Corporate Banner
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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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
New Method Promises to Speed Development of Food Crops
A new study addresses a central challenge of transgenic plant development: how to reliably evaluate whether genetic material has been successfully introduced.
Study Validates Analysis of Copy Number Variation in Miniaturized Reaction Volumes
Data shows that accurate and reproducible CNV results can be produced with IntelliQube using the Array Tape® consumable.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
Edited Stem Cells Offer Hope of Precision Therapy for Blindness
Findings raise the possibility of treating blinding eye diseases using a patient's own corrected cells as replacement tissue.
Parallel Single-Cell Profiling
New single-cell genomics protocol allows researchers to study links between DNA modifications (methylation) and the activity of a gene.
Pathogens Found in Iceman's Gut
Scientists discover Helicobacter pylori in the contents of Ötzi’s stomach along with some unexpected insights into the coexistence of man and bacterium.
Diagnosing Cancer from a Single Drop of Blood
What if a physician could effectively diagnose cancer from one drop of a patient’s blood?
Tracing a Cellular Family Tree
New technique allows tracking of gene expression over generations of cells as they specialize.
Accelerating Protein Evolution
A new tool enables researchers to test millions of mutated proteins in a matter of hours or days, speeding the search for new medicines, industrial enzymes and biosensors.
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Skyscraper Banner

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!