Biopool International Files FDA 510k Application for New Miniquant
D-dimer Assay System
VENTURA, Calif., Jan 13, 2000 (BW HealthWire) -- Biopool International
Inc. (OTCBB:BIPL) today reported that the company has filed a 510(k)
pre-market notification with the U.S. Food and Drug Administration
(FDA) for its new MiniQuant(TM) D-dimer test system, a rapid,
quantitative method for determining the fibrin degradation product
D-dimer in plasma.
The assay is performed using Biopool's MiniQuant(TM) latex
agglutination reagent and the company's MiniQuant(TM)-1, a compact
two-channel LED photo-optical detection system for use in laboratory
and emergency care environments.
The MiniQuant(TM) assay principle is based on agglutination of latex
particles exposed to Biopool's unique monoclonal antibody, the same
antibody that has been incorporated into Biopool's highly successful
Minutex(R) D-dimer kit (a qualitative test for D-dimer). The compact
size, ease of handling and rapid quantitative results provided by the
MiniQuant(TM) D-dimer test system make it suitable for both routine
laboratory testing and satellite or stat lab near-patient acute-care
testing of fibrin D-dimer.
Elevated levels of D-dimer are found in clinical conditions such as
deep vein thrombosis (DVT), pulmonary embolism (PE), disseminated
intravascular coagulation (DIC) and pregnancy complications. In recent
studies, D-dimer has proven to be one of the best in vitro diagnostic
markers for the exclusion of DVT and PE. In one such study conducted at
the Mayo Clinic, Biopool's Minutex(R) D-dimer kit proved superior to
others in ruling out PE; thereby providing the potential to avoid
complex, time-consuming, expensive and potentially hazardous additional
testing for a significant number of patients.
In another study demonstrating the superiority of Biopool's D-dimer
antibody, the Minutex(R) D-dimer assay demonstrated sensitivity for
exclusion of DVT similar to the more expensive and time-consuming ELISA
methods. Some 70 percent of the 2.5 million suspected deep vein
occlusions that present to hospitals each year are proven negative
after expensive venography and possible hospitalization. Therefore, the
ability to quantify and ease of use of the MiniQuant(TM) D-dimer test
system have the potential to offer significant reductions in
hospitalization costs and patient exposure to uncomfortable and
possibly dangerous invasive procedures.
Michael D. Bick, Ph.D., chairman and chief executive officer of
Biopool, commented: "Biopool's new MiniQuant(TM) D-dimer test system
was first presented at the 1998 Medica exposition in Dusseldorf,
Germany, where it was received with a great deal of enthusiasm.
Subsequently, clinical trials of the test system have been performed in
the U.S. at Temple University, Albert Einstein Medical Center, St.
Joseph Hospital (Providence, R.I.), Christiana Health Care and the
University of California, Davis. The system has performed extremely
well in these clinical trials, and we are very pleased to announce the
submission of the test system to the FDA. Our first generation D-dimer
assay, Minutex(R) D-dimer, remains our largest selling hemostasis
product, and the MiniQuant(TM) D-dimer system represents Biopool's
commitment to address the growing market for D-dimer determination with
new innovative formats of the test."
Founded in 1987, Biopool International develops, manufactures and
markets a full range of test kits to assess and diagnose disorders of
blood coagulation, thrombotic risk factors, fibrinolysis, platelet
function and the vascular system and specialty toxicology controls used
to monitor and measure the presence of drugs of abuse. The company's
product line is sold to hospitals, clinical laboratories, commercial
reference laboratories and research institutions on a worldwide basis
by the company's own sales representatives, as well as through an
extensive network of distributors. To learn more about Biopool, visit
the company's Web site at biopool.com.
This news release contains forward-looking statements that are based
upon current expectations that involve a number of risks and
uncertainties including, but not limited to, technological innovations
of competitors, changes in health-care regulations, litigation claims,
foreign currency fluctuation, product acceptance or changes in
government regulation of the company's products, as well as other
factors discussed in the company's last Report on Form 10-K-SB under
"Risk Factors."
Copyright (C) 2000 Business Wire. All rights reserved.
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