Abbott Introduces Hepatitis B Sequencing Test in Europe
By Abbott, PRNEWednesday, March 30, 2011
WIESBADEN, Germany, March 31, 2011 - Abbott Molecular announced today that it has received CE Marking
(Conformite Europeene) to market the Abbott HBV Sequencing test in the
European Union. This molecular diagnostic test, developed to identify genomic
sequences of the hepatitis B virus (HBV) and help physicians monitor HBV
infections, guide treatment decisions, and predict or discover drug
resistance, is the first DNA sequencing assay developed and introduced by
Abbott Molecular.
The CE-Marked Abbott HBV Sequencing test identifies the DNA sequence of
the HBV polymerase gene including all clinically relevant HBV drug resistant
mutations. The test is not intended for screening blood donors, plasma or
tissue donors for HBV, or to be used as a diagnostic test to confirm the
presence of HBV infection.
HBV is classified into eight separate genotypes (labeled A-H). HBV
genotype is a prognostic indicator because it correlates with disease
severity and response to interferon therapy. For example, genotype C is
prevalent in Asia and associated with more severe liver disease and
development of liver cancer. In contrast, genotype B (also prevalent in Asia)
has a better prognosis and is rarely associated with progression to liver
cancer. Also, patients with HBV genotypes A and B seem to respond better to
interferon therapy than those with genotypes C and D.
Significant progress has occurred in recent years in developing antiviral
therapies for HBV. Several anti-polymerase drugs are available worldwide. The
new HBV Sequencing assay can be used in tandem with Abbott's RealTime HBV
viral load assay to monitor the efficacy of HBV treatments.
"The addition of the Abbott HBV Sequencing assay offers laboratories a
highly precise method for managing HBV patients. After assessing patient
viral loads, physicians can order the HBV Sequencing test to select or change
antiviral therapies based on known drug resistance of specific viral
genotypes," said Kristina Rodnikova, divisional vice president and general
manager of Abbott's molecular diagnostics business in Europe.
"The Abbott RealTime HBV viral load and HBV Sequencing assays are
examples of how molecular diagnostic technologies are helping clinicians
worldwide manage serious infectious diseases more precisely and effectively
through optimal utilization of antiviral drugs."
The Abbott HBV Sequencing assay was developed for use on the Life
Technologies ABI 3130 DNA sequencing system.
About Hepatitis B
A serious global public health problem, hepatitis B is an inflammatory
liver disease caused by the hepatitis B virus that results in liver cell
damage. The damage can lead to scarring of the liver (cirrhosis) and
increased risk of liver cancer.
Hepatitis B is preventable with safe and effective vaccines that have
been available since 1982, according to the World Health Organization (WHO).
But today some two billion people have been infected with the hepatitis B
virus, and more than 350 million are chronic carriers. In countries with a
high prevalence of chronic HBV infection, the most common route of infection
is from mother to child at birth or from young children infecting each other.
In areas of low prevalence, HBV usually is transmitted during adulthood from
intravenous drug use or high-risk sexual activity.
Ninety-five percent of adults infected with HBV develop antibodies and
recover within six months. Upon recovery, they develop immunity to the virus
and are not infectious to others. Those with chronic HBV infections are at
high risk for cirrhosis of the liver and liver cancer, which account for
about one million deaths every year.
About Abbott Molecular
Abbott Molecular, abbottmolecular.com, is an emerging leader in
molecular diagnostics - the analysis of DNA, RNA, and proteins at the
molecular level. Some of Abbott Molecular's tests are designed to detect
subtle but key changes in human genes and chromosomes. The results of these
tests may aid in the earlier detection or diagnosis of disease, may influence
the selection of appropriate therapies, and may improve monitoring of disease
progression.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
130 countries.
Abbott news releases and other information are available on the company's
Web site at www.abbott.com.
Media, Don Braakman of Abbott, +1-847-937-0080
Tags: Abbott, Germany, March 31, Wiesbaden