You are here
THE ENTIRE PRODUCT RANGE FOR HLA TYPING NOW FDA APPROVED FOR SALES IN THE U.S
15 September 2009: LinkMed AB, one of NorDiag's partners in the subsidiary Olerup International AB, announces today that Olerup SSP, a wholly owned subsidiary of LinkMed, has received FDA registration and approval on its HLA typing kit with or without Taq polymerase. This implies that the entire product range to be distributed by Olerup International AB within HLA typing can now be marketed and sold to a greater number of hospitals and clinical laboratories in North America. The US is the single largest market for HLA typing and represents more than 40% of the global market.
"This will strengthen Olerup International's position further in the market and constitutes an important step to cover and fulfill customers' needs in the entire American market, and support the strong sales estimate we have communicated for the second half of 2009", says CEO Mårten Wigstøl. He also emphasizes that the FDA-registration may open the door for sales in South America. The partnership is strategic for NorDiag, and Olerup International's product range will be further strengthened by additional sales of NorDiag's "Arrow" automated sample preparation solutions in this market".
Olerup SSP is the world leader in the development of kits for genomic HLA typing, which is used prior to transplantions to match donors with recipients. Better matching reduces the risk of complications following transplantation. HLA typing is a standard procedure in bone marrow transplantation (hematopoietic stem cell transplantation) but is also used in organ transplantations (kidney, lung, heart and others).
In addition to NorDiag and Linkmed, Olle Olerup's company SSP Primers is a part-owner in Olerup International.
Contact:
CEO Mårten Wigstøl, phone +47 911 65775
Read the notice in Norwegian here