV. Most people who develop chronic
Hepatitis B infection are not aware that they have the disease.
About AT First Diagnostic LLC
AT First Diagnostic LLC, Coral Springs, FL USA (Privately Held)
markets, develops, and contract manufactures rapid medical devices using
proprietary technologies under their brands FirstVue(TM) & inSTIcheck(TM);
products include a wide range of various infectious disease tests for
Chlamydia, Gonorrhea, Syphilis, etc... These tests are sold in the United
States and internationally to clinical laboratories, hospitals, clinics,
community organizations and other public health organizations,
distributors, government agencies, physicians' offices, and commercial and
industrial entities. For more information please go to
firstdiagnostic.
About the Walter Reed Army Institute of Research
Walter Reed Army Institute of Research (WRAIR) is the largest, most
diverse and oldest laboratory in the US Army Medical Research and Material
Command. It conducts research on a range of military relevant issues,
including naturally occurring infectious diseases, combat casualty care
operational health hazards. WRAIR is the Department of Defense's lead
agency for infectious disease research and a crucial source of research
support for medical product development.
About the United States Military HIV Research Program
The U.S. Military HIV Research Program (USMHRP) is dedicated to,
prevention, disease surveillance and care and treatment for HIV. USMHRP's
extensive diagnostics expertise including familiarity with HIV rapid tests
led the U.S. Army Blood Program to engage with USMHRP for this HBSAG rapid
test evaluation.
Important Information
This press release contains certain forward-looking statements,
including with respect to products, product performance, clinical studies,
and regulatory submissions and approvals. Although forward-looking
statements help to provide complete information about future prospects,
readers should keep in mind that forward-looking statements may not be
reliable. The forward-looking statements are made as of the date of this
press release and AT First Diagnostic undertakes no duty to update these
statements.
AT First Diagnostic LLC
firstdiagnostic