IVDR
Top Five Articles on 360Dx Last Week: Mursla Bio's Liver Cancer Test; Use of LDTs Under IVDR; More
Last week, readers were most interested in a story about Mursla's liver cancer test for detecting microRNA and protein targets within extracellular vesicles.
MRC Holland Gets CE-IVDR Certification for Genetic Disorder Test
A number of the Dutch firm's products have received certification under Europe's In Vitro Diagnostic Regulation recently.
Inbiome Nabs IVDR Certification for 'Molecular Culture' Bacteria Test
The Amsterdam-based firm's PCR-based Molecular Culture ID test is used to detect more than 200 bacterial species, yielding results within five hours.
Bio-Rad Receives IVDR Certification for Infectious Disease Molecular Quality Controls
The firm's CT/NG Positive Run Control and STI Negative Run Control will be the first products CE-marked under IVDR.
MSInsight Nabs €1.6M in Seed Funding to Develop Microsatellite Instability Cancer Dx Software
The French cancer diagnostics startup plans to obtain regulatory approval for its MSIcare software as an in vitro diagnostic medical device for MSI cancers.
Nov 26, 2024