TEST:

therascreen® KRAS RGQ PCR Kit

The similarity in KRAS mutation rates across races raises the possibility that the differences in KRAS mutation rates reported from various countries may either not be statistically significant or may be due to environmental and/or laboratory factors rather than underlying racial genetic differences. In contrast, we verified that BRAF mutation rates differ significantly between races, suggesting racial genetic differences may be responsible for the discrepant BRAF mutation rates reported from different countries.

"Recently, sotorasib was developed as a molecular targeted drug for KRAS mutations...By the PNA-LNA PCR clamp method, G12C mutation of surgical specimens was detected successfully. The PNA-LNA PCR clamp method is expected to be applied to the detection of druggable G12C mutations."

P3; Trial primary completion date: Jun 2023 --> Mar 2025

P3, N=160, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting

P3, N=153, Recruiting, Amgen | Trial completion date: Mar 2024 --> Feb 2025

"QIAGEN...has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen® KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutic’s drug KRAZATI® (adagrasib) for non-small cell lung cancer (NSCLC)...The tissue based KRAS companion diagnostic assay, which QIAGEN developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI....With the new approval of therascreen KRAS for NSCLC, QIAGEN has eleven PCR based companion diagnostic indications that are FDA approved – the broadest portfolio of IVD approved PCR based companion diagnostics on the market."

P=N/A; N=309; Active, not recruiting; Sponsor:QIAGEN Gaithersburg, Inc

P=N/A; N=495; Active, not recruiting; Sponsor:QIAGEN Gaithersburg, Inc

P3; N=200; Recruiting; Sponsor:QIAGEN Gaithersburg, Inc

"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 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....Qiagen's kit can detect KRAS G12C mutation in tumor tissue samples from NSCLC patients through real-time PCR."

"RAS mutation frequencies in the Czech CRC patients were similar to previous reports, although rare mutations were also detected. DAS with short amplicons is a good strategy for routine assessment of somatic mutations in low-quality FFPE-derived DNA."

"Three differences of prevalence are observed in our study for mexican population with lung AC: EGFR 32.7%, 13.9% KRAS and ALK 6.7%. According to recent NGS studies in Mexico, EGFR has a prevalence of 36.7% and 20% for KRAS. In Mexico and Latin America (LA) the mutational frequency is inverse compared to Caucasian population, with KRAS (20-25%) being more frequent than EGFR (10-15%) and ALK (4.5-5%)."

Comprehensive genotyping for all therapeutic targets including KRAS p.G12C is critical for management of NSCLC. Liquid biopsy using Guardant360 CDx has clinical validity for identification of patients with KRASp.G12C-mutant NSCLC and, augmented by tissue testing methodologies as outlined on the approved product label, will identify patients for treatment with sotorasib.

The ORR was 37.1% in pts positive by tissue and 36.4% in those positive by cfDNA (Table). In 189 pts eligible for concordance study, the overall concordance was 81.5%, with positive and negative % agreements of 70.1% and 100.0%, respectively.