Qiagen announces FDA approval of therascreen KRAS RGQ PCR kit as companion test

Qiagen has announced the FDA approval of its therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutic’s drug Krazati for non-small cell lung cancer, or NSCLC. Qiagen and Mirati Therapeutics (MRTX), a targeted oncology company, announced their cooperation in May 2021. The tissue based KRAS companion diagnostic assay, which Qiagen developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI. The drug is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA approved test, who have received at least one prior systemic therapy.