Satellite Banner
qPCR
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Biofortuna Receives FDA Clearance for MDx Freeze-Dried Kits

Published: Wednesday, February 26, 2014
Last Updated: Wednesday, February 26, 2014
Bookmark and Share
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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,900+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
Using Cancer Cells' Mass to Predict Treatment Response
A device has been developed that can detect changes in cell mass at a minute scale.
NVIDIA Awards $400k to Trailblazers in Cancer Research
NVIDIA Foundation furthers research that could lead to new and more targeted treatments with investments.
Malaria Parasite Evades Rapid Test Detection in Children
A study at the University of North Carolina found that gene deletion poses a threat to Malaria eradication efforts.
Working With Advanced Nanoimagers
Oxford Nanoimaging report on the work of early-adopters for their Nanoimager technology at the MRC Centre for Molecular Bacteriology and Infection.
History of Cells Told Through MEMOIR
MEMOIR technique developed by CalTech researchers enables the life history of cells to be read.
Nanoscale ‘Muscles’ Powered by DNA
Scientists have developed nanoscale "muscles" to integrate with custom DNA, that can force the material to bend, curl and flip.
Dissecting Bacterial Infections at the Single-Cell Level
Researchers have used single-cell analysis technology to provide new insight into the Salmonella infection process.
Peer Review is in Crisis, But Should be Fixed, Not Abolished
After the time to get the science done, peer review has become the slowest step in the process of sharing studies, and some scientists have had enough.
Cancer Stem Cells Fuel Tumor Growth
Mass. General, Broad Institute team finds strong evidence that cancer stem cells are important drivers of tumors in patients.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!