Public Release: 

IASLC pleased by FDA approval of blood test to detect mutations in lung cancer

Less invasive test a step forward for personalized medicine

International Association for the Study of Lung Cancer

DENVER - The International Association for the Study of Lung Cancer (IASLC) praises the U.S. Food and Drug Administration's (FDA) decision to approve the first blood test to detect an oncogenic driver mutation in non-small cell lung cancer (NSCLC). This marks a significant step forward in lung cancer treatment. The cobas EGFR Mutation Test v2 detects epidermal growth factor receptor (EGFR) gene mutations and the FDA approved a blood-based companion diagnostic for the EGFR tyrosine kinase inhibitor erlotinib (Tarceva).

Lung cancer is the leading cause of cancer-related deaths among men and women in the U.S. and around the world. According to the National Cancer Institute, U.S. doctors will diagnose an estimated 221,200 with lung cancer this year, and 158,040 will succumb to the disease. Lung cancer tumors can shed DNA into a patient's blood which means that testing a blood sample, sometimes called a "liquid biopsy," may detect specific mutations within the shed DNA.

Health providers perform most genetic tests for NSCLC through lung tissue samples. These procedures can be invasive and difficult for patients. A reliable blood test could replace the need for direct tissue samples. This new test may provide additional benefit to patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing. Current screening methods find EGFR mutations in approximately 10-20 percent of Caucasian NSCLC patients and more than 50 percent of Asian NSCLC patients, making it a promising target for precision therapy treatments.

"This is another example of how lung cancer serves as a role model for precision medicine. The rapid pace of scientific advances in the disease's treatment allows for new and novel therapies," said Fred R. Hirsch, MD, PhD, Professor of Medicine and Pathology at the University of Colorado Cancer Center and School of Medicine, and CEO of the IASLC. "This new and less invasive test gives patients and their doctors more options to more effectively diagnose and treat lung cancer. It is our hope that we can perform many more genetic tests through blood samples in the future."

Doctors have used erlotinib to help lung cancer patients for more than 10 years. The FDA first approved it in 2004 to treat patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen. In 2013, the FDA approved erlotinib for first-line treatment of patients with metastatic NSCLC whose tumors harbor EGFR exon 19 deletions or L858R substitution mutations as detected by an FDA-approved test.


Read the FDA's news release about the approval:

About the IASLC

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. Visit for more information.

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