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Isohelix Files US FDA Pre-Submission for GeneFix Saliva DNA Collectors
Isohelix (UK) announces that it has commenced engagement with the U.S. Food and Drug Administration to progress the full regulatory approval of the GeneFix® Saliva DNA Collectors into the USA.
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Mainz Biomed Announce IRB Approval and Initiation of US Pivotal FDA Clinical Study
Mainz Biomed has received approval from an independent Institutional Review Board for the protocol ReconAAsense, the Company’s US pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer.
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New dPCR Liquid Biopsy Assays for QuantStudio Absolute Q dPCR System and Custom Design Tool Simplify Cancer Research
Thermo Fisher Scientific has introduced over 50 new Absolute Q Liquid Biopsy Assays to run on the Applied Biosystems QuantStudio Absolute Q dPCR System.
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Thermo Fisher Scientific Updates Applied Biosystems 3500 and 3500xL Dx Genetic Analyzers To Comply With IVDR Regulations
Thermo Fisher Scientific has updated its Applied Biosystems 3500 and 3500xL DX genetic analyzers to comply with IVDR regulations.
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Personalis and UCSF To Study Clinical Utility of ctDNA for Treatment Response in Colorectal Cancer
Personalis has announced a collaboration with UC San Francisco that will deploy a personalized liquid biopsy-based research use only assay for a study of patients with colorectal cancer.
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Mainz Biomed Announces US Extension of ColoFuture Study To Evaluate Integration of Novel mRNA Biomarkers Into ColoAlert
Mainz Biomed has announced the initiation of eAArly DETECT, its US extension of ColoFuture, which is the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert.
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Arima Genomics Presents Data on Cancer Structural Variants at the Association of Molecular Pathology Annual Meeting
Arima Genomics, Inc. has announced that new data on the detection of actionable structural variants from cancer samples embedded in formalin-fixed, paraffin-embedded tissues will be presented at the Association of Molecular Pathology Annual Meeting.
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Fortis Life Sciences Expands its International Presence
Fortis Life Sciences has expanded its international presence by opening an office in Seoul, South Korea.
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EKF Introduces Hand-Held Hemoglobin Analyzer With Secure POC Connectivity
EKF Diagnostics announces an enhanced DiaSpect Tm, that now connects securely to the company’s own point-of-care middleware, enabling additional features including a calculated hematocrit value and data management.
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Yourgene Health Receives HSA Approval for IONA Nx NIPT Workflow in Singapore
Yourgene Health plc has announced it has received Health Sciences Authority approval for its IONA® Nx NIPT Workflow in Singapore.
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