This marks the first companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations to be approved by the U.S. Food and Drug Administration, the agency said. The diagnostic is called the Cobas EGFR Mutation Test.
"Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient," Alberto Gutierrez, of the FDA's Center for Devices and Radiological Health, said in a statement.
The approval will also move Tarceva up the treatment chain for those patients who test positive for the EGFR mutation. The drug was originally approved in patients with advanced non-small cell lung cancer only after they were not helped by at least one previous chemotherapy regimen.
"People with this type of lung cancer now have the option to use a personalized medicine as their initial treatment to help them live longer without their disease worsening," Hal Barron, chief medical officer of Roche Holding Ag's Genentech unit, said in a statement.
(Reporting by Bill Berkrot; Editing by Carol Bishopric)