COMPANY:

Sysmex Corp

"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."

"Sysmex Inostics has developed a new CLIA-validated liquid biopsy test for the detection of Minimal Residual Disease (MRD) in Acute Myeloid Leukemia (AML). A global leader and pioneer in blood-based, ultra-sensitive molecular testing for oncology, the company’s new test uses a targeted Next Generation Sequencing (NGS) panel...This new test, AML-MRD-SEQ, adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics’ CLIA lab services in Baltimore, Maryland."

"QIAGEN...announced a global strategic alliance with Japan’s Sysmex Corporation (Tokyo Stock Exchange, First Section [Ticker Code: 6869]) for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS)...The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics."

"Sysmex Corporation...announced that the Company obtains the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR)1 certification, a first for one of our products, for the gene amplification detection reagent LYNOAMP CK19 E, which uses the OSNATM method2 developed by Sysmex as the measurement principle, from TÜV SÜD Product Service GmbH on June 4, 2021."

P2, N=76; OPTIMA-II (NCT03107182); "Sysmex Inostics, Inc...is presenting the poster entitled, 'Ultra-sensitive detection and quantification of human papillomavirus (HPV) DNA in the plasma of patients with oropharyngeal squamous cell carcinoma (OPSCC) enrolled in the OPTIMA 2 treatment de-escalation trial' at the 2021 ASCO Annual Meeting, June 4-8, 2021. The featured data show that SafeSEQ cfHPV-DNA Test (HPV-SEQ) exhibits robust quantitative detection of cell-free HPV DNA (cfHPV-DNA) across a broad dynamic range, enabling high-resolution monitoring for patients with HPV+ OPSCC, a type of head and neck cancer....'HPV-SEQ exhibits robust quantitative detection of HPV, even when only a few copies are present, thus potentially enabling precise molecular monitoring of patients' therapy response,' said Dr. Nishant Agrawal..."

"Sysmex Europe GmbH, together with Sysmex Inostics GmbH, has announced that they will launch the Plasma-SeqSensei™ liquid biopsy research use only (RUO) kits for colorectal cancer (CRC), non-small cell lung cancer (NSCLC), melanoma and thyroid cancer…Sysmex is launching four reagent kits with a highly convenient software to enable the use of this highly sensitive technology for RUO purposes in four different types of cancers, namely CRC, NSCLC, melanoma (skin cancer) and thyroid cancer. The liquid biopsy market is expected to grow rapidly by >40% per year to 1B USD over the next three to five years."

"Sysmex Corporation...announced today that on February 1, 2021, it received approval for a partial change to the manufacturing and marketing approval for the OncoGuide NCC Oncopanel System,1 a gene mutation analysis set for use in cancer genome profiling (the 'System'), which was made as a result of an enhancement of the System's functions, including an expanded scope of detectable gene mutations. With this change, it has become possible to detect mutations and copy number alterations of 124 genes, fusions 2 of 13 genes, and microsatellite instability3 (MSI), up from the mutations and copy number alterations of 114 genes before."

"Roche...today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents...The GBP agreement will allow Roche and Sysmex to deliver tailored haematology solutions to new and existing customers, while having the benefits of working with a single provider. Streamlining testing efficiency and effectiveness are an important part of a laboratory’s remit."

"Sysmex Inostics, Inc...is presenting the poster 'Ultrasensitive Measurable Residual Disease (MRD) Detection in Acute Myeloid Leukemia (AML) Using a Targeted Next Generation Sequencing (NGS) Panel' at the 62nd Annual American Society of Hematology (ASH) Virtual Meeting on Saturday, December 5th...In addition to demonstrating robust analytical performance, 100% overall agreement was observed between SafeSEQ and OncoBEAM for the detection of IDH1 mutations in clinical samples from AML patients. Furthermore, in almost all (94%) patients tested, at least one additional mutation outside of IDH1 was detected by the SafeSEQ AML MRD assay, which is consistent with previous observations that IDH mutations can co-occur with drivers in other genes such as NPM1 and may provide additive value for MRD detection."

"Sysmex Inostics, Inc…today announces the publication of a clinical study investigating the utility of cfDNA-based markers using the highly sensitive OncoBEAM RAS assay, an enhanced digital PCR test optimized for high sensitivity blood-based mutation detection, as a prognostic tool in patients with metastatic pancreatic ductal adenocarcinoma (PDAC)."

"Sysmex Corporation…announces the July 2020 launch of its OncoGuide^TM NET1 expert panel support system (the ‘System’), which enhances the administrative efficiency of expert panels in cancer genome profiling. The OncoGuideTM NET allows for the sharing of information needed for discussions by expert panels, which consist of experts in various disciplines from multiple medical institutions, and arrangement of session schedules."