FDA Approves First Hepatitis B Viral Load Test

�The U.S. Food & Drug
Administration (FDA) has approved the Roche COBAS(R) TaqMan(R) HBV Test,
the first assay for quantitating 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 may use viral load
testing results to establish a baseline level of infection and during
treatment as an assistance in assessing individual responses to therapy.
Widespread application program of antiviral therapy along with the Hepatitis B
vaccine has helped reduce prevalence; however, Hepatitis B remains a
serious and potentially life threatening global disease, potentially
resulting in death from extensive liver damage or liver malignant neoplastic disease for
chronically infected people.(1)



"Viral load examination with an FDA approved test has long been the
criterion 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 standardised viral encumbrance measurement to Hepatitis B
treatment."



Because the goal of Hepatitis B therapy is to treat until the virus is
undetectable in the patient's bloodline, it is critical for viral shipment
monitoring tests to be able to quantify selfsame low levels of virus.
Similarly, it is of import for the test to quantify identical high levels of
virus (higher than 100 meg IU/mL), an indicator of the need for more or
less aggressive treatment. The Roche COBAS(R) TaqMan(R) HBV Test can notice
the World Health Organization (WHO) HBV International Standard in plasma
and blood serum as low as 3.5 IU/mL and 3.4 IU/mL respectively. The test lavatory
measure HBV DNA as high as 1.10E8 IU/mL, representing a importantly
broader dynamic range than previously uncommitted tests in the U.S.



Other infections concomitant with Hepatitis B are common, with up to
10% of HIV patients in the US also septic with Hepatitis B virus. This
makes it essential for the test to quantitate the HBV virus in presence of
other viruses.



Designed for manipulation with the High Pure System, the test is run on the
COBAS(R) TaqMan(R) 48 analyzer and gives labs the added benefits of
automated real time PCR. The test system benefits from the same
contamination control protection intentional into all COBAS(R) TaqMan(R)
assays, including closed-tube processing and integral Roche-proprietary
AmpErase enzymes. To help with needed standardization, the Roche COBAS(R)
TaqMan(R) HBV Test has been calibrated with the WHO standard and reports
with the international unit of measure IU/mL. The quiz was designed to
quantify all major Hepatitis B genotypes, including pre-core mutants that
can lead to more