Healthcare giant Abbott Laboratories (ABT) Wednesday said that the U.S. Food and Drug Administration has approved the Abbott RealTime HBV assay. The test is used to measure the amount of hepatitis B virus or HBV in a patient's blood and is the first of its kind capable of automating HBV viral load testing from sample extraction to final results.
Abbott said that its RealTime HBV assay, which is based on real-time PCR or polymerase chain reaction technology, is now available for laboratories that use the company's m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement of the virus in human plasma or serum from chronically infected individuals.
According to the World Health Organization, hepatitis B is a serious public health problem. However, it is preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic or lifelong infections.
These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95% effective in preventing chronic infections from developing.
The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. It can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Test results must be interpreted within the context of all relevant clinical and lab findings.
However, the company noted that use of the test to determine the clinical stage of HBV infection has not been established. Also, it is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of the infection. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil.
"The Abbott RealTime HBV assay, which is the first and only automated HBV viral load test approved by the FDA, is an important tool for helping physicians make and adjust treatment decisions for newly diagnosed patients and those taking anti-viral medications," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The test will also help improve laboratory productivity by automating the most labor intensive steps of HBV testing."
The assay detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome. The capability for detecting HBV genotypes is important for both monitoring the disease and guiding treatment decisions.
In addition, it offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood. This is an important factor in helping physicians accurately assess a patient's response to therapy.
The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing. The m2000 is designed to detect viruses and bacteria in patient samples in less than six hours.
ABT is currently trading at $50.41, up $1.07 or 2.17%, on a volume of 2.30 million shares on the NYSE. In the after hours, the stock traded up $1.05 or 2.13%.
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