Linkage Biosciences, a global leader in the field of transplant diagnostics, announced that the LinkSēq Human Leukocyte Antigen (HLA) test is now available with CE mark.
LinkSeq can be used in Europe for In Vitro Diagnostics (IVD) applications in the fields of solid organ and stem cell transplantation.
LinkSeq is the first commercially available HLA testing platform developed for use with Real-Time PCR instrumentation that allows the identification of all classical HLA genes in a single test. For the more than 70,0001 patients waiting for organ transplants in Europe, rapid and reliable organ and tissue testing is critical.
"European regulatory approval represents an important milestone in Linkage Biosciences’ ongoing commitment to provide fast and accurate diagnostic products for the transplant community," said Zachary Antovich, CEO of Linkage Biosciences.
"For over a decade Linkage has focused on innovation and quality and so we are pleased to be operating according to the highest international standards."
The CE Mark was certified by LNE/GMED, the sole French accredited Notified Body for the European IVD Directive.
Additionally, the company’s Quality Management System was certified to ISO 13485 standards for the design, development, manufacture, and distribution of the LinkSeq products.
Linkage Biosciences is a molecular diagnostics company developing and marketing products that dramatically improve and expedite complex genetic testing.