Qiagen’s Companion Diagnostic Approved for NSCLC

The FDA has approved Qiagen’s therascreen KRAS kit as a companion diagnostic to Mirati Therapeutics’ Krazati (adagrasib) nonsmall-cell lung cancer (NSCLC) drug. 

The kit uses polymerase chain reaction (PCR) technology to detect KRAS G12C — the most common NSCLC mutation — to identify patients who could benefit from taking Krazati.

The KRAS kit is the result of a collaboration between Qiagen and Mirati inked in May 2021.

This is the fourth FDA approval for the kit. The other approved indications are for diagnosing NSCLC with EGFR mutation, colorectal cancer with KRAS mutation and urothelial cancer with FGFR mutation.