FDA approves first hepatitis B viral Load Test on 2007

FDA approves first hepatitis B viral Load Test

Another Roche first in TaqMan real-time PCR testing for the diagnostic lab

The U.S. Food & Drug Administration (FDA) have approved the Roche cobas TAQMANHBV Test, the first assay for Quantitatin G hepatitis B virus DNA approved in the U.S. The test uses Roche ' s real-time PCR technology to quantify the amount of hepatitis B virus DNA in a patient ' s blood. Doctors viral load testing results to establish a baseline level of infection and during treatment as an aid in as Sessing individual responses to therapy.
Widespread application of antiviral therapy along with the hepatitis B vaccine have helped reduce prevalence; However, hepatitis B remains a serious and potentially life threatening global disease, potentially resulting in death fro M extensive liver damage or liver cancer for chronically infected people.1

Viral load testing with an FDA approved test have long been the standard for managing patients with HIV and hepatitis C , "said Teresa Wright, M.D, chief Medical Officer at Roche Molecular Diagnostics. "Availability of this new Roche test enables doctors and laboratories to bring that same level of standardized viral load Measurement to hepatitis B treatment. "

Because The goal of hepatitis B therapy is to treat until the virus are undetectable in the patient ' s blood, it's criti Cal for viral load monitoring tests to being able to quantify very low levels of virus. Similarly, it's important for the test to quantify very high levels of virus (higher than, million iu/ml), an Indicato R of the need for more or less aggressive treatment. The Roche COBAS TAQMAN HBV Test can detect the World Health Organization (WHO) HBV International standard in PLA SMA and serum as low as 3.5 iu/ml and 3.4 iu/ml respectively. The test can measure HBV DNA as high as 1.10E8 iu/ml, representing a significantly broader dynamic range than previously a vailable tests in the U.S.
other infections concomitant with hepatitis B is common, with up to 10% of HIV patients in The US also infected with hepatitis B virus. This makes it essential for the test to quantitate the HBV virus in presence of other viruses.

Designed for use with the high Pure System, the test was run on the Cobas taqman 48 Analyzer and gives labs th E added benefits of automated real-time PCR. The test system benefits from the same contamination control protection designed to all cobastaqman assays, Includi NG Closed-tube processing and built-in roche-proprietary amperase enzymes. To help with needed standardization, the Roche COBAS TAQMANHBV Test have been calibrated with the WHO standard and rep Orts with the international unit of measure iu/ml. The test was designed to quantify all major hepatitis B genotypes, including Pre-core mutants so can leads to more severe Liver disease and reduced response to antiviral therapy.

Roche Diagnostics, a leader in molecular diagnostics, had more than ten years of global experience in HBV viral load tes Ting and has actively monitored virus mutation through their Global surveillance program. The COBAS TAQMAN HBV Test is the latest in a portfolio of increasingly automated real-time PCR hepatitis and HIV Tests that Roche are developing the company's fully automated, real-time HIV monitor test was approved by the FDA in May 2 007 and the company have filed a premarket Approval application for their test to quantitate HCV virus RNA.

About hepatitis B
According to the World Health Organization, HBV are the most serious type of viral hepatitis infecting 2 billion people EAC H year and representing a serious public health problem. Even with a hepatitis B vaccine, which have been available since 1982, the U.S. Centers for disease Control estimates that 1.25 million people is living with chronic hepatitis B infection. Another 60,000 people become newly infected each year and 5,000 people die from hepatitis b-related complications.

The hepatitis B virus is spread through have unprotected sex, by sharing drugs, needles, or from a infected mother to H Er baby during birth. Symptoms occur in about percent of patients which include jaundice, fatigue, abdominal pain, loss of appetite, nausea, and vomiting.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche are one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and a innovator of products and services for the early detection, prevention, DIAG Nosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people ' s health and quality of life. Roche are the world leader in In-vitro diagnostics and drugs for cancer and transplantation, and are a market leader in Viro Logy. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and D Iseases of the central nervous system. In sales by the pharmaceuticals division totalled 36.8 billion Swiss francs, and the diagnostics division posted Sale S of 9.3 billion francs. Roche has R/r agreements and strategic alliances with numerous partners, including majority ownership interests in Gen Entech and Chugai, and InvesteD over 8 billion Swiss francs in R 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

1 U.S. Centers for Disease Control. Http://www.cdc.gov

For further information:
Jessica Brillant
Molecular Diagnostics Communications
phone:925.730.8503

Melinda Baker
Roche Molecular Diagnostics
Communications
phone:925-730-8379

FDA approves first hepatitis B viral Load Test on 2007