AESKU Group is a research-focused supplier of innovative products and services for the early detection, diagnosis and prognosis of autoimmune diseases. It announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new HELIO automated immunofluorescence (IFA) system with AESKUSLIDES ANA HEp-2-Gamma Assay. The HELIOS is a new revolutionary platform that employs automated IFA technology to process and analyze patient samples. It is the first clinical diagnostics platform to offer automation of the IFA process to this extent.
The HELIOS is an automated system for immunofluorescence processing with image capturing with an integrated fluorescence microscope and software. Results must be confirmed by a trained user. It is the first and only system that performs this process continuously from start to finish. The HELIOS fully addresses and overcomes the known limitations of IFA, enabling the user to adopt it as the autoimmunity reference screening method. The HELIOS is currently in use in 29 countries worldwide.
The HELIOS automated IFA system is initially cleared for use with AESKUSLIDES ANA HEp-2-Gamma assay and the next assays to be cleared are: ANCA, Crithidia Luciliae and Tissue Sections.