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.
Agilent Technologies Gains Expanded IVDR Certification for PD-L1 CDx
The test has been certified for use in the EU to help guide the treatment of early-stage non-small cell lung cancer and previously untreated advanced melanoma.
Agilent Technologies Nabs IVDR Certification for PD-L1 CDx
The PD-L1 IHC 28-8 PharmDx test is used to provide information on PD-L1 expression as a biomarker for patient response to therapies containing anti-PD-1 antibodies.
Yourgene Health Cystic Fibrosis Assay Receives IVDR Certification
The assay uses amplification-refractory mutation system (ARMS) technology and genetic analyzers to detect the 50 most common CF mutations in European ancestry populations.
Agendia Gets CE-IVDR Certification for MammaPrint, BluePrint FFPE Breast Cancer Tests
The assays are versions of Agendia’s MammaPrint and BluePrint tests that use formalin-fixed paraffin-embedded tissue samples instead of fresh tissue.