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

One Lambda, Inc., Now Part of Thermo Fisher Scientific, Obtained FDA Clearance for HLA Fusion Software Version 3.0

Published: Sunday, February 10, 2013
Last Updated: Sunday, February 10, 2013
Bookmark and Share
Companion software to molecular typing and antibody screening products obtains FDA clearance

One Lambda, Inc., now part of Thermo Fisher Scientific, a leading producer of medical diagnostic products for the HLA transplant community, has announced that HLA Fusion Software version 3.0, a companion software to molecular typing and antibody screening products, has obtained FDA clearance by the FDA and a Health Canada License by the Ministry of Health Canada.

All of One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing and antibody screening results. Product families used in conjunction with HLA Fusion include the market-leading LABScreen® (antibody detection) and LABType® (HLA Typing) products, in addition to LAT™, LCT™, FlowPRA®, and MicroSSP™ products. The HLA Fusion Software version 3.0 provides all the tools and applications from version 2.0 and its related Service Packs, support with Luminex® xPONENT® 3.1 acquisition software for LABScan® 100, and more.

In response to obtaining clearance, One Lambda’s Director of Marketing, Stewart Han, expressed his excitement by saying, “We are pleased to see another great accomplishment from our software development team. Their hard work and determination has created brilliant analysis software that continues to help position our molecular typing and antibody screening products at the forefront of transplant diagnostics and improve the quality of patient life.” Gouri “GS” Jha, Director of Information Systems and Commercial Software Products also stated, “We are extremely proud to have been awarded FDA clearance for HLA Fusion software 3.0 and it is gratifying that the hard work and dedication of our team has paid off by delivering a powerful new tool for the transplant community.“

(Limitations: All One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing results. However, any clinical or diagnostic results must be carefully reviewed by a person qualified in HLA typing to assure correctness. This software may be used to aid in suggesting results, but should not be used as the sole method for determining reportable results. This software is meant as a laboratory aid, not as a source of definitive results. The software design does not mitigate hazards associated with the software. The laboratory director or technologist trained in histocompatibility testing is required to review all data to detect any problems with the software.)


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 3,100+ scientific posters on ePosters
  • More Than 4,500+ 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.

Related Content

Native Mobile Capabilities Added to Thermo SampleManager
One of world’s most widely deployed LIMS continues to add functionality that modern labs require.
Monday, March 14, 2016
Thermo, Children’s Hospital Los Angeles Partner
Children’s Hospital Los Angeles (CHLA) and Thermo Fisher Scientific have agreed to develop a next-generation sequencing (NGS)-based panel designed specifically for pediatric cancer research. The assay would be CHLA’s first NGS panel designed to target biomarkers associated with childhood cancers.
Friday, February 19, 2016
Thermo Scientific Gemini Handheld Chemical Analyzer Wins R&D 100 Award
Two-in-one portable device also earns Editor’s Choice in Analytical/Test category for 2015 by R&D Magazine.
Thursday, November 26, 2015
Thermo Scientific Signs Agreement with Novartis, Pfizer
Universal test designed for non-small cell lung cancer supports multiple drug development programs.
Thursday, November 26, 2015
Thermo Scientific Opens New GMP Clinical Services Facility in Singapore
New regional BioPharma Services hub offers larger operational space and advanced equipment to meet increasing clinical supply needs for pharma and biotech customers.
Saturday, November 21, 2015
Thermo Scientific Manufacturing Site to Meet Guidelines for 18385 Certification
A new standard proposed by the International Organization for Standardization.
Thursday, October 15, 2015
Thermo Fisher Scientific Announces Winners of 2016 Winter Conference Awards in Plasma Spectrochemistry
Independent committee recognizes significant contributions in plasma spectrochemistry.
Wednesday, September 23, 2015
Thermo Fisher Scientific Receives IVDD CE Mark for LC-MS Products
Now available to clinical laboratories in Europe for general in vitro diagnostic use.
Friday, September 11, 2015
Thermo Launches Geneticon
Thermo Fisher Scientific launches GenetiCon, a virtual resource showcasing the real-life science behind superheroic powers and more.
Tuesday, July 07, 2015
Thermo Fisher Agrees to Buy Alfa Aesar for $403M
The company announced a definitive agreement to buy the research chemical manufacturer for $403 million.
Friday, June 26, 2015
Ebola Sequencing Data Released to Global Research Community Online
To curb further spread of Ebola in Sierra Leone, a team of scientists that is part of an international, multi-organizational effort has released their first dataset of the virus’ genetic structure online.
Wednesday, June 03, 2015
Thermo's NGS Platform Selected for Nationwide Clinical Research Program
National Cancer Institute-MATCH trial to sequence thousands of tumor samples using Ion Torrent targeted sequencing technology.
Monday, June 01, 2015
Thermo Strengthens Bioprocessing Offering with Advanced Scientifics Acquisition
Thermo Fisher Scientific has acquired Advanced Scientifics, Inc., a global provider of single-use technologies for customized bioprocessing solutions, for $300 million in cash.
Friday, February 06, 2015
Thermo Fisher Q3 Revenues up 31 Percent
Thermo Fisher announced that revenues grew 31% to $4.17 billion for the third quarter ended September 27, 2014.
Thursday, October 23, 2014
Thermo Scientific Announces Listing of the Ion PGM Dx System
Company has completed the listing with the U.S. FDA as class II medical device.
Saturday, September 20, 2014
Scientific News
The Rise of 3D Cell Culture and in vitro Model Systems for Drug Discovery and Toxicology
An overview of the current technology and the challenges and benefits over 2D cell culture models plus some of the latest advances relating to human health research.
Grant Supports Project To Develop Simple Test To Screen For Cervical Cancer
UCLA Engineering announces funding from Bill and Melinda Gates Foundation.
Injecting New Life into Old Antibiotics
A new fully synthetic way to make a class of antibiotics called macrolides from simple building blocks is set to open up a new front in the fight against antimicrobial drug resistance.
Insight into Bacterial Resilience and Antibiotic Targets
Variant of CRISPR technology paired with computerized imaging reveals essential gene networks in bacteria.
Advancing Protein Visualization
Cryo-EM methods can determine structures of small proteins bound to potential drug candidates.
Alzheimer’s Protein Serves as Natural Antibiotic
Alzheimer's-associated amyloid plaques may be part of natural process to trap microbes, findings suggest new therapeutic strategies.
Slime Mold Reveals Clues to Immune Cells’ Directional Abilities
Study from UC San Diego identifies a protein involved in the directional ability of a slime mold.
How Do You Kill A Malaria Parasite?
Drexel University scientists have discovered an unusual mechanism for how two new antimalarial drugs operate: They give the parasite’s skin a boost in cholesterol, making it unable to traverse the narrow labyrinths of the human bloodstream. The drugs also seem to trick the parasite into reproducing prematurely.
Illuminating Hidden Gene Regulators
New super-resolution technique visualizes important role of short-lived enzyme clusters.
Supressing Intenstinal Analphylaxis in Peanut Allergy
Study from National Jewish Health shows that blockade of histamine receptors suppresses intestinal anaphylaxis in peanut allergy.
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
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!