By Molika Ashford

Genoptix, the medical laboratory within Novartis's molecular diagnostics unit, has launched a targeted sequencing-based test for mutations in BRAF, NRAS, and c-KIT to help physicians tailor treatment for metastatic melanoma patients.

The NexCourse Melanoma sequencing profile, offered through Genoptix's CLIA lab, is the company's first sequencing-based test service and is already being ordered by physicians, according to the firm. Genoptix's President Tina Nova declined to provide details on how the test is being used so far but did tell PGx Reporter in an e-mail that the panel is not being used to place patients into clinical trials for Novartis drugs.

The company sees the service as a tool to help inform treatment decisions for patients with metastatic melanoma by screening for clinically relevant mutations in three genes associated with different prognoses and potential responses to targeted treatments.

However, the NGS profile is "not intended as a test for any specific drugs;" is not linked to any drugs in Novartis' pipeline targeting BRAF, NRAS or c-KIT mutations; and the company is not using the NGS profile to place patients into clinical trials involving drugs in development, "nor do we have any plans to do so," Nova wrote.

And although the service will assess BRAF mutations including V600E and V600K mutations it is not intended to guide treatment with Roches Zelboraf, which is indicated for BRAF V600E mutation-positive metastatic melanoma. The US Food and Drug Administration approved the drug in August alongside Roche's internally developed companion test, the Cobas 4800 BRAF V600 Mutation Test.

"Our focus in Genoptix is on providing physicians with the most relevant clinical information. We believe that NGS technology is going to factor heavily in the diagnosis and treatment of patients in the future," Nova said.

Novartis acquired Genoptix in January 2011 and the business falls within Novartis Molecular Diagnostics, a unit formed around three years ago. The primary focus of the Novartis MDx business is companion diagnostics, but the company is also pursuing a "complementary diagnostics" strategy, which includes tests that don't require extensive coordination between drug and diagnostic development arms or simultaneous drug/test approval by the FDA (PGx Reporter 12/7/2011).

Nova did not detail Genoptixs hopes for the testing service beyond offering a more comprehensive test than currently available single-gene assays to help physicians tailor treatment for each patient.

"The NGS profile provides us with a much more comprehensive picture of the tumor than with assays that target specific point mutations, she said.

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Genoptix Says NGS Melanoma Test Will Not Be Used to Place Patients in Trials for Parent Novartis