One Lambda Receives CE Mark Approval

One Lambda Receives CE Mark Approval for C1qScreen Assay and Launches Assay in Europe

Assay cited in New England Journal of Medicine for use in determining impact on kidney graft survival.

November 05, 2013 05:43 PM Eastern Standard Time

CANOGA PARK, Calif.--(BUSINESS WIRE)--One Lambda Inc., part of Thermo Fisher Scientific and a leading producer of in vitro diagnostic products for the human leukocyte antigen (HLA) transplant community, has received CE mark approval in Europe for its C1qScreen™ assay. The assay, which was recently cited in the New England Journal of Medicine for its use in a kidney graft survival study (New England Journal of Medicine 360 (2013): 1215-1226), is now available in all CE mark-conforming countries, enabling European HLA clinics and laboratories to immediately use it during transplant diagnostic procedures.

“Introducing the C1qScreen assay to the European market is another milestone in OLI’s nearly 30-year history of transplant diagnostic leadership”

C1qScreen is a solid-phase assay that uses Luminex®-based single antigen beads to allow clinicians to further characterize donor-specific antibodies (DSA), distinguishing complement binding antibodies from non-complement binding antibodies. With this information, clinicians can better study the impact of the antibodies on clinical outcomes. Previous methodologies for determining complement binding DSA lacked the sensitivity and specificity C1qScreen offers. The minimally invasive assay accelerates sample-to-answer times, making it ideal for monitoring antibody progression and desensitization therapy.

A recent New England Journal of Medicine article, entitled “Complement-Binding Anti-HLA Antibodies and Kidney Allograft Survival,” showed that the presence of complement-binding donor-specific anti-HLA antibodies after transplantation more than quadruples patients’ risk of graft loss. These antibodies were also associated with higher rates of antibody-mediated rejection with more severe graft injury and, through the addition of complement-binding donor-specific anti-HLA antibody detection to traditional risk modeling, they were able to greatly improve stratification of patients at risk for graft failure.

“Introducing the C1qScreen assay to the European market is another milestone in OLI’s nearly 30-year history of transplant diagnostic leadership,” said Jar-how Lee, senior vice president of R&D, One Lambda. “A wealth of data from clinical research in the U.S., including the recent study cited in the New England Journal of Medicine, documents the promise of this new assay within the transplant field, and we’re pleased to make it more broadly available to transplant centers worldwide.”

About One Lambda, Inc.

One Lambda, Inc., now part of Thermo Fisher Scientific, the world leader in service science, 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.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.

Contacts

One Lambda Inc.

Ricardo Ordonez, 818-449-3271

Director of Public Relations

ricardo.ordonez@thermofisher.com

www.onelambda.com

 

Posted: November 2013


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