Corporate Banner
Satellite Banner
Genotyping & Gene Expression
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
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
Making Personalized Medicine a Reality
Groundbreaking technique developed at McMaster University is helping to pave the way for advances in personalized medicine.
Secret Phenotypes: Disease Devils in Invisible Details
Algorithmic deep phenotyping exposes masses of hidden traits and possible subtle genetic connections relevant to unseen influences on disease.
Hunting the Missing Link Between Genetics and the Environment
The International Phenome Centre Network (IPCN) works to transform healthcare through phenomics - the dynamic interactions between our genes and our environment.
Gene Limits Desire To Drink Alcohol
Research teams have identified a gene variant that suppresses the desire to drink alcohol.
'Lab on the Skin' for Sweat Analysis
Northwestern University researchers develop a low-cost wearable electronic device that collects and analyzes sweat for health monitoring.
Gut’s Microbial Community Influences Gene Expression
Study identifes gut microbes as mediators of host gene expression through the epigenome, regulating which genes are active in cells.
Novel Urine Test to Predict High-Risk Cervical Cancer
Preliminary studies affirm accuracy and potential cost savings to screen for virus-caused malignancy.
T Cell Channel Could Be Targeted to Treat Cancers
Researcher identify ion-channel found within T cells that could be targeted to reduce development of neck and head cancers.
SELECTBIO

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!