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Pentosan Polysulfate Affords Pleotropic Protection to Multiple Cells and Tissues.
Pharmaceuticals (Basel)
March 2023
Raymond Purves Laboratory, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Faculty of Health and Science, University of Sydney at Royal North Shore Hospital, St. Leonards, NSW 2065, Australia.
Pentosan polysulfate (PPS), a small semi-synthetic highly sulfated heparan sulfate (HS)-like molecule, shares many of the interactive properties of HS. The aim of this review was to outline the potential of PPS as an interventional therapeutic protective agent in physiological processes affecting pathological tissues. PPS is a multifunctional molecule with diverse therapeutic actions against many disease processes.
View Article and Find Full Text PDFA Computational Framework for Comprehensive Genomic Profiling in Solid Cancers: The Analytical Performance of a High-Throughput Assay for Small and Copy Number Variants.
Cancers (Basel)
December 2022
Genomics Core Facility, Gemelli Science and Technology Park (G-STeP), Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Roma, Italy.
In January 2022, our institution launched a comprehensive cancer genome profiling program on 10 cancer types using a non-IVD solution named the TruSight Oncology 500 Assay provided by Illumina. The assay analyzes both DNA and RNA, identifying Single-Nucleotide Variants (SNV)s and Insertion-Deletion (InDel) in 523 genes, as well as known and unknown fusions and splicing variants in 55 genes and Copy Number Alterations (CNVs), Mutational Tumor Burden (MTB) and Microsatellite Instability (MSI). According to the current European IVD Directive 98/79/EC, an internal validation was performed before running the test.
View Article and Find Full Text PDFImplementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing.
Int J Lab Hematol
September 2022
CHU UCL NAMUR, Namur Thrombosis and Hemostasis Center (NTHC), Université Catholique de Louvain, Yvoir, Belgium.
On May 26th 2017 the European Parliament and the Council of The European Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous IVD directives (IVDD 98/79 EC). After several health and legal causes due to medical device malfunctions, the European Union (EU) extensively reviewed the previous regulatory, which had remained unchanged since 1998. Aim of the work is to analyse the effects of the new IVDR on the field of haemostasis and thrombosis testing with particular attention to specific clinical conditions.
View Article and Find Full Text PDFImplementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology.
Klin Monbl Augenheilkd
July 2022
Chemisches und Veterinäruntersuchungsamt Freiburg, Deutschland (1989 - 2020), EU-Referenzlaboratorium für Dioxine und PCB in Lebensmitteln und Futtermitteln, Freiburg, Deutschland.
The European Commission revised Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) to improve patient safety and take appropriate account of technical progress. With the new Regulation (EU) 2017/746 of April 5, 2017 on in vitro diagnostic medical devices (IVDR), high standards for the quality and safety of in vitro diagnostic medical devices (IVD) apply within the European Union. The IVDR is primarily aimed at manufacturers and suppliers of IVDs, but also has significant implications for medical diagnostic laboratories.
View Article and Find Full Text PDFIn vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme.
Vox Sang
January 2021
International Coordination, Regulatory Service, Paul-Ehrlich-Institut, Langen, Germany.
Blood transfusion remains a routine life-saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion-transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process.
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