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Roche Licenses PI3K Biomarker from Qiagen to Create PCR-Based Dx Assays for Rx Development

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By Ben Butkus

Roche said this week that it has obtained a worldwide license from Qiagen for the PI3K biomarker to develop real-time and endpoint PCR diagnostic assays on Roche's Cobas 4800 clinical laboratory system.

With the license in hand, Roche will develop assays for diagnostic markers to help subsidiary Genentech and external pharma partners to advance investigational drug candidates that inhibit PI3K.

The agreement also fits into Roche's strategy to build out "an extensive menu" of molecular tests for the Cobas 4800, which it launched late last year, Roche Molecular Diagnostics President and CEO Paul Brown told PCR Insider this week.

Under the terms of its agreement with Qiagen, Roche will have co-exclusive rights along with Qiagen to develop PCR-based diagnostic assays based on PI3K.

Roche and Qiagen "now share the license for PI3K," Thomas Theuringer, director of public relations for Qiagen wrote this week in an e-mail to PCR Insider.

"We have not shared it with any other company," Theuringer said. "The rights now obtained by Roche do not affect our own PI3K assay development and partnering program for new cancer drug candidates. In fact, given that mutations in this gene could be indicative for successful treatment of a number of different cancers, we think that this biomarker holds enough potential for both companies."

Theuringer also noted that sharing the license with Roche "generates additional royalty income for us," though he declined to elaborate. Financial details of the agreement have not been disclosed.

According to the American Association for Cancer Research, the PI3K pathway is mutated in more cancer patients than any other, and plays an important role in colorectal, gastric, breast, and endometrial cancers.

Patents covering PI3K mutations in human cancers are owned by Johns Hopkins University, which exclusively licensed the IP to Qiagen subsidiary DxS, now Qiagen Manchester, earlier this year (PCR Insider, 2/11/10).

At the time, Qiagen CEO Peer Schatz said that the company expects to develop assays based on the biomarker and shepherd them through the US and European regulatory processes; and that it has a PI3K assay development and partnering program with pharmaceutical companies such as AstraZeneca, Merck, Amgen, Lilly, Boehringer-Ingelheim, and Pfizer.

Qiagen also currently markets a research use-only test kit that detects four somatic mutations in the PI3K oncogene.

This week, Roche's Brown said that Roche will be pursuing separate assays and indications than Qiagen and its partners.

"We will be looking to work with pharma companies that are interested in this target —both our own internal organization in Genentech and Roche, but also working with external pharma partners," Brown said, without elaborating on potential partners.

Brown also said that the PI3K biomarker "falls into that same group with well-known targets that are very important, such as KRAS, EGFR, and BRAF. It’s a well-known target with the expectation that it will lead to good therapeutics.

"We’re looking to find diagnostic markers that can be used with therapeutics to treat patients in a variety of tumor types," he added. "It’s an important component of a personalized healthcare approach."

According to a report this week from PCR Insider sister publication PGx Reporter, Roche's Genentech currently has in its pipeline the PI3K inhibitor GDC-0941, which is in four Phase Ib clinical trials in HER2-positive metastatic breast cancer and metastatic non-small cell lung cancer; and the PI3K/mTOR inhibitor GDC-0980, currently in Phase I studies for several solid tumors and expected to enter into Phase II trials in ER-positive metastatic breast cancer patients in the first quarter of 2011.

Roche's PI3K assay will run on its Cobas 4800 clinical laboratory system, which combines the Cobas x 480 instrument for fully automated sample prep from primary sample tubes with the Cobas z 480 instrument for real-time PCR based amplification and detection.

The Cobas z 480 analyzer is the most advanced edition of Roche's LightCycler platform, and was specifically developed for in vitro diagnostic applications, offering faster amplification for higher throughput and superior fluorescence signal detection, according to the company.

Currently, the Cobas 4800, which Roche launched at the end of 2009 in Europe and Asia-Pacific, supports CE-marked IVD testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and human papillomavirus.

"The intention is we would put the [PI3K assay] onto the same platform and have an extensive menu on this platform, which is tried and trusted and already used for HPV and CT/NG in some parts of the world," Brown said.

He added that Roche is also working on EGFR and BRAF assays for the system.

Last week, Roche announced data from its "Addressing the Need for Advanced HPV Diagnostics," or ATHENA, trial in the US, supporting the ability of the Cobas 4800 HPV test to identify women with cervical pre-cancer missed by cytological examination with a Pap test (PCR Insider, 7/8/10).

Roche said that the test is currently under review by the US Food and Drug Administration and that pre-market approval is pending.

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