Technoclone receives US FDA marketing authorization for the first ADAMTS13 activity diagnostic test

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased to announce that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for Technozym ADAMTS13 Activity ELISA. This is the first ADAMTS13 activity test authorized by the FDA.

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).

“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”, says Nikolaus Binder, MD, PhD, CSO of Technoclone. “And today we are honored to address this unmet need for laboratories and patients across the U.S.”

“We are proud to partner with Technoclone to provide the first in vitro diagnostic assay for ADAMTS13 Activity in the U.S., leading the way for better access to this important parameter”, says Madeleine Burmester, President & CEO of DiaPharma.

About TTP 

TTP is a very rare, life-threatening blood clotting disorder caused from either a congenital or acquired absence/decrease of the von Willebrand factor-cleaving protease ADAMTS13.

About Technoclone 

Technoclone is committed to delivering high-quality test systems for in vitro diagnostics in hemostasis to its worldwide clientele. At Technoclone innovation is seen as its responsibility to address emerging complexities in the diagnosis of hematological and cardiovascular disorders. Since 1987, Technoclone has fostered close collaborations with global partners from academia, clinical laboratories, and industry, positioning itself at the forefront of anticipated diagnostic challenges in the years to come.

About DiaPharma 

DiaPharma Group, Inc. sells assay kits, reagents, and instrumentation for laboratory research and clinical applications in the fields of Bleeding and Clotting Disorders and Liver Injury. DiaPharma provides strong personal support and technical competence and experience to ensure customer expectations will be met or exceeded.

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

As a life sciences organization based in Vienna, would you like us to promote your news and events? If so, please send your contributions to news(at)