www.fdanews.com/articles/171580-linkage-biosciences-snags-ce-mark-for-first-pcr-hla-test
Linkage Biosciences Snags CE Mark for First PCR HLA Test
June 9, 2015
Linkage Biosciences said Tuesday that its LinkSeq human leukocyte antigen test has won CE mark approval.
The product is the first commercially available HLA testing platform compatible with real-time polymerase chain reaction technology, which enables identification of all classical HLA genes in one test, the company claims.
LinkSeq is indicated for organ and tissue evaluation for the over 70,000 European patients awaiting transplants, as well as for in vitro diagnostic applications.
South San Francisco, Calif.-based Linkage Biosciences was founded in 2004. — Jason Scott