BALTIMORE , Sept. 17, 2024 /PRNewswire/ -- Sysmex Inostics Inc., a subsidiary of Japan's Sysmex Corporation and Baltimore -based biotechnology firm and CLIA-certified lab, announced that its RAS-RAF-SEQ Laboratory Developed Test has been granted the New York State Department of Health Clinical Laboratory Evaluation Program approval for clinical trial use.
RAS-RAF-SEQ is a clinical grade, CLIA-validated liquid biopsy assay for the identification of the five most relevant targets for cancers impacted by the RAS-RAF and PI3K signaling pathways such as colorectal, pancreatic, gallbladder, ovarian, and lung cancers. "NY State CLEP approval for RAS-RAF-SEQ will provide pharma and clinical trial investigators who want to test samples from the New York State with a non-invasive tool to uncover deeper insights in assessing novel therapies for various RAS-RAF and/or PI3K-associated cancers," said Shinichi Sato , President, and CEO of Sysmex Inostics. "This approval shows our commitment in expanding access of our ultrasensitive assays to all patients fighting cancer with liquid biopsy services that are compliant with clinical regulations.
" Genetic mutations along the RAS-RAF pathway ( KRAS , NRAS , BRAF ) are common across numerous cancer types, and often play a significant role in cancer development, progression, as well as treatment resistance. 1-3 Following initial diagnosis, understanding a patient's specific genomic alterations along the RAS-RAF pathway helps inform therapy selecti.