The Ministry of Food and Drug Safety has approved Qiagen Korea’s therascreen KRAS RGQ PCR Kit, the first companion diagnostic genetic test reagent to detect KRAS G12C gene mutations in patients with non-small cell lung cancer (NSCLC).

The ministry based its approval on a clinical study conducted with Amgen's Lumakras (Ingredient: sotorasib) and the therascreen kit.

The study used Qiagen's kit to select the patient group, confirming that Lumakras reported a higher objective response rate, progression-free survival, and overall survival in NSCLC patients with KRAS G12C gene mutation compared to patients without KRAS G12C gene mutation.

According to the company, KRAS oncogene mutations occur in about 25 percent of NSCLC patients. KRAS G12C gene mutation occurs in about 13 percent of NSCLC patients among various subtypes of KRAS gene mutation. Mutations in the KRAS gene can promote tumor growth due to uncontrolled cell growth, and patients with KRAS G12C mutations have a poor prognosis due to resistance to existing treatments and a low survival rate.

Qiagen's kit can detect KRAS G12C mutation in tumor tissue samples from NSCLC patients through real-time PCR. The company stressed that it provides stable and reliable results by verifying and monitoring the entire process, from sample preparation to analysis results. It conducts a qualitative test using real-time gene amplification technology.

Also, the kit is the only in-vitro diagnostic reagent in Korea that can detect KRAS G12C gene mutation in NSCLC patients and was the first kit to receive approval as a companion diagnostic test for patients with NSCLC by the U.S. Food and Drug Administration in May last year.

The kit is used with Qiagen's automated solution, the Rotor-Gene Q MDx device.

"The product approval for the therascreen KRAS RGQ PCR Kit opens the way for NSCLC patients with KRAS G12C gene mutation, who have not had a treatment option, to select a new treatment option through genetic testing," said William Lin, Qiagen's director of commercial operation for Korea and Southeast Asia. "Qiagen will make efforts to solve the unmet need in NSCLC treatment by selecting the patients who are eligible for the prescription of Lumakras by rapidly commercializing the therascreen KRAS RGQ PCR Kit as a companion diagnostic test."