The Roche cobas® EGFR Mutation Test v2 is the first blood-based test approved for clinical use in the U.S. to detect certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients.

LabCorp played a key role in making the test available upon approval by the U.S. Food and Drug Administration (FDA) and is the only national laboratory currently offering the test.

"The availability of this test demonstrates LabCorp’s industry-leading position in the commercialization of companion diagnostics," said David P. King, chairman and chief executive officer of LabCorp.

"The success and growth of our companion diagnostics business continues to differentiate us from our competitors as we carry out our mission to improve health and improve lives."

The cobas® EGFR Mutation Test v2, which was approved by the FDA on June 1, 2016, can be used on either plasma obtained from a routine blood collection or on tumor tissue obtained from a surgical biopsy.

The test identifies epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations in patients with NSCLC who may benefit from first-line treatment with Tarceva.

The availability of a less-invasive, blood-based test gives physicians a powerful new treatment option for patients who may not be able to undergo surgical biopsy or who cannot provide a tumor specimen for other reasons.
"The FDA approval of the cobas® EGFR Mutation Test v2 for plasma-based testing offers a minimally invasive option for patients with NSCLC," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "Partnering with key labs ensures that patients can be tested conveniently."

"LabCorp is pleased to add this important new test to our menu of world-class diagnostics," said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. "Knowledge is power for patients and their physicians, and tests like this can help patients access targeted, personalized treatment."

Lung cancer is the leading cause of cancer death in the U.S. among both men and women, accounting for about one-third of all cancer deaths, more than the other common cancers combined (breast, prostate and colon cancers). More than 80% of all lung cancers in the US are NSCLC, and 10%-20% of these have EGFR mutations.

The cobas® EGFR Mutation Test v2 is now available for patient testing nationwide from LabCorp and Integrated Oncology, a member of the LabCorp Specialty Testing Group.

Tarceva is developed and commercialized by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.