WebThe risk presented by an IVD medical device also depends, in part, on its intended user(s), its mode of operation, and/or technologies. 1.3. Scope This document is applicable to IVD device products that fall within the definition of an IVD medical device as defined in First Schedule of the Health Products Act (Act). WebJan 19, 2024 · Cambridge, United Kingdom – 19 January 2024 - Congenica, a UK-based digital health company that enables the rapid analysis and interpretation of genomic data, …
Breakthrough Devices Program FDA
WebThe STS panel covers the coding regions and splicing junctions (±25 bp min) of 42 genes, associated but not limited to lung and colorectal cancers, melanoma and glioma. It … WebJul 30, 2024 · DNA extraction from formalin fixed and paraffin embedded tissue was performed with the Maxwell CSC system (CE-IVD, Promega). Next generation sequencing … cst time difference with pst
TruSight Oncology 500 Portfolio - Illumina, Inc.
WebOne Goal. Introducing TruSight Oncology Comprehensive (EU), the first CE-marked IVD test kit for comprehensive genomic profiling based on DNA and RNA that consolidates … WebIn this video, we demonstrate how to set up and run DRAGEN TruSight Oncology 500 (TSO500) v1.1.1 analysis on the Illumina® Connected Analytics (ICA) platform... WebOur TSO500 NGS seravices provide pan-cancer genomic biomarker analysis of SNVs, InDels, CNVs, Fusions, TMB, and MSI to enable: Discovery and verification of the presence of … early-onset dementia symptoms mayo clinic