FDA approves first blood test to detect genetic mutation associated with lung cancer

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Yesterday, the U.S. Food and Drug Administration approved the first blood-based genetic test that can detect gene mutations in non-small cell lung cancer patients.

The cobas EGFR Mutation Test v2 is a blood-based companion diagnostic for the cancer drug Tarceva. The test detects mutated DNA that has been shed from a non-small cell tumor into a patient's blood stream. These gene mutations are present in approximately 10-20 percent of non-small cell lung cancer patients.

Detection of the mutations helps inform which patients should be treated with Tarceva. If mutations are not found in the patient's blood, then a tumor biopsy must be performed to determine if non-small cell lung cancer mutations are present. Therefore, the blood test benefits patients who are too ill or otherwise unable to provide a tumor specimen for non-small cell testing.

"Approvals of liquid biopsy tests make it possible to deliver highly individualized healthcare for patients. [They] also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

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