Research Study Characterized Analytical Performance and Clinical Potential of Roche Flu Test

Penzberg, (PresseBox) - The availability of suitable diagnostic tools for identifying infected individuals is crucial for precise treatment in infectious diseases. The appearance of a novel pandemic human strain of Influenza A (H1N1/09) in April 2009, which is currently regarded as the most dangerous widespread influenza virus subtype, may serve as an example. Surveillance and early disease containment measures continue to play an important role in managing outbreaks of this virus. According to the WHO Influenza update(1) of February 25, 2011, influenza activity is increasing in parts of North America coincident with increasing numbers of detections of Influenza A(H1N1) 2009 and influenza type B. The dominant virus in North America is still currently Influenza A (H3N2). Transmission of influenza appears to have peaked in most parts of Western Europe, with the number of severe and fatal cases continuing to accumulate.

During 2009/2010, the RealTime ready Influenza A/H1N1 Detection Set from Roche Applied Science (SIX: RO, ROG; OTCQX: RHHBY) proved its suitability for identifying individuals suffering from Influenza A (H1N1)/2009, by helping physicians determine an early, targeted treatment for this group. In a recent research study (2), the analytical performance and clinical potential generated with the RealTime ready Influenza A/H1N1 Detection Set using the LightCycler® 2.0 Instrument was further characterized. The study demonstrated the usefulness of the set as a tool for quickly detecting and monitoring H1N1/09 influenza A virus infections, which are known to cause more severe illness than the H3N2 und Inf B subtypes. According to the WHO, severe cases of infection occur in 15 - 64 year olds. A substantial number of cases appear outside of the known higher risk groups and a majority of these are due to (H1N1) 2009 virus infection.

"We have extended our RealTime ready Influenza portfolio in 2010 to be well prepared for a potential new pandemic outbreak in future," states Gerd Haberhausen, Life Cycler Leader qPCR at Roche Applied Science. "It allows identification of individuals infected with H1N1/09 influenza A virus and Influenza B, further improving the tests' potential to facilitate clinical decision making and demonstrating our commitment to Roche's Personalized Healthcare approach."

In late 2010, Roche Applied Science launched two new RT-PCR detection sets for Influenza B that can be used in a stand-alone reaction to detect Influenza B infections in a variety of research sample materials. In addition, the Inf B test supplements the previously launched RealTime ready Influenza A/H1N1 Detection Set, allowing researchers to perform duplex (LightCycler® 2.0) or triplex (LightCycler® 480) reactions for identifying and distinguishing between Inf A and/or Inf B infections. If the first test is positive for Inf A, users of this set can then test for the H1N1 subtype.

(1) http://www.who.int/...

(2) Wenzel et al. (2010) J. Clin. Microbiol. doi:10.1128/JCM.00785-10, http://jcm.asm.org/...

Roche Diagnostics Deutschland GmbH

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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