Sysmex Inostics GmbH

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 References: Santarpia L, Lippman SM, El-Naggar AK. Expert Opin Ther Targets. 2012;16(1):103-119. doi:10.1517/14728222.2011.645805 Gimple RC, Wang X. Front Oncol. 2019;9:965. Published 2019 Sep 24. doi:10.3389/fonc.2019.00965 Cuesta C, Arévalo-Alameda C, Castellano E. Genes (Basel). 2021;12(7):1094. Published 2021 Jul 19. doi:10.3390/genes12071094 SOURCE Sysmex Inostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BALTIMORE, Aug. 27, 2024 /PRNewswire/ -- Sysmex Inostics Inc., a subsidiary of Japan's Sysmex Corporation and Baltimore-based biotechnology firm and CLIA-certified lab, in collaboration with the University of Chicago Medicine announces the publication of results from the OPTIMAII trial in JAMA Oncology. Circulating tumor HPV-DNA (ctHPV-DNA) clearance, monitored using HPV-SEQ assay, predicts improved survival in patients with HPV-associated oropharyngeal cancer following nivolumab-based neoadjuvant therapy. "At Sysmex Inostics, we recognize the critical role of ctHPV-DNA monitoring in accelerating drug development and ultimately optimizing patient care and treatment management for HPV-driven cancers," said Shinichi Sato, President, and CEO of Sysmex Inostics. "We are excited about the latest findings using HPV-SEQ published in JAMA Oncology. These collaborative efforts with academia and pharma attest to our commitment in expediting the use of this novel biomarker in clinical settings," said Sato. This is the first clinical trial to assess immunotherapy (nivolumab) in the neoadjuvant chemotherapy setting with response-adapted deintensification therapy. Non-invasive biomarkers such as PDL-1 and ctHPV-DNA were assessed pre/post-treatment to understand their clinical utility in treatment monitoring and surveillance, especially as a future tool to guide treatment strategy for treatment de-intensification. Key results from the study include: All (31, 100%) patients with paired samples at baseline and after 2-3 cycles of neoadjuvant therapy, had detectable and quantifiable ctHPV-DNA at baseline. All (31, 100%) patients showed quantitative reduction of ctHPV-DNA with neoadjuvant therapy along with clinical assessment of radiographic response. Majority of patients (26/31) had clearance of ctHPV-DNA during neoadjuvant therapy, while 5 patients had detectable and persistent ctHPV-DNA after 6-9 weeks of neoadjuvant therapy. 2-year PFS was significantly improved for patients with neoadjuvant clearance of ctHPV-DNA as compared with those with persistent ctHPV-DNA (p=0.0018). Exciting about the findings from this paper, lead author Ari Rosenberg, MD, an oncologist at UChicago Medicine, said, "We are seeing mounting evidence that ctHPV-DNA is very useful in grading response to treatment and warrants investigation in guiding treatment decisions such as selecting patients for treatment de-intensification." This study suggests that ctHPV-DNA clearance may be an improved surrogate biomarker to grade treatment response to neoadjuvant therapy and serve as a non-invasive tool to select patients for de-intensification. Importantly, ctHPV-DNA is a sensitive dynamic biomarker which along with deep response may offer advantages and complementary information compared with baseline, static biomarkers. About HPV-SEQ HPV-SEQ is an ultra-sensitive, CLIA-validated NGS-based assay for detection and quantification of cell-free HPV-DNA. It can detect as low as 2 copies of HPV 16 and HPV 18 DNA, offering high analytical and clinical sensitivity. It is currently being utilized in several clinical trials of HPV-associated cancers for monitoring of treatment response. About Sysmex Inostics Sysmex Inostics, Inc., a subsidiary of Japan's Sysmex Corporation, is a Baltimore-based 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. SOURCE Sysmex Inostics

DUBLIN, March 28, 2024 /PRNewswire/ -- The "Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering. The Clinical Laboratory rose to the COVID challenge, but the end of the pandemic has created a new approach to diagnostics. Point of Care and Self Testing are threatening long term demand for clinical lab services but Molecular Diagnostics is driving runaway growth. Understand the opportunities and the threats in this comprehensive report. The fundamentals are still here. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations. Trends like: The genetic blizzard Emerging economies and global prosperity Pharmacogenomics Healthcare expansion in China Climate change Globalization Automation Exciting technical developments especially in the area of molecular diagnostics and pharmacogenomics hold the promise of a dynamic, growing and evolving world market that is moving out of the national and regional orientation and onto a global stage. The report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions. Based on extensive primary and secondary research the testing volume data is broken down into price and volumes allowing researchers and investors to quickly create informed and reasonable forecasts of demand. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth. The report includes detailed breakouts for 15 Countries and 4 Regions. The report includes five year market forecasts. Key Topics Covered: 1 Market Guides 1.1 Clinical Laboratory Services - Strategic Situation Analysis and Covid-19 Impact 1.2 Guide for Executives, Marketing, Sales and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 The Growing Demand for Clinical Testing 2.2 Defining the Opportunity 2.2.1 Volumes 2.2.2 Prices 2.2.3 Revenue Market Size 2.3 Methods and Sources 2.3.1 Authors 2.3.2 Sources 2.4 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic 2.4.1 Global Healthcare Spending 2.4.2 Spending on Diagnostics 2.4.3 Important Role of Insurance for Diagnostics 3 Overview of a Dynamic Market 3.1 Players in a Dynamic Market 3.1.1 Academic Research Lab 3.1.2 Diagnostic Test Developer 3.1.3 Genomic Instrumentation Supplier 3.1.4 Pharmaceutical/Reagent Supplier 3.1.5 Independent Testing Lab 3.1.6 Public National/regional lab 3.1.7 Hospital lab 3.1.8 Physician Lab 3.1.9 Audit Body 3.1.10 Certification Body 3.2 Segmentation - Different Approaches 3.2.1 Traditional Market Segmentation 3.2.2 Laboratory Focus and Segmentation 3.3 Structure of Clinical Testing Industry 3.3.1 The Hospital Lab - Share of the Pie 3.3.2 Key Role for Economies of Scale 3.3.3 Physician Office Lab's are Still Here 3.3.4 Physician's and POCT - Reviving Patient Service in China 3.4 National and Regional Diversity 4 Trends Driving a Changing Market 4.1 Growth Is Pushed from Many Sides 4.1.1 Understanding the Impact of Aging Population 4.1.2 COVID Related Testing Growth 4.1.3 Point of Care Testing can increase demand 4.1.4 Alternative Medicine Creates Testing Opportunity 4.1.5 Esoteric Testing Moving Mainstream 4.1.6 Genetic Based Testing Creates New Department and New Discipline 4.2 Factors at Work to Shrink the Market 4.2.1 Lower Unit Costs 4.2.2 Economic or population contraction 4.2.3 Testing usage analysis curtailing growth 4.2.4 Wellness has a downside 4.2.5 Test Displacement Impacts Important 4.2.6 Point of Care Testing 4.3 Automation 4.3.1 Stranded LIMS Investment 4.3.2 Software as a Service 4.3.3 Physician Office and Access Systems 4.4 Environment and Evolution 4.5 Diagnostic Technology Development 4.5.1 Next Generation Sequencing Fuels a Revolution 4.5.2 Impact of NGS on pricing 4.5.3 POCT/Self Testing Disruptive Force 4.5.4 Pharmacogenomics Blurs Diagnosis and Treatment 4.5.5 CGES Testing, A Brave New World 4.5.6 Molecular Diagnostics Technologies at The Forefront of Growth 4.5.7 Biochips/Giant magneto resistance based assay 5 Laboratory, Molecular Diagnostics and Genomic Testing Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 Seegene to Enter Syndromic MDx Space 5.3 EKF Diagnostics Acquires Advanced Diagnostic Laboratory 5.4 Molecular Health, EDGC Ink Liquid Biopsy Partnership 5.5 ProPhase Labs Acquires Nebula Genomics for $14.6M 5.6 Karius Cell-Free DNA Method to Detect Infection Validated 5.7 South Korean Firm EDGC to Expand Into Liquid Biopsy Space With Cf DNA Platform 5.8 TruDiagnostic Receives CLIA Certification for Kentucky Laboratory 5.9 Enzo Biochem Q2 Revenues Up 62 Percent 5.10 Thermo Fisher Gets CE Mark for High-Throughput COVID-19 Assay 5.11 FDA Issues Alert - False Negatives due to SARS-CoV-2 Mutations 5.12 Will Labs Use Expanded Molecular Testing Capacities Post-COVID-19? 5.13 Chinese Infectious Dx Firm Vision Medicals Completes Series B Financing 5.14 Cooperative Aims to Expand Clinical, Commercial NGS Access 5.15 Emerging COVID-19 Sequencing Assays - An Alternative to Existing Diagnostics? 5.16 CDC Ranks Two More Microbes as 'Urgent Threat' 5.17 ACLA Requests $5 billion to keep private labs going 5.18 Applied Biology to Launch New Laboratory for Hair and Skin Disorders 5.19 Quest Diagnostics Acquires Outreach Operations 5.20 Quest Diagnostics Buys Assets of Boston Clinical Laboratory Services 5.21 CLA Urges FDA to Halt Crackdown on PGx Testing 5.22 Quest Diagnostics Subsidiary Buys True Health Dx Assets 5.23 BioReference Laboratories selected by IPA Association 6 Profiles of Key Companies Acibadem Labmed Laboratory ACM Medical Laboratory Adicon Clinical Laboratories American Bio-Clinical Laboratories, Int'l American Pathology Partners ARUP Laboratories Ascend Clinical Assurance Scientific Laboratories Aurora Diagnostics Bio-Reference Laboratories Bioscientia Institut fur Medizinische Diagnostik GmbH BP Healthcare Group Clinical Reference Laboratory Clongen Laboratories CompuNet Clinical Laboratories Diagnosticos da America DIAN Diagnostics Co., Ltd. Enzo Biochem Eone Laboratories Eurofins Scientific Exagen Diagnostics Genzyme Corporation Gribbles Pathology Guangzhou Kingmed Diagnostics Group Co., Ltd. Integrated Regional Laboratories KDL Group Laboratory Corporation of America Lifelabs Mayo Clinic Laboratories Mid America Clinical Laboratories MNG Labs Myriad Genetics/Myriad RBM NeoGenomics OncoDNA Pathology, Inc. ProPhase Labs Psychemedics Corporation Quest Diagnostics RDL Reference Laboratory Sonic Healthcare Spectra Laboratories Sysmex Inostics Unilabs For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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