Sysmex Inostics' RAS-RAF-SEQ Assay Receives New York State Department of Health CLEP Approval for Use in Clinical Trials

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 selection, monitor treatment response, and identify emerging resistance. Moreover, mutations in the PI3K pathway (PIK3CA, AKT1) are known to modulate signaling through the RAS-RAF pathway and may provide additional information to guide therapeutic decision-making.^1-3 The RAS-RAF-SEQ panel tracks key mutations in the RAS-RAF and PI3K pathways with maximum efficiency for optimizing therapy, avoiding over-treatment, and maximizing quality of life during treatment. 

Plasma-Safe-SeqS technology utilized in the RAS-RAF-SEQ assay is expertly designed to preserve all input molecules for analysis, leading to ultrasensitive detection of low-level genomic mutations. "The RAS-RAF-SEQ assay achieves ultra-sensitivity, while maintaining robust specificity for the targeted mutations in RAS-RAF or PI3K signaling pathway," said Jonathan Craft, Associate Director, Translational Research, Sysmex Inostics.

About RAS-RAF-SEQ
RAS-RAF-SEQ is a clinical grade, CLIA-validated liquid biopsy assay for the identification of gene mutations in KRAS, NRAS, BRAF, as well as PIK3CA and AKT1 for cancers impacted by the RAS-RAF and PI3K signaling pathways. Applying ultrasensitive Plasma-Safe-SeqS technology to identify mutant molecules at low levels, RAS-RAF-SEQ identifies established and emerging predictive markers, resistance mutations, frequently occurring genetic alterations associated with various cancers, and mutations that may evolve during therapy. RAS-RAF-SEQ improves clinical trial efficiency by informing therapy selection, monitoring treatment response along with disease and clonal dynamics, as we strive to optimize cancer therapy development.

About Sysmex Inostics
Sysmex Inostics, Inc., a subsidiary of Japan's Sysmex Corporation, is a Baltimorebased biotechnology firm and CLIA-certified lab offering biomarker testing to accelerate the development of personalized medicine. Pioneering liquid biopsy technology with OncoBEAM™ in 2008, Sysmex Inostics now provides next generation sequencing Plasma-Safe-SeqS technology panels. The Plasma-Safe-SeqS panels empower more accurate detection of low-frequency biomarkers with ultra-sensitive 0.03% to 0.05% allele frequency from a simple blood draw to expedite studies and uncover deeper insights into therapy response. The company offers CLIA validated NGS testing services for HPV16/18 quantification, HNSCC, AML, breast cancer, and solid tumors impacted by RAS-RAF and PI3K signaling pathways. 

For more information, refer to www.sysmex-inostics.com

References:

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2. Gimple RC, Wang X. Front Oncol. 2019;9:965. Published 2019 Sep 24. doi:10.3389/fonc.2019.00965
3. Cuesta C, Arévalo-Alameda C, Castellano E. Genes (Basel). 2021;12(7):1094. Published 2021 Jul 19. doi:10.3390/genes12071094

SOURCE Sysmex Inostics