NEW YORK (GenomeWeb) – Linkage Biosciences today announced that it has received CE marking for the LinkSeq Human Leukocyte Antigen test.
The real-time PCR-based test covers all classical HLA genes and more than 12,000 alleles, and is now available in Europefor in vitro diagnostic applications for solid organ and stem cell transplantation, the South San Francisco-based firm said.
The CE mark was certified by LNE/GMED. Also, Linkage's quality management system was ISO 13485 certified for the design, development, manufacture, and distribution of LinkSeq products.
Linkage launched a wholly owned European subsidiary based in Geneva in April. The same month, it also announced a European distribution deal with Voden Medical Instruments for the LinkSeq test.