One Lambda gets CE mark approval in Europe for C1qScreen assay

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.

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."