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Biofortuna Receives FDA Clearance for MDx Freeze-Dried Kits

Published: Wednesday, February 26, 2014
Last Updated: Wednesday, February 26, 2014
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Company receives 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.

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