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Bayer Receives FDA Approval After Expedited Review For Hepatitis C Viral Load Assay, VERSANT HCV RNA 3.0 Assay (bDNA)
  First and Only FDA-Approved Quantitative HCV Viral Load Assay
April 3, 2003, TARRYTOWN, NY - 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‰ HCV RNA 3.0 Assay (bDNA)BM__ftnref1[1], a predictive test that directly measures hepatitis C virus RNA levels in serum or plasma. The VERSANT 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 treatment.
Approximately 4 million people in the United StatesBM__ednref1[i] and 170 million people worldwideBM__ednref2[ii] 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 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 log10 (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 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."BM__ednref3[iii] Thus, the NIH recommends that testing for an EVR should be a routine part of patient monitoring.
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 HCV viral load assay is cleared for marketing in most of the world, is approved in Canada and compliant with European Union requirements.
Quantitative Detection
The VERSANT 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 HCV viral load assay, the VERSANT‰ 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 HCV genotype assay (LiPA)BM__ftnref2[2] 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 continued.
Bayer's nucleic acid portfolio for infectious disease also includes VERSANT‰ assays for hepatitis B virusBM__ftnref3[3] 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 sterilized.
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.
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 (www.bayerdiag.com), 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 developments.
BM__ftn1[1] 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.
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