One Lambda, Inc., Now Part of Thermo Fisher Scientific, Obtained FDA
Clearance forHLA Fusion Software Version 3.0
CANOGA PARK, Calif. -- January 23, 2013
One Lambda, Inc., now part of Thermo Fisher Scientific, a leading producer of
medical diagnostic products for the HLA transplant community, is pleased to
announce 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.)
About One Lambda, Inc.
One Lambda, Inc., is the worldwide leader in HLA typing and antibody detection
assays. One Lambda is known for its commitment to quality, service, and
innovation. The company develops and distributes several lines of HLA typing
and antibody detection tests utilizing serological, molecular, ELISA, Flow,
and Luminex xMAP technologies. In addition, One Lambda also manufactures
laboratory instrumentation and computer software that are used to simplify and
automate testing procedures and final test evaluations. For more information,
please visit www.onelambda.com.
One Lambda, Inc.
Stewart Han, Director of Marketing
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