Hepatitis Resource Center


First and Only FDA-Approved Quantitative HCV Viral Load Assay

    TARRYTOWN, N.Y., April 3 /PRNewswire-FirstCall/ -- The Diagnostics
Division of Bayer HealthCare LLC, a member of the Bayer Group (NYSE: BAY),
announced today that it has received premarket approval after expedited review
from the U.S. Food and Drug Administration (FDA) for its VERSANT(R) HCV RNA
3.0 Assay (bDNA)*, a predictive test that directly measures hepatitis C virus
RNA levels in serum or plasma. The VERSANT(R) HCV viral load assay is the
first and only FDA-approved quantitative test to measure HCV viral load
levels, and will aid physicians by guiding therapeutic decisions early in
    Approximately 4 million people in the United States(1) and 170 million
people worldwide(2) are infected with HCV. The level of viral load, or HCV
RNA, in a patient's blood can identify, early in treatment, patients who may
not respond to further therapy. Utilizing an accurate HCV RNA quantitative
assay such as the VERSANT(R) HCV viral load assay can help clinicians decide
if therapy should be discontinued, thereby avoiding the unnecessary side
effects of prolonged treatment.
    "Current therapeutic recommendations rely on the accurate determination of
HCV viral levels to assess a patient's potential response to treatment.  This
is evidenced by a 2 log(subscript 10) (100 fold or 99 percent) reduction in
viral load at week twelve of therapy," said Eugene R. Schiff, MD, Director,
Center for Liver Diseases, University of Miami School of Medicine. "Since this
viral measurement is essential to the clinical decision to continue or
discontinue therapy, a reliable result as generated by the Bayer HCV bDNA
assay affords great confidence in patient care."
    The VERSANT(R) HCV viral load assay is intended as an aid in the
management of HCV-infected patients undergoing antiviral therapy.
    NIH Recommendations
    The importance of quantitative assessment of HCV RNA levels in predicting
patient response to antiviral therapy is reflected in the recent (2002)
National Institutes of Health (NIH) Consensus Development Conference Final
Statement on Management of Hepatitis C. The NIH Statement notes that "early
viral response (EVR), defined as a minimum 2 log decrease in viral load during
the first 12 weeks of treatment, is predictive of sustained viral response
(SVR) and should be a routine part of monitoring patients with genotype 1.
Patients who fail to achieve an EVR at week 12 of treatment have only a small
chance of achieving an SVR even if therapy is continued for a full year.
Treatment need not be extended beyond 12 weeks in these patients."(3) Thus,
the NIH recommends that testing for an EVR should be a routine part of patient
    Expedited Review
    FDA granted Bayer an expedited review of its premarket approval
application on July 26, 2002. The FDA grants such reviews for products that
provide treatment or diagnosis of life-threatening or irretrievably
debilitating diseases or conditions and for which no approved alternative
exists. VERSANT(R) HCV viral load assay is cleared for marketing in most of
the world, is approved in Canada and compliant with European Union
    Quantitative Detection
    The VERSANT(R) HCV viral load assay directly measures HCV viral levels in
serum or plasma using branched DNA (bDNA) signal amplification technology with
the Bayer System 340 bDNA analyzer. The test measures HCV levels over a wide
quantitation range of 615 to 7.7 million HCV RNA IU/mL, and has been validated
for all six HCV genotypes (1-6).
    Bayer Diagnostics NAD: Infectious Disease Testing
    Complimenting the new VERSANT(R) HCV viral load assay, the VERSANT(R) HCV
RNA Qualitative Assay Transcription-Mediated Amplification (TMA) provides the
most sensitive test for HCV RNA (less than 10 IU/mL) for the determination of
active HCV infection.
    "Bayer is in a unique position as we are the only molecular diagnostic
company with two FDA-approved assays designed to measure HCV RNA," said Dr.
Peter Knueppel, senior vice president, Nucleic Acid Diagnostics business
segment.  He added that the VERSANT(R) HCV genotype assay (LiPA)** determines
the main types of HCV virus.
    "These assays comprise the majority of our worldwide market-leading HCV
product line, and are an important part of our strategy to solidify our
position as a leader in infectious disease nucleic acid testing," he
    Bayer's nucleic acid portfolio for infectious disease also includes
VERSANT(R) assays for hepatitis B virus** and human immunodeficiency virus, as
well as the TRUGENE(TM) HIV-1 Genotyping Test and its GuideLines 6.0 Rules
interpretive software. The Bayer System 340 bDNA Analyzer and data management
software products automate measurements and analysis, reducing manual steps
and human error, leading to greater confidence in results.
    Hepatitis, a general term that means inflammation of the liver, can be
caused by viruses, bacteria, drugs (both prescription and abused substances),
toxins, or excess alcohol intake. Only within the last decade have clinicians
been able to differentiate the five major types of viral hepatitis referred to
by the letters A, B, C, D and E. Hepatitis C (HCV) is a blood-borne viral
infection of the liver spread primarily by direct contact with human blood.
The major causes of HCV infection worldwide are use of unscreened blood
transfusions, and re-use of needles and syringes that have not been adequately
    The current standard treatment for HCV is combination therapy of pegylated
interferon and ribavarin given for 48 weeks for type 1 HCV genotype or
24 weeks for other genotypes. Only a fraction of those infected are diagnosed
and treated with available anti-viral medications.(4)
    Nucleic Acid Testing (NAT)
    Nucleic acid tests use state-of-the-art technologies that enable
laboratories to test for the presence of infectious agents (viruses or
bacteria) by measuring the amount of the pathogen's genetic material (DNA or
RNA) in a blood sample. Unlike other types of in-vitro diagnostics, which
typically measure the body's response to infection or disease, nucleic acid
tests are a direct measurement of the presence of the pathogen.
    About Bayer Diagnostics
    With approximately 7,000 employees worldwide and 2001 sales of
$1.8 billion, Bayer Diagnostics (, based in Tarrytown, New
York, U.S.A., is one of the largest diagnostic businesses in the world. The
organization supports customers in 100 countries through an extensive
portfolio of central, self-testing, nucleic acid and near patient care
diagnostics systems and services for use in the assessment and management of
health, including the areas of cardiovascular and kidney disease, oncology,
virology, women's health and diabetes. Bayer Diagnostics' global headquarters
in the United States operates as part of Bayer HealthCare LLC, a member of the
worldwide Bayer HealthCare group.
    About Bayer HealthCare
    Bayer HealthCare, a subgroup of Bayer AG with annual sales amounting to
some 10 billion Euro, is one of the world's leading, innovative companies in
the health care and medical products industry. Bayer HealthCare combines the
global activities of the Animal Health, Biological Products, Consumer Care,
Diagnostics and Pharmaceuticals divisions. More than 34,000 employees work for
Bayer HealthCare worldwide.
    Our work at Bayer HealthCare is to discover and manufacture innovative
products for the purpose of improving human and animal health worldwide. Our
products enhance well-being and quality of life by diagnosing, preventing and
treating disease.
    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
     *  The VERSANT HCV RNA 3.0 Assay (bDNA) is intended for use as an aid
        in the management of HCV-infected patients undergoing anti-viral
        therapy. The assay measures HCV RNA levels at baseline and during
        treatment and is useful in predicting non-response to HCV therapy.
        For information on limitations of the procedure or information that
        may affect the interpretation of test results contact your clinical
        laboratory or Bayer HealthCare LLC, Diagnostics Division.
     ** Available for research use only, not for use in diagnostic
     1 U.S. Centers for Disease Control and Prevention.
       Viral hepatitis C: fact sheet.
     2 World Health Organization.  Hepatitis C: fact sheet 164, revised
       October 2000.
     3 National Institutes of Health.  National Institutes of Health Consensus
       Development Conference Statement: Management of Hepatitis C: 2002 -
       June 10-12, 2002.  Revised September 12, 2002.
     4 Ibid
SOURCE Bayer HealthCare LLC


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