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Policy

Sebia Receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices

Sebia announced that it has received 510 clearance from the U.S. Food and Drug Administration for CAPILLARYS 3 DBS devices. Our solution is intended for the detection of normal hemoglobins and abnormal hemoglobins in blood from human newborn collected on filter paper.

April 5, 2024

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1 min read

Sebia Receives U.S. FDA Clearance for the FLC Kappa & Lambda Assays

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 the FLC Kappa & Lambda assays.

February 29, 2024

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2 min read

Deals

Sebia Acquires Orgentec Diagnostika

Sebia, a leading provider of clinical protein electrophoresis equipment and reagents for diabetes and oncology detection, announced the acquisition of specialty diagnostic leader ORGENTEC Diagnostika from Water Street Healthcare Partners, a strategic investor focused exclusively on healthcare, for an undisclosed amount.

June 30, 2021

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4 min read

Business

Sebia and Metafora biosystems form Strategic partnership to Develop Advanced In Vitro Diagnostics tests

Sebia, a world leader in diagnostics in the fields of multiple myeloma and chronic diseases, and Metafora biosystems (“Metafora”) today announced a strategic partnership to develop a portfolio of in-vitro diagnostics (IVD) solutions based on Metafora’s technology platform.

September 21, 2021

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3 min read

Sebia enters into agreement with Sanofi to develop multiple myeloma diagnostic test

Test will specifically adjust for isatuximab-induced interference in complete response assessment of multiple myeloma patients

January 9, 2020

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3 min read

TESARO Announces U.S. FDA Approval of VARUBI IV fo

FDA

Sebia Announces FDA Clearance for Its Hydrashift 2/4 Daratumumab Assay

This IVD reagent mitigates the daratumumab-mediated interference seen in Immunofixation results for patients with multiple myeloma treated with DARZALEX.

January 24, 2018

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2 min read

Business

Sebia Signs Agreement With Janssen Biotech To Develop A Multiple Myeloma IVD Test

January 30, 2017

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3 min read

Business

Sebia And Abingdon Health Ltd Sign Exclusive Global Distribution Agreement

July 5, 2016

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