CE mark
Paige Gets CE-IVD Mark, UK Regulatory Approval for Breast Cancer Biomarker Software
The software is designed to detect HER2 expression based on protein and mRNA levels on digital images of tissue samples.
Biocartis Nabs CE Mark for Lung Cancer Test
The firm's panel detects ALK, ROS1, RET, and METex14 skipping, actionable targets relevant in non-small cell lung cancer, in three hours.Â
Nonagen Gets CE Mark for Bladder Cancer Immunoassay
The protein-based test, based on xMap technology from Luminex, is designed to measure 10 protein biomarkers in a single urine sample.
Imagia Canexia Health Garners CE-IVD Mark for Comprehensive Cancer Testing Platform
Having met the requirements for self-certification, the company is readying to deploy its Imagia Canexia Health Insights Platform to oncologists in Europe.
Burning Rock, Stratipath, Genetron Receive CE Marks for Cancer Tests
Genetron and Burning Rock said that their cancer tests received CE marking, while Stratipath said its software for the risk stratification of breast cancers was CE marked.