FDA clears Automated Vasculitis Test from AESKU
AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System
(Wendelsheim, Germany / Oakland, California) 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 ANCA Ethanol, and ANCA Formalin with the new HELIOS AUTOMATED IFA SYSTEM. Next to be submitted are esophageal and tissue section slides. Read more...
“These are 3rd and 4th FDA cleared assays on the HELIOS, after ANA HEp-2 [in 2016] and nDNA [cleared last month], thanks to our great Regulatory Affairs team at AESKU. With four kits, the HELIOS has the largest FDA cleared IFA menu of any platform and is the only sample-in/result-out system, with half the footprint. Through integrated design and pattern recognition software, the HELIOS system solves the subjectivity, labor, and traceability problems of IFA so laboratories can use the highest quality tests and ultimately improve patient outcomes." said Dr. Matthias, founder and CEO of the AESKU.GROUP.
“ANCA-associated vasculitis assays are one of the rare STAT autoimmune tests. When a hospital needs to distinguish between AAV and infection, automated IFA will save precious minutes in a very critical situation and help physicians make the appropriate therapeutic decision. The HELIOS, combined with our large IFA portfolio and our automation management tool can easily fit into a distributed healthcare system bringing testing closer to patients, and improving access. 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.” said Bruno Larida, Vice-President AESKU. INC.
The HELIOS is a revolutionary platform that both processes and analyzes patient 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 its FDA cleared kits will be displayed at the American Association of Clinical Chemistry meeting.
nDNA (Crithidia luciliae) now FDA cleared with HELIOS System
AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM
(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP 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 laborintensiveness of immunofluorescence assays, so labs can follow the ACR recommendations and ultimately improve the quality of patient testing." said Dr. 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 assay to detect anti-dsDNA antibodies 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.
Kimberly Pacella, Director of Clinical Operations at HNL in Allentown, PA chose the HELIOS to address a surge in IFA orders: “In order to absorb all that volume without adding staffing, we need to be able to do things more efficiently. This [HELIOS] will absolutely help with that.” said Pacella.
The HELIOS system and its FDA cleared kits will be displayed at the American Association of Clinical Chemistry meeting and is available in the U.S.
"Our pathology network, SDS Laboratories, has 9 Helios platforms installed in various laboratories throughout Australia. The level of scientific and technical support offered with the systems has been exemplary and unparalleled in my years of experience in diagnostic pathology.”
“On this basis, I have no hesitation in offering my avid recommendation of the products and support of Aesku.”
Lucinda Wallman MB BS PhD FRACP FRCPA, Clinical Immunologist and Immunopathologist, Director of Immunology, Laverty Pathology
Parts of Recommendation Letter, read the full Version here
In addition to the HELIOS, AESKU offers a range of innovative and flexible solutions to meet laboratories' needs in the complex and connected diagnostic testing space.
A powerful software engine and middleware, HERA allows centralized management of any LIS connected analytical instrument in the world.
Tailored to each laboratory's unique testing algorithms, HERA adds efficiency to any workflow and streamlines the daily routine. Read more about HERA