Linkage Biosciences Announces CE Mark for World's First Real-Time PCR HLA Test
SAN FRANCISCO, June 9, 2015 /PRNewswire/ -- Linkage Biosciences, a global leader in the field of transplant diagnostics, announced today that the LinkSēq™ Human Leukocyte Antigen (HLA) test is now available with CE Mark. LinkSēq can be used in Europe for In Vitro Diagnostics (IVD) applications in the fields of solid organ and stem cell transplantation.
LinkSēq 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 LinkSēq products.
About Linkage Biosciences
Linkage Biosciences is a molecular diagnostics company developing and marketing products that dramatically improve and expedite complex genetic testing. LinkSēq is the company's flagship technology that provides the fastest and simplest method of Human Leukocyte Antigen (HLA) testing on the market, covering all classical HLA genes and over 12,000 alleles in a single test. LinkSēq technology utilizes a proprietary assay methodology including reagents and software in combination with standard Real-Time PCR hardware to simplify the determination of complex genetic sequences. The company is headquartered in South San Francisco, California. To learn more please visit www.linkagebio.com
1Council of Europe European Committee on Organ Transplantation, International figures on organ, tissue & hematopoietic stem cell donation & transplantation activities (September 2014 newsletter): https://www.edqm.eu/medias/fichiers/newsletter_transplant_vol_19_no_1_september_2014.pdf
Copyright 2015. Linkage Biosciences, Inc. All rights reserved.
Linkage Biosciences and LinkSēq are trademarks of Linkage Biosciences, Inc.
Media Contact:
Matthew Frome
+1 415 346 5262
media@linkagebio.com
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