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Clarient Licenses Biomarker IP from Insight Genetics

NEW YORK (GenomeWeb News) – Clarient Diagnostic Services today said that it has licensed worldwide rights from Insight Genetics to intellectual property covering the anaplastic lymphoma kinase biomarker.

Clarient, which is part of GE Healthcare, said that it intends to develop a quantitative PCR-based test to detect increased transcription of the anaplastic lymphoma kinase gene, which has been implicated in non-small cell lung cancer. Several ALK inhibitors are currently in clinical trials, and one drug, Pfizer's Xalkori (crizotinib), has already received approval from the US Food and Drug Administration.

Clarient's test would be the latest in a growing number of companion diagnostics targeting the ALK biomarker.

Last summer, Abbott received FDA clearance for its Vysis ALK Break Apart FISH Probe as a companion diagnostic for Xalkori. In addition, Pfizer has a deal with Roche's Ventana Medical Systems to develop an automated, immunohistochemistry test for determining which non-small cell lung cancer patients will respond to Xalkori.

"The National Comprehensive Cancer Network guidelines now suggest ALK testing as a standard measure for all non-small cell lung cancer patients due to the development of therapies targeting ALK inhibition," Clarient Chief Medical Officer Kenneth Bloom said in a statement. "Our agreement with Insight Genetics is another example of our mission of translating biomarker discovery to aid the development of new therapeutics and to assist physicians in determining the eligibility of their patients to receive the most appropriate therapy."

In addition to its role in lung cancer, ALK is believed to play a role in other cancers including diffuse large B-cell lymphoma, inflammatory myofibroblastic tumor, esophageal squamous cell carcinoma, colorectal cancer, and breast cancer. In total, 250,000 new cancer diagnoses in the US each year are believed to be linked to ALK mutations and fusions, the firms said.

Financial and other terms of the licensing agreement were not disclosed.

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