19 March 2014
Biofortuna receives FDA clearance of its SSPGo™ line of HLA molecular diagnostic freeze-dried kits
Biofortuna, a UK based molecular diagnostics company with proprietary freeze drying (lyophilizing) technology, has received FDA 510K clearance for its line of SSPGo™ HLA PCR kits. The SSPGo HLA Typing Kits are qualitative DNA-based kits for determining HLA alleles in low to intermediate resolution. The kits are designed for transplantation genotyping and identification of genes which may be associated with various genetic conditions.
In 2011, Biofortuna announced an exclusive global distribution agreement with Abbott for its SSPGo™ kits. Until now, the kits were CE marked and only distributed in Europe and Asia Pacific. Now with FDA clearance, kits will be available in early 2014 in the United States.
Dr Simon Douglas, CEO of Biofortuna stated “I am delighted that Biofortuna has received FDA clearance of its SSPGo™ kits. This significant milestone will allow our partner, Abbott, to distribute the world’s first freeze dried HLA typing kits in the U.S.”
Biofortuna’s unique freeze dried kits contain everything required for PCR, including Taqpolymerase. The kits are stable at ambient temperature and convenient, only requiring the end user to add DNA to a freeze dried PCR mix prior to amplification and detection. They can be stored and transported at ambient temperature, eliminating the need for refrigerators, freezers and temperature controlled shipping. In addition, the kits may help to provide cost savings to the end user performing conventional HLA testing by helping reduce labor, consumables and the potential for pipetting error and contamination.
Biofortuna Ltd also offers a product development contract service using its freeze dried proprietary manufacturing capabilities and is working with a wide range of companies in the diagnostic and life science sectors.