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Roche PCR, Sample Prep Products Help Drive Applied Science Q1 Growth

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Roche today reported a 7 percent increase in first-quarter 2010 sales for its diagnostics division, which includes revenues from the company's instrumentation for sample preparation and PCR analysis, as well as PCR-based molecular diagnostics.

Overall, Roche said that its diagnostics division recorded first-quarter sales of CHF 2.52 billion ($2.38 billion), and said that the division's growth was "substantially ahead of the global market."

All five business areas within the diagnostics division — professional diagnostics, diabetes care, molecular diagnostics, applied science, and tissue diagnostics — saw an increase in sales, with professional diagnostics, diabetes care, and applied science the biggest contributors to growth.

In particular, Roche's applied science business, which contains its sample prep and PCR instrument platforms, reported the strongest growth in Q1, with a 15 percent spike to CHF 226 million. The applied science business unit contributed to 9 percent of overall sales in the diagnostics division.

Roche said that applied science growth was driven by strong demand, particularly in China, for its MagNA Pure sample prep platform and LightCycler quantitative PCR instrument. Taken together, sales of these platforms grew 39 percent year over year, Roche said.

In addition, the company's microarray business, also part of applied science, grew by almost 40 percent in the wake of the worldwide launch of the NimbleGen CGX-6 cytogenetics multiplex array for high-resolution analysis of chromosomal abnormalities.

Growth in these areas offset a 15 percent decline in sequencing sales in Q1 — the only product line within the applied science business unit to experience a decline.

The company's molecular diagnostics unit logged sales of CHF 294 million — essentially the same as Q1 2009, but a 2 percent increase when considering local currencies, the company said. The molecular diagnostics division comprised 12 percent of total diagnostics division sales.

Within this business unit, a slight decline in virology, which had a strong performance in Q1 2009 due to non-recurring instrument sales in Asia–Pacific, was offset by 8 percent growth in blood screening based on the addition of new customers.

The molecular diagnostics unit also sells the cobas 4800 system, which combines the cobas x 480 instrument for fully automated sample prep from primary sample tubes; and the cobas z 480 analyzer for real-time PCR based amplification and detection. The company said that "initial uptake … of the cobas 4800 system, launched at the end of 2009, has been very encouraging." Roche launched the cobas 4800 system late last year in Europe and Asia-Pacific.

The system's test menu currently comprises dual target tests for Chlamydia trachomatis and Neisseria gonorrhoeae, and a screening and genotyping test for human papillomavirus. The company released preliminary data from its "Addressing the Need for Advanced HPV Diagnostics," or ATHENA, trial in February, demonstrating the clinical utility of HPV genotyping in cervical cancer screening. Roche said that it will present full data from the ATHENA trial with the cobas 4800 HPV in July, and is planning a US regulatory filing for the test midyear.

Other planned molecular diagnostic product launches in 2010 include the LightCycler MRSA automated real-time PCR-based test for methicillin-resistant Staphylococcus aureus in the US in Q2; Cobas AmpliPrep/TaqMan tests for managing cytomegalovirus infection in solid organ transplant patients in Europe in Q3; and Cobas AmpliPrep/TaqMan tests for HIV-1 and hepatitis B virus in the US in Q4.

Roche's tissue diagnostics and professional diagnostics business units, both of which primarily contain immunochemistry-based products, saw 13 percent and 8 percent revenue growth, respectively; while its diabetes care unit reported 4 percent revenue growth.

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