NEW YORK (360Dx) – AESKU.Group said today that has received 510(k) clearance from the US Food and Drug Administration for its AESKUSLIDES nDNA for use with the company's Helios automated IFA system.
The assay is for diagnosing lupus and is the second immunofluorescence assay cleared by the FDA for the Helios platform, following the clearance of the ANA Hep-2 assay in 2016, AESKU.Group said.
Grifols, the group's exclusive distribution partner in the US, will help make the kit available to US clinical labs, AESKU Vice President Bruno Larida said in a statement.
AESKU.GROUP — headquartered in Wendelsheim, Germany and comprising six divisions, including AESKU:Diagnostics — manufactures autoimmune, allergy, and infectious disease diagnostics. The Helios system automates the pipetting and image capturing of IFA tests, according to the company's website.
"Laboratories performing IFA will be able to screen for [antinuclear antibodies] and then reflex to a very specific anti-dsDNA antibody test using the most automated system on the market: the Helios," Larida said.