First Duplex Test for Parvovirus B19 and Hepatitis A Virus Now Available in the US
Pleasanton, California, 04. Februar 2011
cobas® TaqScreen DPX Test can detect two important pathogens in human plasma1
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the cobas® TaqScreen DPX Test for use on the cobas s 201 system is now available in the US. It is the first commercial test to quantify parvovirus B19 and detect hepatitis A virus (HAV) simultaneously in one assay in human plasma.
Human plasma is used to create treatments for life-threatening and chronic diseases and disorders such as hemophilia and primary immunodeficiency diseases. Plasma is also used to treat patients who have suffered severe burns or trauma and has many other therapeutic uses.
“The launch of this test is an important part of our strategy,” said Paul Brown, Head of Roche Molecular Diagnostics, “not only is it an important test for the continued safety of plasma products, but it also indicates our continued commitment to this vital area.”
The test is a state-of-the-art, in vitro nucleic acid amplification technology (NAT) test which offers complete coverage of all human genotypes of parvovirus B19 (genotypes 1, 2 and 3 DNA) and HAV (genotypes I, II and III RNA) in human plasma.
The cobas® TaqScreen DPX Test uses multi-dye, real-time polymerase chain reaction (PCR) technology which allows for the simultaneous detection and identification of individual viral targets without the use of additional discriminatory tests. A further innovative aspect of this test is that facilitates quantification of the parvovirus B19 while detecting extremely low levels of HAV.
Both parvovirus B19 and HAV are difficult to inactivate by traditional methods used by the plasma industry and there have been reports on the transmission of HAV and parvovirus B19 through blood and plasma products. Both parvovirus B19 and HAV in human plasma can be detected by NAT during the manufacturing process of plasma products, so improving the safety of these products.
About Roche Blood and Plasma Screening
Roche is a leader in the global NAT blood and plasma screening market, which is estimated at almost 900 million CHF. Nucleic acid-based tests enable earlier detection of active viral infections than conventional antibody or antigen assays. Roche’s real-time PCR-based nucleic acid assays have been used since 1998 to screen blood and plasma products. Currently, more than 225 blood banks worldwide use Roche’s automated cobas s 201 system.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management.
Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1) The cobas® TaqScreen DPX Test is not an FDA-licensed product.