One Lambda, a part of Thermo Fisher Scientific, has obtained CE Mark approval for its C1qScreen assay in Europe.
Utilizing Luminex-based single antigen beads, the C1qScreen solid-phase assay allows clinicians to further characterize donor-specific antibodies, distinguishing complement binding antibodies from non-complement binding antibodies.
With the characterization of donor-specific antibodies, clinicians can better study the impact of the antibodies on clinical outcomes.
C1qScreen offers both sensitivity and specificity.
This assay speeds up sample-to-answer times, making it ideal for monitoring antibody progression and desensitization therapy.
Recently, the minimally invasive has been cited in New England Journal of Medicine for use in determining the impact on kidney graft survival.
One Lambda R&D senior vice president Jar-how Lee noted introducing the C1qScreen assay to the European market is another milestone in the company’s nearly 30-year history of transplant diagnostic leadership.
"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," Lee added.
With this approval, C1qScreen assay will be now available in all CE Mark-conforming countries, enabling European HLA clinics and laboratories to immediately use it during transplant diagnostic procedures.