Cancer double-team

Novartis, Pathwork Diagnostics forge collaboration to develop and sell diagnostics

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REDWOOD CITY, Calif.—Novartis AG and Pathwork Diagnostics Inc. have entered into a research collaboration to discover molecular diagnostics for cancer. Pathwork will work with Novartis' new molecular diagnostics unit to discover biomarker signatures that can serve as the basis for diagnostics across a range of tumor types.

Under the agreement, both companies have the right to develop and sell diagnostics, but they could extend this alliance, or form a second one, to advance products jointly. Financial terms of the deal have not been disclosed.

"There is no question that the future of cancer treatment will require and depend on molecular diagnostics," says Dr. Richard Klausner, former director of the National Cancer Institute and member of Pathwork Diagnostics' board of directors. "The collaboration between Pathwork and Novartis has the potential to yield diagnostic products that improve the quality of cancer care worldwide."

Pathwork, which has launched a molecular test that pinpoints the source of tumors of unclear origin, has fielded interest from multiple drug companies, says Chief Commercial Officer David Craford, but this is its first pharmaceutical alliance. As Pathworks builds its product pipeline with tests to predict cancer recurrence or drug response, Craford says it made sense to partner with Novartis, an industry leader with a strong oncology business. Craford says the collaboration will leverage Pathwork's industry leading informatics and proprietary method for discovering expression biomarker signatures in formalin fixed paraffin embedded (FFPE) tissue.

Pathwork's test uses a microarray system to measure expression patterns of about 2,000 genes. The results are compared with a database of known tumor types. One benefit of knowing where a tumor originated is that physicians can prescribe newer, molecularly targeted drugs that are approved for specific types of cancer, he says.

Mike Nohaile, head of Novartis Molecular Diagnostics, says Pathwork Diagnostics' robust biochip platform, cutting edge bioinformatics capabilities and large database of samples fit well into the strategies of both NIBR and Novartis MDx.

"We believe that Pathwork can help us to identify biomarkers which may support the development of innovative tests to provide physicians and patients with better information to guide treatment decisions and optimize patient outcomes," he says.

While alliances between pharmaceutical and diagnostics companies haven't been common, that could change as drugmakers seek ways to capitalize on advances making it possible to use biomarkers to match patients with the right medicines.

Craford adds that molecular diagnostics also can have a great impact on the future of cancer treatment.

"The American Cancer Society estimates that there are 1.4 million new cancer diagnoses annually in the United States," he notes. "Of these new cases, up to 10 percent are hard to classify using the patient clinical history and current diagnostic techniques. These cases may be metastatic undifferentiated or poorly differentiated tumors and are among the most frustrating for pathologists to diagnose and for oncologists to treat. These difficult cases place a disproportionate burden on patients, healthcare professionals and the healthcare system."

Pathwork's Tissue of Origin test can help diagnose these cancers. Craford explains that it is a molecular test that generates a RNA profile for a patient's tumor specimen, then compares it to a database of profiles and provides a report.

"The report provides information on the type of tissue present in the patient specimen and is used by the Pathologist to provide the cancer diagnosis," he says. "The FDA cleared the version of the test that works on FFPE specimens, the common solid tumor specimen type, in June."

The agreement with Pathwork Diagnostics is the second commercial partnership for Novartis' molecular diagnostics group, which struck a deal with Orion Genomics LLC in October to discover new epigenetic biomarkers.

Nohaile points out that the research agreement is looking specifically at gene expression in tumors to identify pathways to discover biomarker signatures.

"Pathwork will perform studies in specific biologic pathways to discover biomarker signatures which may be used in clinical studies/trials with Novartis compounds, or eventually used to develop commercial diagnostic tests," he says. "However, the research could potentially lead to utility in other therapeutic areas."

Nohaile adds that the agreement is an early-stage discovery agreement, "but we are optimistic that this will lead to innovative advances in guiding treatment to optimize patient outcomes. However, it is too soon to comment on its impact on Novartis' pipeline at this time."

Novartis launched its molecular diagnostics unit in late 2008 to identify companion tests that could be used with specific pharmaceuticals, and to develop standalone diagnostics that improve clinical decision-making. It is looking into alliances with many types of companies, notes Nohaile.

"It's quite a broad array of capabilities [that are] needed to create a diagnostic," Nohaile says. "We're interested in all of those areas."

Craford concludes that the collaboration between Pathwork and Novartis has the potential to "yield diagnostic products that improve the quality of cancer care worldwide."
"Our goal is to discover biomarker signatures that can serve as the basis for diagnostics across a range of tumor types," he says. "We expect to see results of this collaboration over the next few years."

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