A high-throughput Capillary Electrophoresis solution for newborn screening of hemoglobin disorders.
Sebia receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices
The next generation instrument for screening hemoglobin disorders in newborns.
Lisses, France, April 5th, 2024 – Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.
Our solution is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart’s) in human neonatal blood collected on filter paper. This qualitative analysis, performed by capillary electrophoresis with the CAPILLARYS 3 DBS automated instrument, is used for the screening and the aid to diagnosis of hemoglobinopathies.
As a global leader for hemoglobinopathy testing, Sebia is expanding its portfolio in the United States with this innovative solution, which can be easily integrated into the laboratory workflow significantly reducing manual intervention while ensuring comprehensive traceability. This will help laboratories to make timely and accurate decisions for newborns