Technoclone Nabs FDA De Novo Authorization for ADAMTS13 Assay

Original from: 360dx

Diagnostic test maker Technoclone on Tuesday said it has secured US Food and Drug Administration de novo marketing authorization for a test that is used to aid the diagnosis of a rare, life-threatening blood-clotting disorder.

The Vienna-based firm said its Technozym ADAMTS13 Activity ELISA is used for the qualitative determination of von Willebrand factor-cleaving protease ADAMTS13 activity in platelet-poor citrated plasma. The results are used with other clinical and laboratory findings to aid in the diagnosis of thrombotic thrombocytopenic purpura in adult and pediatric patients who are being evaluated for the thrombotic microangiopathy group of rare disorders.

"In line with our commitment to provide ADAMTS13 diagnostics globally, we are excited about this milestone, having the first ADAMTS13 activity test granted with marketing authorization by the FDA," Technoclone CSO Nikolaus Binder said in a statement.

West Chester, Ohio-based DiaPharma Group will be the exclusive US distributor for the assay. DiaPharma is a seller of assay kits, reagents, and instrumentation for clinical and research applications related to bleeding and clotting disorders and liver injury.

Financial and other terms of the deal were not disclosed.

​

Source: Technoclone Nabs FDA De Novo Authorization for ADAMTS13 Assay