Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

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
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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
The MaxSignal Colistin ELISA Test Kit from Bioo Scientific
Kit can help prevent the antibiotic apocalypse by keeping last resort drugs out of the food supply.
"Good" Mozzie Virus Might Hold Key to Fighting Human Disease
Australian scientists have discovered a new virus carried by one of the country’s most common pest mosquitoes.
Non-Disease Proteins Kill Brain Cells
Scientists at the forefront of cutting-edge research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s have shown that the mere presence of protein aggregates may be as important as their form and identity in inducing cell death in brain tissue.
Closing the Loop on an HIV Escape Mechanism
Research team finds that protein motions regulate virus infectivity.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
World’s First Therapeutic Venom Database
Open-source library describes nearly 43,000 effects on the human body.
Biologists Induce Flatworms to Grow Heads and Brains of Other Species
Findings shed light on role of a new kind of epigenetic signaling in evolution, could yield clues for understanding birth defects and regeneration.
Fat Cells Originating from Bone Marrow Found in Humans
Cells could contribute to diabetes, heart disease.
Scroll Up
Scroll Down
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos