By Ron Shinkman, Editor, Laboratory Industry Report
Pharmaceutical and testing giant Roche has submitted to the U.S. Food and Drug Administration a companion diagnostic for non-small cell lung cancer.
The assay, known as the cobas EGFR mutation test, would be used in conjunction with an AstraZeneca investigational therapy for lung cancer patients with an acquired mutation for resistance.
"The collaboration with AstraZeneca to be the companion diagnostic for their third generation EGFR drug therapy is a testament to the innovation and quality of Roche oncology assays and demonstrates the value of molecular testing in patients," said Paul Brown, who heads Roche’s molecular diagnostics division, in a statement.
The test is a variation on an already market-approved test that identifies a variety of EGFR mutations in lung cancer patients. This test can focus on the T790M mutation, which represents about two-thirds of all cases of resistance to more common forms of medication for lung cancer.
About 221,000 new cases of lung cancer are diagnosed in the United States every year. It is among the most deadly of cancers, killing about 158,000 annually.
“The partnership with Roche on developing a companion diagnostics test for AZD9291, ensures that physicians will be able to identify the patients most likely to benefit from the treatment," said Antoine Yver, head of oncology and global medicines development at AstraZeneca, in a statement.