Regulatory News:
Olerup SSP, a wholly owned subsidiary of LinkMed (STO:LMED), has had its Taq-polymerase-free HLA typing kit registered and cleared by the FDA. This means that Olerup SSP’s entire product range for HLA typing, with or without Taq polymerase, can now be marketed and sold to a greater number of healthcare centers in North America. The U.S. is the single largest market for HLA typing and represents over 40 percent of the global tissue typing market. Olerup SSP’s HLA typing kit with Taq polymerase has been approved by the FDA for sale in the United States since March 2009.
“Olerup SSP’s products are currently being re-launched in the U.S. market since Olerup International took over the distribution of products from Qiagen, so the FDA decision is very timely,” said Olle Olerup, founder and CEO of Olerup SSP.
FDA registration is furthermore an important step in working up a market in the U.S. and opens the door for sales in South America.
The typing kit is marketed and sold by Olerup SSP’s distributor Olerup International, a company that acquired the distribution rights from the previous distributor Qiagen this summer. Olerup International has two wholly owned subsidiaries, Olerup GmbH based in Vienna, and Olerup Inc based in West Chester, Pennsylvania, from where the company manages marketing and sales in the North American market. Olerup Inc. is also responsible for sales of the AbSorber’s product XM-ONE® in the U.S. Olerup International is owned by LinkMed, together with the Norwegian biotechnology company NorDiag and Olle Olerup’s company SSP Primers.