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Qiagen Continues Building PCR-Based Molecular Dx Menu with Johns Hopkins, Celera Deals

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Qiagen this week inked a pair of deals intended to bolster its rapidly expanding portfolio of molecular diagnostic offerings.

In the first deal, announced earlier this week, Qiagen said that its recently acquired DxS subsidiary has obtained a worldwide exclusive license from Johns Hopkins University to develop real-time and endpoint PCR companion diagnostic assays based on the PI3K biomarker.

Under the second deal, announced today by Celera, Qiagen will distribute a Celera multiplex PCR-based assay for detecting respiratory pathogens.

The financial details of the agreements were not disclosed.

In a conference call this week discussing the company's fourth-quarter and full-year 2009 earnings, Qiagen CEO Peer Schatz told investors that Qiagen's licensing agreement with Johns Hopkins "was a nice example" of the kinds of deals the company will be seeking in the future to build out the menu of diagnostic tests available on its sample prep and PCR instrument platforms.

Research has shown that variation in the PI3K gene could be a key biomarker for use as a companion diagnostic with certain cancer treatments, particularly lung, breast, and colorectal cancers.

During the conference call, Schatz called PI3K a "very important companion diagnostic candidate associated with a number of cancers … and as such [Qiagen] expects to be taking the assay forward to the [US Food and Drug Administration] pre-market approval and CE [Mark] stages."

Qiagen said that it has an active PI3K assay development and partnering program with pharmaceutical companies, including AstraZeneca, Merck, Amgen, Lilly, Boehringer-Ingelheim, and Pfizer, to develop and market tests for new cancer drug candidates.

The company also already markets a real-time PCR-based PI3K test for research use.

The patent for PI3K mutations in human cancers was initially filed internationally and in the US by Johns Hopkins researchers including Yardena Samuels, Victor Velculescu, Kenneth Kinzler, and Bert Vogelstein, who assessed the biomarker during their evaluation of tyrosine kinase inhibitors targeting the epidermal growth factor receptor pathway.

In its deal with Celera, announced today, Qiagen will distribute a Celera assay that it calls the next-generation version of Qiagen's ResPlex II multiplex PCR-based assay for detection of respiratory pathogens.

Multiplex assays allow testing for a multiple number of different pathogens in a single run. Qiagen originally developed the ResPlex II panel to detect respiratory viral RNA from influenza and parainfluenza viruses, respiratory syncytial virus, metapneumovirus, and rhinoviruses.

The new ResPlex assay detects 19 different pathogens associated with respiratory infections and is designed for use with Luminex's LiquiChip 100 and 200 instrument platforms, Celera said.

Under the agreement, Qiagen has exclusive worldwide rights to distribute the test kit, which will be manufactured by Celera. The new ResPlex kits will be available through Qiagen's existing sales channels, and will be submitted for regulatory approval in the United States and Europe, Celera said.

"Celera’s significant experience in the development and manufacturing of molecular diagnostic products is a very valuable resource and this relationship can accelerate our effort to further expand our molecular diagnostic solution portfolio," Schatz said in a statement. "We believe that this new product has the potential to provide significant value for laboratories, healthcare professionals, and patients worldwide."

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