AESKU Receives FDA 510(k) Clearance for HELIOS AUTOMATED IFA SYSTEM with AESKUSLIDES ANA HEp-2-Gamma

AESKU.GROUP, a research-focused supplier of innovative products and services for the early detection, diagnosis and prognosis of autoimmune diseases, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new HELIOS AUTOMATED IFA SYSTEM with AESKUSLIDES ANA HEp-2-Gamma Assay. The HELIOS is a new revolutionary platform that employs automated immunofluorescence (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.

"We are thrilled about receiving FDA clearance for this significant new technology. This unique system will improve turnaround time, eliminate subjectivity and the labor-intensive processes involved in Immunofluorescence assays and finally improve the quality of patient testing. The development of the HELIOS system is a great example of AESKU's commitment to providing useful tools that enable laboratories to improve testing methods, maximize efficiencies and lower costs. To further our commitment to the US market, we have opened manufacturing and R&D facilities in the Buffalo Niagara Medical Campus. We are now able to give our customers even more technical support and timely products manufactured in the US. With the HELIOS, darkrooms are no longer required," said Dr. Matthias, founder and CEO of the AESKU.GROUP.

“In 2009, the American College of Rheumatology (ACR) published a position statement, asserting that IFA was the Gold Standard for screening for systemic autoimmune disease. Since then, Dr. Matthias and the AESKU.GROUP have strived to develop a platform that would address the needs of clinical laboratories for more automation and less subjectivity in IFA. We look forward to making it available to US clinical laboratories with the help of Grifols, our exclusive distributor in the US,” said Bruno Larida, Vice-President AESKU. INC and US Country Manager.

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.

The system is displayed at the American Association of Clinical Chemistry meeting and is now available in the U.S.

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