Technoclone Receives US FDA Marketing Authorization for the First ADAMTS13 Activity Test
Posted on: March 5, 2024
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Technozym ADAMTS13 Activity granted marketing authorization by the FDA
DiaPharma and Technoclone are pleased to announce the FDA De Novo classification grant and authorization to market the first in vitro diagnostic (IVD) assay for the qualitative determination of ADAMTS13 activity.
The Technozym ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma. The assay is intended to be used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA).
DiaPharma is proud to partner with Technoclone to lead the way for better access to this important test, addressing an unmet need for laboratories and patients across the U.S.
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