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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
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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.)

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