DIAGNOSTICS AND AMERICAN BIOGENETIC SCIENCES SIGN
A RESEARCH AND LICENSE AGREEMENT FOR TpP
TpP Test Is Cleared For Marketing To Detect Levels
Of A Blood Protein Whose Levels Rise Before A Clot
NY April 3, 2001 American Biogenetic
Sciences, Inc. (ABS) (Nasdaq: MABA) announced
today that it has entered into a research and non-exclusive
license agreement with Biosite Diagnostics, Incorporated
(Nasdaq: BSTE) to validate the use of ABS Thrombus
Precursor Protein (TpP) diagnostic marker and
antibodies for potential use with Biosites rapid,
quantitative Triage Meter testing platform.
will conduct an evaluation of the TpP assay as part
of its on-going discovery program aimed at the identification
of diagnostic markers for cardiovascular and cerebrovascular
diseases. Should Biosite commercialize a product containing
ABS patented monoclonal antibodies, Biosite
will purchase the antibodies from ABS and pay milestone
fees and royalties. In assessing diagnostic utilities
of potential markers, Biosite will use blood samples
from clinical collaborators such as the Thrombolysis
In Myocardial Infarction (TIMI) study group of Brigham
and Womans Hospital, an investigative team that
has been at the forefront of clinical research of
acute coronary syndromes for the past two decades.
evaluation of TpP could further establish the utility
of this sensitive antibody-based assay and lead to
its use on Biosites point-of-care testing platform,
said Josef C. Schoell, ABS president.
recent publication1 using the TpP ELISA supports the
utility of this protein as a marker for the diagnosis
and management of chest pain patients experiencing
an MI, said David Carville, Ph.D., Cardiovascular
Consultant to ABS. After the research is completed,
TpP may emerge as a useful adjunct to future generations
of Biosite products.
assay is based on ABS highly specific patented
MH-1 monoclonal antibody, a product of its patented
Antigen-Free antibody generation technology. The TpP
diagnostic is approved for use in aiding in the risk
assessment of thrombosis and the monitoring of anticoagulant
rapid, quantitative Triage® Meter was first commercialized
as the testing platform for the Triage Cardiac System,
which provides measurements of cardiac markers. The
Triage Cardiac System aids in the diagnosis of AMI,
or heart attack, by detecting and measuring three
blood proteins (creatinine kinase [CK-MB isoenzyme],
myoglobin, and troponin I) that are released as a
result of heart muscle damage following a heart attack.
Results from the system are available within 20 minutes.
Heart Association estimates that of the 2.5 million
people admitted to critical care with heart attack-like
symptoms, only 900,000, or roughly 35 percent, have
actually experienced an acute myocardial infarction.
The Triage panel of rapid test for key cardiac markers
is designed to help rule in or rule
out heart attack as the cause of the symptoms.
Biogenetic Sciences, Inc., based in Copiague, N.Y.,
researches and develops diagnostic tests for cardio-pulmonary
conditions and infectious diseases, as well as for
new treatments for neurological disorders including
epilepsy, migraine, mania, Parkinsons disease
and Alzheimers disease.
KS, et al Clinical Usefulness of Thrombosis Precursor
Protein (TpP) in the Diagnosis of Ischemic Heart Disease
and Changes of TpP after LMWH Therapy. Proceedings
of the 03rd International Congress on Coronary Artery
Disease 2000; 443-447. Moduzzi Editore SpA, publisher.
in this press release that are not strictly historical
are "forward looking" statements within
the meaning of the Private Securities Litigation Reform
Act of 1995, and should be considered as subject to
various risks and uncertainties that could cause actual
results to differ materially from those anticipated,
including the risk that Biosite may determine not
to commercialize the TpP assay. For further details
and a discussion of these risks and uncertainties,
see the Companys Securities and Exchange Commission
filings including its annual report on Form 10-K.