NEW YORK (360Dx) – The AESKU Group said today that the US Food and Drug Administration cleared the company's vasculitis test for use on the Helios automated IFA system.
Specifically, the FDA cleared AESKUSLIDES ANCA Ethanol and ANCA Formalin on the automated immunofluorescence assay system. In a statement, AESKU Vice President Bruno Larida said that when a hospital needs to distinguish adeno-associated viruses from infection, "automated IFA will save precious minutes in a very critical situation and help physicians make the appropriate therapeutic decision."
The Helios platform processes and analyzes patient samples in a single run, the company said, adding more than 300 of the systems are being used clinically worldwide.
Last month, the FDA cleared AESKUSLIDES nDNA for diagnosing lupus.