European Medicines Agency
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.
NEW YORK (GenomeWeb) – If AstraZeneca's PARP inhibitor olaparib is granted market approval by European and US healthcare authorities in the coming months, it would enable Myriad Genetics to begin marketing BRACAnalysis as a companion test for the first time.
Myriad Opens Tumor BRACAnalysis CDx Lab in Europe
NEW YORK (GenomeWeb) – Myriad Genetics announced today that it has established a European laboratory that will offer its Tumor BRACAnalysis CDx test to guide treatment with PARP inhibitors, namely AstraZeneca's olaparib.
Originally published Oct. 14.
MDx/CDx Focus: EMA Okays Perjeta; Published Study on Prolaris; HER2 Tests for Kadcyla Clear FDA
EMA Approves Roche/Genentech's Perjeta Roche has garnered approval from the European Medicines Agency for its HER2-positive metastatic breast cancer drug Perjeta.
Feb 1, 2012
Jan 27, 2011
Jun 17, 2010