Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation (“Thermo Fisher”), a world leader in supplying life sciences solutions and services.
Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.
Illumina has launched a new benchtop next-generation sequencing (NGS) system designed to be more accessible for use in smaller labs.
Pillar Biosciences, Inc., has entered into a strategic partnership with AstraZeneca to expand laboratory access to molecular testing, using rapid, Next Generation Sequencing (NGS)-based liquid biopsy tumor profiling panels for detection of genetic cancer variants, with an initial focus on European markets and the UK.
Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.
To help accelerate research into new treatments for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, is partnering with the National Cancer Institute (NCI) – part of the National Institutes of Health – on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine umbrella trial. By testing patients’ bone marrow and blood for certain genetic biomarkers using Thermo Fisher’s next-generation sequencing (NGS) technology, clinical sites can more quickly match patients with an appropriate clinical trial that tests a treatment designed to target specific mutations present in the samples.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Thermo Fisher Scientific said Tuesday that it has signed a memorandum of understanding with Singapore’s National University Hospital (NUH) and Singapore RNA technology company Mirxes to develop and validate next-generation sequencing assays for early cancer detection in the country.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the release of a new version of its clinical decision support software, QIAGEN Clinical Insight Interpret (QCI Interpret), that brings significant performance and scalability enhancements tailored for high-throughput, next-generation sequencing (NGS) labs moving to larger test panels and higher test volumes. The latest version of QCI Interpret introduces improvements that accelerate critical lab performance criteria for turn-around-time, diagnostic yield and quality results.
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