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Biofortuna Gets FDA OK for Freeze Dried HLA Kits

NEW YORK (GenomeWeb News) — Biofortuna said today that it has received 510(k) clearance from the US Food and Drug Administration for its SSPGo HLA PCR kits.

The qualitative DNA-based kits are used to determine human leukocyte antigen alleles in low to intermediate resolution, and are designed for transplantation genotyping and identification of genes that may be associated with various genetic conditions, the UK-based company said.

Biofortuna's freeze dried kits contain everything required for PCR, including Taq polymerase, and are stable at ambient temperature, eliminating the need for refrigerators, freezers, and temperature-controlled shipping. The kits only require the user to add DNA to the freeze dried PCR mix prior to amplification and detection.

In 2011 Biofortuna announced an exclusive global distribution agreement with Abbott for the SSPGo kits, and the companies expanded that agreement in 2012.

Until now, the kits were CE marked and only distributed in Europe and Asia Pacific. With FDA clearance, the kits will now be available early this year in the US, Biofortuna said.