Technoclone, a producer of diagnostic tests, equipment, and research products in the field of blood clotting, and its exclusive distributor in the U.S., DiaPharma Group announced 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 company says.
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.”
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.
“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.
Further reading: Ad Astra Diagnostics’ Hematology Analyzer Gets 510(k) Clearance
