New Cancer Diagnostic Test Enters the Market

Posted by The Evidence Blog on June 9, 2015

The field of pharmacogenomics, the study of how genes affect an individual’s response to medications, continues to move full speed ahead, especially in oncology. As investigators learn more about the genetic changes that occur in cancer cells and factors that make them grow and survive, they have been able to develop therapeutic agents that target these factors as well as the tumor’s specific genetic makeup. Targeted therapies are options in several different types of cancer, including lung cancer, melanoma, leukemia, and colorectal cancer.

To identify patients with cancer who may benefit from targeted therapies, physicians need to be able to peer into the molecular components of a tumor and detect genetic variations. Roche’s KRAS Mutation Test, which gained approval last week from the U.S. Food and Drug Administration, does just that. Approved for diagnostic use in patients with metastatic colorectal cancer, the KRAS Mutation Test is designed to detect genetic variants on a specific section of the KRAS gene. In clinical practice, oncologists will use the test to identify patients who may be candidates for treatment with targeted therapies.

The KRAS Mutation Test is one of several FDA-approved companion diagnostics that have been developed in oncology to gather information about the molecular makeup of tumors. Once this information is known, patients and their physicians can make informed decisions about targeted cancer therapies that will, ideally, lead to increased survival.

Want more information about companion diagnostic tests? The Hayes Genetic Test Evaluation Program has reports and genetic testing algorithms available on several different cancer diagnostic tests. Hayes clients can visit the Knowledge Center to learn more. If you are not a client, call us for more information at 215.855.0615.

Topics: Hayes Blog, Genetic Testing

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