Sebia  

1705 Corporate Drive
Suite 400
Norcross,  GA  30093

United States
http://www.sebia.com/en-us

• Booth: 2449

Sebia is a global leader in specialty IVD instruments and assays, offering capillary and agarose gel separation technologies and autoimmune and infectious disease testing. Sebia’s capillary electrophoresis portfolio is led by the flagship CAPILLARYS 3 Family of systems, providing full walkaway capability and workload flexibility on a multi-assay platform; adding a high-capacity tube loader allows for added specimen capacity and work-cell productivity. For autoimmunity, Sebia offers the fully automated, random access Alegria 2* immunoassay platform utilizing a unique Monotest Strip Technology, along with the dIFine® automated microscope and dIFine P30 processor, a digital IFA imaging and interpretation system with an efficient walkaway benchtop instrument for slide processing. For infectious disease testing, Sebia offers a broad menu of ELISA and Alegria 2* assays highlighted by our pioneering Borrelia Modified Two-Tiered Testing (MTTT) algorithm. *Not available in the US.

 Press Releases

• Sebia receives U.S. FDA Clearance for the FLC Kappa & Lambda assays (May 31, 2024)

  Sebia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the FLC Kappa & Lambda assays.

  These are the first EIA tests receiving 510(k) from the FDA for the quantitative detection of both kappa and lambda free light chains (FLC) in human serum specimens, intended for both aid of diagnosis and monitoring of #Multiple Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.

• Sebia receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices (May 31, 2024)

  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.