Labcorp announced the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with LUMAKRAS (sotorasib), a new treatment option developed by Amgen.
The therapy and the use of the test, which was developed by Qiagen, as a companion diagnostic received approval from the U.S. Food and Drug Administration (FDA) in late May 2021. The therascreen KRAS PCR Mutation Analysis allows labs, such as Labcorp, to determine if patients carry a specific mutation in the KRAS gene.
According to Labcorp, this is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with NSCLC whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. KRAS mutations have been found to enable cells in certain cancers to grow and spread more easily.
