Bayer Diagnostics Receives FDA Approval for First Fully-Automated Human Immunodeficiency Virus (HIV) Antibody Test
June 21 2006 - 9:50AM
PR Newswire (US)
- New Test Detects antibodies to HIV 1, HIV 2 and HIV 1 - Subtype O
on Bayer's ADVIA Centaur Immunoassay System - TARRYTOWN, N.Y., June
21 /PRNewswire-FirstCall/ -- Bayer HealthCare Diagnostics Division,
a member of the Bayer Group (NYSE:BAY), today announced that the
first fully-automated test for antibodies for human
immunodeficiency virus, called EHIV (Human Immunodeficiency Virus,
Enhanced), has received U.S. Food and Drug Administration (FDA)
approval for use on the ADVIA Centaur(R) Immunoassay System.
Bayer's ADVIA Centaur EHIV test is an in vitro diagnostic
immunoassay for the qualitative determination of antibodies to HIV
1, HIV 2 and HIV 1 -- sub-type O in human serum and plasma. ADVIA
Centaur EHIV is the only fully-automated FDA-approved test that
contains a range of recombinant proteins and sub-type O peptide for
the detection of antibodies to HIV-1, HIV- 2, and sub-type O
peptide. This meets the worldwide healthcare standards for
detecting all known types of HIV infection. With its availability
on Bayer's ADVIA Centaur, the EHIV fully-automated testing process
eliminates manual labor and provides advanced features such as:
automatic algorithm processing, cascade reflex testing,
user-defined panels, and automatic repeats of critical samples.
Combined with security and verification features, such as use of
sample tips and assay verification processes, ADVIA Centaur EHIV
allows laboratorians to increase their HIV testing productivity
with enhanced confidence in their HIV results. "With the addition
of the EHIV test, Bayer offers the most comprehensive fully
automated infectious disease portfolio in the United States, thus
enabling laboratorians to enhance their level of testing and aid
physicians in making treatment decisions," said Tony Bihl,
President, Bayer Diagnostics. The Bayer automated infectious
diseases testing portfolio also includes testing for hepatitis A, B
and C: HBsAg, HBsAg Confirmatory, HBsAb, HBc-T, HBc-IgM, HCV, HAV-T
and HAV-IgM. The EHIV test is developed, manufactured and sold by
Bayer Diagnostics for Ortho Clinical (Ortho) Diagnostics, a
subsidiary of Johnson & Johnson (NYSE: JNJ), under an agreement
entered into with Bayer, Ortho and Chiron Corporation (NASDAQ:CHIR)
in 2001. Under the terms of the agreement, Bayer will not represent
the product for blood or plasma screening. About ADVIA Centaur
Immunoassay System In addition to testing for infectious diseases,
the ADVIA Centaur(R) Immunoassay System provides testing for a
broad range of conditions, including cancer, cardiovascular
diseases, fertility, anemia, thyroid diseases, allergy, metabolic
diseases and therapeutic drug monitoring. The ADVIA Centaur System
provides productivity, ease of use, automation and expanded
capabilities for cost-effective workstation consolidation. About
Bayer HealthCare Diagnostics Division Bayer HealthCare Diagnostics
Division, based in Tarrytown, New York, U.S.A, is one of the
world's market leaders in diagnostics for critical and intensive
care, hematology, DCA (hemoglobin A1C), urinalysis, immunology,
clinical chemistry and molecular testing. With operations in more
than 100 countries, Bayer Diagnostics offers an extensive portfolio
of diagnostic systems, point of care testing, molecular
diagnostics, laboratory automation and productivity solutions and
services to hospitals and health care organizations, laboratories
and physician's offices across the world. Bayer Diagnostics'
extensive portfolio covers a myriad of disease states, including:
allergy, anemia, autoimmune, cardiopulmonary care,
cardiovascular/heart, congenital, diabetes, fertility, infectious
diseases/AIDS, urinary tract infections, immunosuppressants,
kidney, metabolic function, therapeutic drug monitoring, thyroid
functions, oncology, and virology. Bayer HealthCare Diagnostics
Division operates as part of Bayer HealthCare LLC, a member of the
worldwide Bayer HealthCare group. About Bayer HealthCare AG Bayer
HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. Bayer
HealthCare generated sales amounting to some 9.4 billion euros and
employed 33.800 people worldwide in 2005. The company combines the
global activities of the Animal Health, Consumer Care, Diabetes
Care, Diagnostics and Pharmaceuticals divisions. The new
Pharmaceuticals division was established on January 1, 2006, and
comprises the former Biological Products and Pharmaceutical
divisions. Pharmaceuticals now has three business units:
Hematology/Cardiology, Oncology and Primary Care. Bayer
HealthCare's aim is to discover and manufacture products that will
improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and
treating diseases. This news release contains forward-looking
statements based on current assumptions and forecasts made by Bayer
Group management. Various known and unknown risks, uncertainties
and other factors could lead to material differences between the
actual future results, financial situation, development or
performance of the company and the estimates given here. These
factors include those discussed in our public reports filed with
the Frankfurt Stock Exchange and with the U.S. Securities and
Exchange Commission (including our Form 20-F). The company assumes
no liability whatsoever to update these forward-looking statements
or to conform them to future events or developments. DATASOURCE:
Bayer HealthCare CONTACT: Susan Oelerking, Bayer Diagnostics,
+1-914-366-1807 Web site: http://www.bayerdiag.com/
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