NEW YORK – Sysmex Inostics said Tuesday that it has secured New York State Department of Health approval for clinical trial use of the firm's liquid biopsy assay for biomarkers that are relevant for the treatment of multiple cancer types.
Baltimore-based Sysmex Inostics, a subsidiary of Japan-based Sysmex, said that New York state's Clinical Laboratory Evaluation Program granted approval for Sysmex's CLIA-validated RAS-RAF-SEQ assay, which is used for the identification of mutations in KRAS, NRAS, BRAF, PIK3CA, and AKT1 genes in cancers that are impacted by the RAS-RAF and PI3K signaling pathways. Those mutations are relevant for the selection and monitoring of therapies for colorectal, pancreatic, gallbladder, ovarian, and lung cancers, among others. The mutations are often related to cancer development, progression, and treatment resistance.
The assay uses the firm's ultrasensitive Plasma-Safe-SeqS technology for the identification of predictive markers, resistance mutations, genetic alterations, and mutations that may evolve during therapy. Jonathan Craft, associate director for translational research at Sysmex Inostics, said in a statement that the RAS-RAF-SEQ assay achieves ultra-sensitivity and robust specificity for the targeted mutations.