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Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx

NEW YORK – Agilent Technologies and Qiagen said on Monday and Tuesday respectively that they have gained US Food and Drug Administration approval of companion diagnostic assays for use with a new treatment for patients with advanced non-small cell lung cancer.

The Agilent Resolution ctDx FIRST next-generation sequencing-based liquid biopsy assay and Qiagen's tissue-based Therascreen KRAS RGQ PCR kit will be used to determine which patients are likely to benefit from Mirati Therapeutics' drug Krazati (adagrasib), a treatment for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. Mirati said on Monday the FDA had granted accelerated approval for the drug based on the rate and duration of patient response to treatments, and continued approval depends on the results of confirmatory trials.

Santa Clara, California-based Agilent said that its ctDx FIRST assay detects genomic alterations in circulating tumor DNA from plasma and provides broad genomic profiling on 109 genes with single nucleotide variants, insertions and deletions, copy number amplifications, and fusions.

Hilden, Germany-based Qiagen said in May 2021 that it was partnering with Mirati to develop a real-time qualitative PCR companion diagnostic for adagrasib. Qiagen said Tuesday its test provides fast, cost-effective testing to aid treatment decisions.

Kenna Anderes, Mirati's VP of translational medicine and companion diagnostics, added that accurate and fast genomic profiling is essential to unlocking medicines for patients.