T2 Biosystems announced Wednesday that it has regained compliance with a listing requirement to remain on the Nasdaq.
Diasorin (FTSE MIB: DIA) announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s NxTAG® Respiratory Pathogen Panel (RPP) v2. This updated panel, an addition to Diasorin’s expanding molecular multiplexing portfolio, responds to customer needs by enhancing test usability.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an updated version of its clinical decision support platform, QIAGEN Clinical Insight Interpret for NGS molecular profiling of hereditary and somatic diseases, has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
Revvity's EUROIMMUN business, a leading provider of high-quality in-vitro diagnostic products, and ALPCO-GeneProof, a global leader in molecular diagnostics, jointly announced a strategic partnership to enhance the availability of GeneProof PCR kits throughout the European Union. This collaboration brings together EUROIMMUN's extensive distribution network and support infrastructure with ALPCO-GeneProof's innovative molecular diagnostic technologies.
A team led by researchers at the University of Michigan has developed and clinically validated an 18-gene urinary test for detecting high-grade prostate cancer.
Bosch has entered into a strategic partnership with the laboratory and medical technology company Randox Laboratories Ltd. The two companies are investing around 150 million euros in joint research, development and sales activities. This will result in new tests for the Vivalytic analysis platform from Bosch Healthcare Solutions. One objective is the development of an IVD (in vitro diagnostics) high multiplex sepsis test, which is to be implemented for the first time on the basis of the innovative BioMEMS technology.
Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients.
The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency.
Fujirebio Europe has acquired the nonexclusive distribution rights to Self-screen's PreCursor-M AnoGyn assay in Europe, the Middle East, Africa, and Asia, the companies said on Tuesday.
Ginkgo Bioworks (NYSE: DNA), a Boston, MA-based company which is building a platform for cell programming and biosecurity, announced the acquisition of Proof Diagnostics, a life sciences tools, diagnostics and computational discovery company.
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