QIAGEN has secured approval for its therascreen KRAS RGQ PCR kit (therascreen KRAS kit) from the US Food and Drug Administration (FDA) as a companion diagnostic (CDx) test to KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC).

KRAZATI, which is owned by Mirati Therapeutics, was given accelerated approval earlier this week by the FDA for the treatment of adults having KRAS G12C-mutated locally advanced or metastatic NSCLC.

The therascreen KRAS RGQ PCR kit can be used as a CDx to help in identifying patients who are eligible for treatment with KRAZATI.

Mirati Therapeutics and QIAGEN announced their cooperation last year.

Mirati Therapeutics translational medicine and companion diagnostics vice president Kenna Anderes said: “It is critical to expand access to genomic testing for both health care providers and people living with cancer equipping them with meaningful information to inform treatment plans.

“The partnership with QIAGEN has led to meaningful advancements in the development of KRAS-specific biomarker testing.”

QIAGEN developed the tissue based KRAS companion diagnostic assay precisely for identifying patients with NSCLC harbouring KRAS G12C mutation.

QIAGEN vice president and oncology and precision diagnostics head Jonathan Arnold said: “therascreen KRAS is a fast and cost-effective test ensuring physicians receive patient reports in the most efficient and straight forward way to make treatment decisions.

“This last approval is confirming and strengthening QIAGEN leadership in RAS companion diagnostics.”

For QIAGEN, this is the fourth approval of the therascreen KRAS RGQ PCR kit. It adds to the existing three therapies indicated previously in the label for use in NSCLC and colorectal cancer (CRC).

Also, the new approval of therascreen KRAS takes QIAGEN’s FDA approvals of PCR based companion diagnostic indications to 11.

Apart from the QIAGEN product, the FDA approved Agilent Technologies’ Agilent Resolution ctDx FIRST as a liquid biopsy CDx to identify patients who can benefit from treatment with KRAZATI.