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 blood from human newborn collected on filter paper. This qualitative analysis is performed by capillary electrophoresis with the CAPILLARYS 3 DBS automated instrument. This offer provides laboratories a gain in operational efficiency with high throughput and a full traceability from DBS card up to the result through a cybersecured environment.
“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” said Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality.