Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test. Mechelen, Belgium, 02 June 2025 - ...

Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union (EU) Technical Documentation ...

With early detection of prostate cancer recognised as a critical part in reducing the disease’s mortality rate, PanGIA ...

and Class B and A Sterile devices). As of today, there are in fact only 12 appointed Notified Bodies for IVDs in Europe, so, ensuring that one takes on a new device is not an easy feat.

Illumina Inc. ILMN recently introduced PromoterAI, a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome. PromoterAI turns ...

Genedrive announced on Friday that it has secured CE certification for its CYP2C19 ID Kit under the European In Vitro Diagnostic Regulation (IVDR), allowing the pharmacogenetic test to be marketed and ...

Biocartis’ Idylla EGFR Mutation Test has secured the EU Technical Documentation Assessment and Quality Management System ...