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Flu Testing Fuels Revenue Growth in Roche's PCR, Purification Business This Year

NEW YORK (GenomeWeb News) – Roche last week said that demand for influenza testing products drove a 24 percent spike in sales for its PCR and nucleic acid purification business in the first nine months of 2009.

Specifically, the company said that sales of its MagNA Pure nucleic acid sample-prep system and its LightCycler thermal cycler were the "biggest contributors" to growth in its Applied Science business, which reported an overall year-to-date revenue increase of 12 percent, to 616 million Swiss francs ($608 million). The firm does not break out sales revenues for its specific product lines.

Roche's Applied Science business contributed 8 percent to Roche Diagnostics' overall revenues of 7.4 billion Swiss francs during the period. Overall sales for the company, including the Pharmaceuticals and Diagnostics divisions, totaled 36.4 billion Swiss francs for the first nine months, an 11 percent increase over last year's revenues.

Growth in the qPCR and NAP business was "helped by strong demand for instruments and reagents for pandemic influenza testing and surveillance," Roche said. The company added that its RealTime Ready Influenza A/H1N1 test, which it launched for research use only in May, has generated "very strong sales."

Robertus van Miltenburg, global marketing director for qPCR & Nucleic Acid Purification systems at Roche Applied Science, told GenomeWeb Daily News this week that the firm has seen strong sales for the H1N1 test, reagents, and consumables, but "the biggest growth" has been in instruments.

He said that a "very substantial" portion of the 24 percent growth in qPCR and NAP systems could be attributed to H1N1.

The company in September submitted an emergency use authorization filing with the US Food and Drug Administration for the Pandemic (H1N1) 2009 test. Van Miltenburg said that Roche is currently in discussions with the agency regarding the EUA approval.

Looking forward, van Miltenburg said that Roche sees the greatest opportunity in its PCR and Nucleic Acid Purification business for higher-throughput systems that offer users more ease of use and improved integration.

In line with that strategy, the company recently launched several new products that are intended to give customers higher-throughput options. In September, Roche released the MagNA Pure 96, which enables batch processing of up to 96 samples in parallel in under an hour.

Van Miltenburg said that Roche is targeting the system also toward pharmaceutical customers who are increasingly using nucleic acid-based testing in drug development studies.

"More and more studies require pharmacogenomic and pharmacogenetic information to be gathered … and the MagNA Pure 96 is clearly positioned to help in this situation," he said.

The company began shipping the MagNA Pure 96 this month, and will ship more than 20 boxes in October, which is "quite a success" for an instrument of this type, he said.

Roche also launched a higher-throughput version of its LightCycler platform — the LightCycler 1536, which is building upon the LightCycler 480 platform architecture but uses a plate with 1,536 individual reaction wells. In addition to the expanded throughout of the system, van Miltenburg said that it enables smaller reaction volumes of between 0.5 microliters and 2 microliters.

And earlier this month, the company launched its RealTime Ready Configuration Portal, an online service that allows users to configure and order custom qPCR assays as single assays or pre-plated on microwell plates for human gene expression studies. The company intends to extend that to mouse and rat and other types of analysis in the future, van Miltenburg said.

The portal is envisioned as a "way of reducing complexity" in assay design, van Miltenburg said, "and enabling the customers to do more of these kinds of analyses on their own."

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