Sysmex Inostics Inc., a subsidiary of Sysmex Corporation, announced that its RAS-RAF-SEQ Laboratory Developed Test received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for use in clinical trials. The RAS-RAF-SEQ assay is a clinical-grade, CLIA-validated liquid biopsy designed to identify key mutations in the RAS-RAF and PI3K signaling pathways, which are implicated in various cancers, including colorectal, pancreatic, gallbladder, ovarian, and lung cancers.
Significance of RAS-RAF-SEQ Approval
The New York State CLEP approval for RAS-RAF-SEQ allows pharmaceutical companies and clinical trial investigators to utilize a non-invasive tool for assessing novel therapies targeting RAS-RAF and PI3K-associated cancers in samples from New York State. According to Shinichi Sato, President and CEO of Sysmex Inostics, this approval underscores the company's commitment to expanding access to its ultrasensitive assays, ensuring compliance with clinical regulations for patients battling cancer.
Understanding the RAS-RAF and PI3K Pathways
Genetic mutations along the RAS-RAF pathway (KRAS, NRAS, BRAF) are frequently observed in numerous cancer types and significantly influence cancer development, progression, and treatment resistance. Understanding a patient’s specific genomic alterations in these pathways is crucial for informing therapy selection, monitoring treatment response, and identifying emerging resistance. Mutations in the PI3K pathway (PIK3CA, AKT1) can also modulate signaling through the RAS-RAF pathway, providing additional insights for therapeutic decision-making.
The RAS-RAF-SEQ panel efficiently tracks key mutations in both the RAS-RAF and PI3K pathways, optimizing therapy, avoiding overtreatment, and maximizing the patient's quality of life during treatment.
Technology Behind RAS-RAF-SEQ
The Plasma-Safe-SeqS technology used in the RAS-RAF-SEQ assay is designed to preserve all input molecules for analysis, enabling ultrasensitive detection of low-level genomic mutations. Jonathan Craft, Associate Director, Translational Research at Sysmex Inostics, noted that the assay achieves ultra-sensitivity while maintaining robust specificity for the targeted mutations in the RAS-RAF or PI3K signaling pathways.
Clinical Utility and Impact
RAS-RAF-SEQ serves as a clinical-grade liquid biopsy assay for identifying gene mutations in KRAS, NRAS, BRAF, PIK3CA, and AKT1 in cancers affected by the RAS-RAF and PI3K signaling pathways. By applying ultrasensitive Plasma-Safe-SeqS technology, the assay identifies established and emerging predictive markers, resistance mutations, and frequently occurring genetic alterations associated with various cancers. This improves clinical trial efficiency by informing therapy selection, monitoring treatment response, and tracking disease and clonal dynamics, ultimately optimizing cancer therapy development.
