EMA
Invivoscribe LeukoStrat CDx Gets CE Mark, EMA Approval
The PCR-based test is designed to help in the selection of acute myelogenous leukemia patients eligible for certain treatments.
NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software
The NewStem Software Diagnostic Device screens human haploid embryonic stem cells for gene mutations involved in chemotherapy resistance.
MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
Dako Declares CE Mark for PD-L1 Companion Diagnostic for Lung Cancer Immunotherapy
The test will identify NSCLC patients with PD-L1 expression who are likely to benefit from Merck's Keytruda, which has received a positive opinion from European regulators.