US-based healthcare diagnostics company LabCorp has introduced a new application for the companion diagnostic to the use of Tarceva to treat non-small cell lung cancer (NSCLC).
The Roche cobas EGFR Mutation Test v2 is a blood-based, less-invasive test which detects certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients.
The company has assisted in making the test available following the approval by the US Food and Drug Administration (FDA) and is the only national laboratory offering the test.
The cobas EGFR Mutation Test v2 can be used on either plasma derived from a routine blood collection or on tumour tissue derived from a surgical biopsy.
It determines EGFR exon 19 deletion or exon 21 (L858R) substitution mutations in patients with NSCLC who can be responsive to a Tarceva first-line treatment.
Tarceva acts as the EGFR inhibitor and is used for NSCLC patients whose cancer has spread throughout the body and displays EGFR mutations.
The availability of the test offers a treatment option for patients who can’t undergo surgical biopsy or can’t provide a tumour specimen.
Roche Molecular Diagnostics head Uwe Oberlaender said: "The FDA approval of the cobas EGFR Mutation Test v2 for plasma-based testing offers a minimally invasive option for patients with NSCLC.
"Partnering with key labs ensures that patients can be tested conveniently."
Currently, the cobas EGFR Mutation Test v2 is made available for patient testing across the nation from LabCorp and Integrated Oncology, a member of the LabCorp Specialty Testing Group.