QIAGEN’s therascreen tissue CDx KRAS Kit claims to detect KRAS G12C, a genetic mutation estimated to be present in up to 13% of cases of NSCLC and usually resistant to therapies. It is a first-in-class drug inhibitor of the G12C-mutated form of the KRAS protein, developed and marketed by Amgen. Lumakrastm (sotorasib) is the first and only FDA-approved targeted treatment for patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The test will be available under QIAGEN’s Day One Lab Readiness program. QIAGEN has also made the immediate launch of this expanded scope of companion diagnostic (CDx) claims for therascreen KRAS Kit following the approval. The latest regulatory go-ahead enables it to be used as a companion diagnostic in guiding treatment with Amgen’s AMGN newly-approved lung cancer targeted drug LUMAKRASTM (sotorasib). QGEN recently received FDA approval of its therascreen KRAS RGQ PCR (Polymerase Chain Reaction) Kit for an expanded scope of use.

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