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Qiagen and Roche Report Spike in MDx Revenues for FY 2010

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Qiagen and Roche this week each reported spikes in molecular diagnostics sales in 2010, although Roche reported flat sales for its applied science group.

For the fourth quarter of 2010, Qiagen's molecular diagnostics sales increased 7 percent on a constant exchange rate basis over 2009, primarily due to its infectious disease testing portfolio. Meantime, full-year 2010 molecular diagnostics sales rose 14 percent on a constant exchange rate basis over 2009. Qiagen said that molecular diagnostics comprises 48 percent of the company's total sales.

The company noted that a key 2010 molecular diagnostics milestone was the European launch of QIAsymphony RGQ, the company's modular instrument platform that automates entire laboratory workflows from sample preparation to final result; and allows customers to run commercial molecular diagnostic assays and to develop and conduct their own PCR-based tests (PCR Insider, 9/1/10).

Qiagen said that the US introduction of QIAsymphony RGQ, planned for early this year, will be accompanied by an extensive development program involving more than 10 molecular assays. Specifically, it said that in 2011 it plans to submit for regulatory approval assays for cytomegalovirus, Epstein-Barr virus, and influenza.

Also in 2011, the company will initiate assay development programs in the areas of HIV-1, hepatitis B, and hepatitis C. Qiagen gained access to the HIV-1 and HCV tests through an agreement with Abbott inked in October.

Overall, Qiagen's total fourth-quarter revenues declined 1 percent to $286 million for the three-month period ended Dec. 31, compared to $289.1 million for the fourth quarter of 2009.

Qiagen posted net income of $36.3 million, or $.15 per share, compared to $44.5 million, or $.18 per share, for Q4 2009. The firm's R&D spending for the quarter was $34 million, up 11 percent from $30.6 million, and its SG&A spending was down around 9 percent at $98.6 million from $108.7 million.

For full-year 2010, Qiagen had revenues of $1.09 billion, up 8 percent from $1.01 billion in 2009.

In other business segments, revenues for Qiagen's applied testing division (6 percent of total sales) grew 5 percent in Q4 and 22 percent for the full year over the comparable periods in 2009. Meantime, sales of pharmaceutical research products (21 percent of total sales) rose 11 percent in Q4 and 9 percent for the full year; while receipts from academic research products (25 percent of total sales) achieved a 5 percent increase in Q4 and 10 percent growth full-year.

Also this week, Roche reported that its 2010 molecular diagnostics sales were up 1 percent over fiscal-year 2009 while applied science sales remained flat year over year.

Molecular diagnostics and applied science are two of five groups within Roche Diagnostics. Molecular diagnostics includes revenues from the company's PCR-based molecular diagnostics, while applied science includes revenues from instrumentation for sample preparation and PCR analysis.

Roche's molecular diagnostics group reported sales of CHF 1.19 billion ($1.27 billion) for 2010, up from CHF 1.18 billion in 2009. Sales for its applied science business, which includes its sample prep, PCR, sequencing, cell analysis, and microarray products, were roughly flat at CHF 868 million compared to CHF 870 million for 2009.

Roche said that its virology products were the main growth driver for the year; and that demand for its Cobas 4800 molecular diagnostics system was strong, with "good growth" in North America and steady sales in the European Union.

Roche noted that it filed for US Food and Drug Administration clearance during 2010 for its HPV molecular assay and expects to receive marketing approval in the second half of this year (PCR Insider, 7/22/10).

Meantime, Roche said that applied science sales were driven by cell analysis, genomics, and custom biotech products. However, sales of its MagNA Pure sample preparation product and LightCycler PCR product line declined year over year due to "dramatically lower demand" for influenza A (H1N1) virus testing, the company said.

Overall, Roche Diagnostics had sales of CHF 10.42 billion, up 4 percent from CHF 10.10 billion for 2009. The division also reported a cash operating profit of CHF 2.2 billion, an increase of 26 percent over 2009.

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