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FDA approves Qiagen CDx for NSCLC

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Qiagen said a press release that the tissue-based KRAS companion diagnostic assay was developed specifically to identify patients with NSCLC who have a KRAS G12C mutation. Krazati 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. Qiagen and Mirati Therapeutics announced their partnership to develop the companion diagnostic in May 2021.

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