Navigation Links
Abbott's RealTime Hepatitis B Viral Load Test Receives CE Marking in Europe

Represents first and only molecular test capable of detecting and measuring all known forms of hepatitis B genotypes, providing a valuable tool for physicians in managing patient therapy.

Abbott and Celera, an Applera Corporation business, announced today that Abbott has received CE marking for a real-time PCR (polymerase chain reaction) test for monitoring hepatitis B (HBV) viral load in patients, allowing the test to be marketed in the European Union. Abbott is marketing the test under its strategic alliance with Celera.

The Abbott RealTime HBV test, developed for use on the Abbott m2000(TM) automated instrument system, is designed for the quantitation (precise measurement) of HBV in human plasma or serum from patients known to be infected with the virus. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing a patient's response to antiviral treatment. With the addition of the HBV test, the m2000 offers the broadest menu of molecular tests available on a single instrument platform. The m2000 menu includes real-time PCR tests for HIV-1, hepatitis C, chlamydia, and a combination test for chlamydia and gonorrhea.

Quantitative measurements of HBV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of patients with HBV. An initial measurement of HBV viral load can guide a decision to begin antiviral therapy, while monitoring HBV DNA levels during therapy can influence its duration and also signal the development of drug resistance.

In addition, the higher the baseline viral level the more likely a patient is to develop hepatocellular carcinoma, a primary cancer of the liver.

"The Abbott RealTime HBV assay is the only test currently available that targets an essential, highly conserved segment of the HBV genome, which makes it a very reliable test for detecting and measuring all known HBV genotypes," said John Robinson, Ph.D., senior director, research and development, Abbott Molecular. "It gives physicians one of the most precise tests available to guide treatment decisions and builds upon Abbott's 30-year legacy in hepatitis testing." HBV genomes have been classified into eight genotypes (A-H). Detecting HBV genotypes is important in terms of both monitoring the disease and guiding treatment decisions. For example, genotype C, which is prevalent in Asia, is considered to be associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in the Asia region) has a better prognosis, is rarely associated with hepatocellular carcinoma and seems to have a better response to certain antiviral therapies compared with genotype C.

The Abbott RealTime HBV assay has been developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to efficiently detect and measure life-threatening viruses and bacteria in patient serum or plasma samples in less than five hours, compared to other testing methods that may take up to two days. The RealTime HBV test is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.

Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera.

In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.

"We're very pleased that the menu for the m2000 system is expanding in Europe with the registration of the RealTime assay for monitoring hepatitis B viral load," said Kathy Ordonez, president, Celera. "The five tests now approved for sale in Europe on the m2000 system reinforce the system's breadth of menu as a competitive advantage." About Hepatitis B According to the World Health Organization, hepatitis B is a serious global public health problem, but 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 (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 percent effective in preventing chronic infections from developing. The prevalence of HBV infection and the method of transmission vary greatly around the world. 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 child to child during early childhood.

In areas of low prevalence, the infection is usually acquired during adulthood through intravenous drug use or high-risk sexual activity.




'"/>




Related medicine news :

1. Abbotts Humira(r) (Adalimumab) Gets Approval by EU for Crohns Disease Treatment
2. Vitamin B for Hepatitis
3. Hepatitis G May Boost HIV Survival
4. Cure for Hepatitis B
5. Hepatitis E virus made impotent
6. Sharing injection equipment spreads Hepatitis C
7. Lymphomas Link to Hepatitis C
8. Hepatitis shots is promising
9. Need for Hepatitis Booster Questioned
10. Good News for HIV Patients Also Suffering From Hepatitis C Virus
11. The Link Between Hepatitis B Vaccine And Multiple Sclerosis Questioned
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/4/2016)... ... 04, 2016 , ... Nike Rugby Camp's success is due in large part ... of Elite Rugby Camps and current Nike Camp director, has offered an all abilities ... , “I’m excited for our eighth summer here in San Diego,” says Willis. "We ...
(Date:5/4/2016)... ... 2016 , ... All-Star Insurance of Northeast TX has announced ... their local community. The agency pledges to select a new beneficiary every 60 ... bring awareness to important local causes with fundraising and other support, by forming ...
(Date:5/4/2016)... ... May 04, 2016 , ... Dr. Elyson and Dr. Assili, ... at their office. Wisdom tooth removal, a common dental procedure, is performed for many ... are improperly erupted, resulting in risks of complications. By providing wisdom tooth removal surgery ...
(Date:5/4/2016)... ... , ... Francesca Loparco, Co-Founder of Queen City Dream Cars, an exotic car ... procedure at Christenbury Eye Center. The entrepreneur struggled with her computer, riding horses ... day as her in-office consultation and eye exam. Francesca’s eyesight was restored to 20/20 ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... small and compact tactical (6.7 inch) dual-light flashlights in models NSP-9842XL and ... NSP-9842XL (average retail starting at $59.95) uses 2 included CR-123 batteries to produce ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... 3, 2016   Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that it is celebrating Hepatitis ... of two patients who tell their personal story and encourage those at risk to get ... Jacque: Hepatitis C ... ... Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.) ...
(Date:5/3/2016)... -- Forté Elements, LLC (Forté) is excited to announce the launch of its Mediceutical line ... of recovery for a variety of clinical conditions. Founded in 2013, Forté spent more ... Logo -  http://photos.prnewswire.com/prnh/20160502/362547LOGO ... ... ...
(Date:5/2/2016)... NEW YORK , May 2, 2016 /PRNewswire/ ... Series B financing of Graybug Vision, Inc. Graybug ... to developing therapies that may transform care for ... and glaucoma.  Graybug Vision,s technology was first developed ... out into a startup venture. ...
Breaking Medicine Technology: