COMPANY:

Sysmex Corp

Sysmex Inostics Inc...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."

"Sysmex Inostics Inc...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."

"Sysmex Corporation...announces...that it has expanded its strategic Alliance Agreement with QIAGEN N.V...to deepen their collaboration in genetic testing, including research and development, production, clinical development, and sales-marketing."

"OGT...announces the launch of the RNA-based SureSeq™ Myeloid Fusion Panel, a new next-generation sequencing (NGS) tool for identifying key fusion genes implicated in acute myeloid leukaemia (AML)."

"OGT...announces the opening of state-of-the-art facilities within the Oxford Technology Park. The move represents a multi-million-pound investment, fuelled by consistent company growth and growing customer demand. Equipped with cutting-edge technology, the facilities will drive development of OGT’s trusted SureSeq™ next generation sequencing (NGS) product portfolio, as well as deliver expert-led training and enhanced opportunities for collaboration."

"OGT, A Sysmex Group Company, will showcase its soon to be launched SureSeq™ Myeloid MRD Panel at booth #1423 at the Association for Molecular Pathology (AMP) 2023 Annual Meeting & Expo, 14-18th November in Salt Lake City. The Next-generation sequencing (NGS) panel represents a substantial improvement on conventional flow cytometry and qPCR methods of detecting measurable residual disease (MRD) in acute myeloid leukaemia (AML) samples—providing outstanding sensitivity and coverage uniformity in one rapid and cost-effective assay."

"OGT, A Sysmex Group Company...and Intelliseq...are delighted to announce the release of GeneSpect™ Somatic Reporter for use with OGT’s SureSeq™ portfolio of next generation sequencing (NGS) panels. This advanced analytical reporting solution pairs state-of-the-art variant interpretation and reporting with OGT’s class-leading NGS panels and bioinformatics solutions. Users of SureSeq Myeloid panels can now benefit from insightful tertiary reporting for all myeloid malignancy content and variants with the GeneSpect Somatic Reporter."

"OGT, a Sysmex Group Company...is delighted to announce its new partnership with Intelliseq...This collaboration combines OGT's expansive SureSeq™ NGS portfolio with Intelliseq's state-of-the-art iFlow™ engine, resulting in a thorough and comprehensive NGS workflow—from sample to report. This advancement will greatly enhance lab productivity by automating the interpretation of NGS data and deliver actionable insights into cancer."

"Sysmex Corporation...is now covered by health insurance in Japan as a companion diagnostic for futibatinib,1 a treatment for unresectable biliary tract cancer2 harboring FGFR2 gene fusions3 that has progressed after chemotherapy. Futibatinib was developed by Taiho Pharmaceutical Co., Ltd....Riken Genesis Co., Ltd (HQ: Shinagawa-ku, Tokyo, Japan; President: Kenji Iwakabe), a subsidiary of Sysmex, will begin assay services in Japan corresponding to this insurance coverage from September 2023."

"OGT, a Sysmex Group Company...announces a new commercial partnership with Applied Spectral Imaging (ASI)...The agreement will grant OGT rights to market ASI’s proprietary cytogenetic imaging and analysis solutions in Great Britain, establishing a strategic partnership that combines the strengths of OGT’s CytoCell® FISH portfolio with ASI’s imaging and analysis capabilities to deliver operational efficiency in end user’s laboratories."

"Sysmex Inostics Inc...is exhibiting at the American Association for Cancer Research® (AACR) Annual Meeting 2023 in Orlando, FL from April 16, 2023, through April 19, 2023. The company is exhibiting at 'Booth 1325' to meet with the over 20,000 global cancer research professionals in attendance."

"Sysmex Inostics Inc...and Genomic Testing Cooperative (GTC), based in Irvine, California, formed a strategic partnership for Sysmex Inostics to commercialize GTC’s tissue and liquid biopsy solid tumors and hematology assay services to biopharma customers. This includes GTC’s Solid Tumor Profile Plus, Liquid Trace Solid Tumor Profile, Liquid Trace Hematology Profile, and Hematology Profile Plus assay services."

"Sysmex Europe and Cerca Biotech said...that they have inked a deal for Sysmex to distribute Cerca's molecular breast cancer assay in 13 European markets...German diagnostic firm Cerca's RT-qPCR MammaTyper assay is used to identify breast cancer subtypes through quantitative measurement of mRNA expression status for four genes in breast cancer tissue."

"OGT, A Sysmex Group Company, announces that IVDR-certification has been granted for eight CytoCell® fluorescence in situ hybridisation (FISH) probes, important for patient management in haematological cancers and prenatal conditions. This award places OGT as the first manufacturer of FISH probes to obtain the new IVDR certification on its products—demonstrating continued safety, reliability and effectiveness under this substantially more stringent regulation."

"Sysmex Corporation...applied on September 2, 2022 for a partial change of the manufacturing and marketing approval for the OncoGuide™ NCC Oncopanel System, a gene mutation analysis set (the 'System') to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions."

"Sysmex Corporation...has announced today that it has formed a global strategic alliance with QIAGEN N.V...for the development of cancer companion diagnostics...Sysmex is working to strengthen its global relationship with pharmaceutical companies in order to develop companion diagnostics and timely launch them by capitalizing on Plasma-Safe-SeqS technology, a liquid biopsy developed by Sysmex using a next-generation sequencer (NGS), while leveraging QIAGEN’s experience in developing companion diagnostics."

"QIAGEN...and Sysmex Inostics combined forces in July 2021 to accelerate global companion diagnostic access. QIAGEN provides unparalleled global custom cancer companion diagnostics (CDx) development and commercialization capabilities utilizing Sysmex Inostics ultra-sensitive NGS liquid biopsy technology...will present the poster "Plasma RAS dynamics and anti-EGFR rechallenge efficacy in patients with RAS/BRAF wild-type metastatic colorectal cancer: REMARRY and PURSUIT trials." Circulating tumor DNA (ctDNA) was analyzed and monitored using the Sysmex Inostics OncoBEAM™ RAS CRC Kit."

"Sysmex Inostics...has expanded its offering of CLIA-validated tests to include AML-SEQ™, a focused panel to detect mutations of the three most prevalent genes found in Acute Myeloid Leukemia (AML) – IDH1/2 & NPM1...AML-MRD-SEQ is a more extensive panel for the detection of measurable residual disease (MRD) in 68 regions across 20 genes including the clinically established IDH1/2 and NPM1."

"Sysmex Inostics...will introduce HNSCC-SEQ, a highly sensitive Plasma-Safe-SeqS and Next Generation Sequencing (NGS) assay service for head and neck squamous cell carcinomas (HNSCC), at the annual 2022 Molecular Medicine Tri-Conference being held Monday, February 21st through Wednesday, February 23rd in San Diego, California. The assay has a turn-around-time of 7-10 days and is available to researchers and clinicians."

"Sysmex Inostics...announces the use of their HPV-SEQ test in the prospective University of Chicago clinical trial, 'Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer...HPV-SEQ, Sysmex Inostics ultra-sensitive quantitative, CLIA-validated, blood test for the detection of cell-free HPV 16/18 DNA (cfHPV-DNA), will be used in the trial to monitor personalized treatment and de-escalation of HPV positive oropharyngeal cancer (OPC) patients."