AESKU nDNA (Crithidia luciliae) now FDA cleared with HELIOS System

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AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

HELIOS All-in-One IFA platform

a very specific anti-dsDNA antibody test using the most automated system on the market: the HELIOS. This a great tool to help clinicians diagnose Lupus patients.

AESKU.GROUP – a science-focused manufacturer of autoimmune, allergy, and infectious disease diagnostics – received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

“Laboratories have continued to return to IFA testing ever since the 2009 ACR position statement, which asserts that IFA is the Gold Standard for systemic autoimmune disease screening. The HELIOS improves traceability and turnaround time and eliminates the subjectivity and labor-intensiveness of immunofluorescence assays, so labs can follow the ACR recommendations and ultimately improve the quality of patient testing," said Dr. Torsten Matthias, founder and CEO of the AESKU.GROUP.

“Laboratories performing IFA will be able to screen for ANA’s and then reflex to a very specific anti-dsDNA antibody test using the most automated system on the market: the HELIOS. This a great tool to help clinicians diagnose Lupus patients.

We look forward to making this kit available on the HELIOS to US clinical laboratories with the help of Grifols, our exclusive distribution partner in the US,” said Bruno Larida, Vice-President AESKU. INC.

The HELIOS is a revolutionary platform that both processes and analyzes patient immunofluorescence (IFA) samples in a single run. It is the first and only clinical platform to offer this level of IFA automation, overcoming the previous limitations of IFA testing and letting users return to the gold-standard method for Autoimmunity screening. Over 300 HELIOS systems are in clinical use worldwide, in over 40 countries including the USA.
The HELIOS system and associated FDA cleared kits will be displayed at the American Association of Clinical Chemistry meeting.

For additional information please visit http://www.whatishelios.com

About AESKU. Diagnostics GmbH & Co. KG
AESKU.GROUP (http://www.aesku.com) is headquartered in Wendelsheim, Germany and is made up of the following divisions: AESKU.DIAGNOSTICS, AESKU.THERAPY (Autoimmune Therapies), AESKU.SYSTEMS (Lab Automation), AESKU.INC (North American headquarters in Oakland, CA), AESKU.NY (IFA Manufacturing and Research in Buffalo, NY).

Besides its own outstanding commitment to research and development, AESKU.GROUP initiated and supports the AESKU.KIPP INSTITUTE, a non-profit organization, primarily active in basic research and interdisciplinary knowledge transfer in autoimmunity.

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Benjamin Lack
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