FDA Approves AESKU’s Automated Diagnostic Tests for ANCA-associated Vasculitis

The U.S. Food and Drug Administration has approved two automated diagnostic tests that AESKU.Group developed for ANCA-associated vasculitis.

AESKU used its HELIOS technology to develop the tests. HELIOS is the only diagnostic tool capable of both processing and analyzing a patient’s blood sample via an immunofluorescence assay (IFA) in a single run, the German company said in a press release.

The tests use antibodies and fluorescence to detect markers of ANCA-associated vasculitis in blood. Because the tests pair immune-system-produced antibodies with fluorescence, the approach is called immunofluorescence.

The FDA has now approved four of the company’s HELIOS-based tests. This gives it the largest menu of authorized immunofluorescence diagnostic tests that are available, it said.

Medical laboratories in the United States and more than 40 other countries are now using 300 HELIOS diagnostic testing systems, AESKU said in the release.

“Integrated design and pattern recognition software” are reasons why HELIOS can offer top-quality immunofluorescence diagnostic tests that “ultimately improve patient outcomes,” said Torsten Matthias, the company’s founder and CEO.

“ANCA-associated vasculitis assays are one of the rare STAT [short-time turnaround] autoimmune tests,” said Bruno Larida, the vice president of AESKU.Inc. “When a hospital needs to distinguish between AAV [ANCA-associated vasculitis] and infection, automated IFA will save precious minutes in a very critical situation and help physicians make the appropriate therapeutic decision,” he said.

“The HELIOS, combined with our large IFA portfolio and AESKU.LAB automation management tool, can easily fit into a distributed healthcare system, bringing testing closer to patients and improving access,” Larida said. “We look forward to making the kit and system available to US healthcare providers with the help of Grifols, our exclusive distribution partner in the US,” he added.

AESKU will be showcasing both the HELIOS system and the company’s FDA-approved diagnostic test kits at the American Association of Clinical Chemistry’s 70th annual meeting in Chicago, July 29-Aug. 2.