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 AESKU.LAB 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, AESKU.LAB allows centralized management of any LIS connected analytical instrument in the world.
Tailored to each laboratory's unique testing algorithms, AESKU.LAB adds efficiency to any workflow and streamlines the daily routine. Read more about AESKU.LAB
HELIOS automated IFA System - now FDA cleared
AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma
(Wendelsheim / Oakland, California, 29.07.2016) 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 immuno-fluorescence 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.
High flexibility, accepts most tubes
- Tube diameters ranging from 11-13 mm and lengths from 55-100 mm
- Multi-rack sample tube capacity: 106
- The design of the rack and the clamping of the sample tubes increases the overall stability
- Position numbers are clearly printed and easy to read
- The tubes are clamped in the holders to avoid rotation during the reading process of the sample barcodes
- In addition, the use of small control tubes with flat bottoms is also possible
The new HELIOS Multi-Rack is an optional accessory, not included in the HELIOS, sold separately.
Estimated Endpoint Titer Option
Saves Time and Reagents
Easier to find the target dilution - less dilution steps needed. The endpoint titer is defined as the highest dilution in which staining intensity is still detectable. It is an important indicator for the classification of immunofluorescence images. After the first screening run, a titration of positive samples is strongly recommended. The HELIOS EPT Plus offers the possibility to estimate an endpoint titer for wells that were pre-classified as positive in a previous screening mode run. Supported by this endpoint titer estimation, the next dilution steps can easily be selected during the user classification process.
The HELIOS Endpoint Titer is a preinstalled option. Activation only on customer request, activation key sold separately.
Pattern Recognition Add-ons
The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most probable IFA pattern by analyzing captured IFA images.
Rheumatology Pattern Plus Add-on:
This Add-on is able to recognize the following ANA HEp2 IFA patterns:
- Nuclear membrane
- Nuclear Dots
- Speckled (granular)
Vasculitis Pattern Plus Add-on:
This Add-on is able to recognize the following ANCA IFA patterns:
- A-ANCA (X-ANCA)
- Undefined positive
DNA Pattern Plus Add-on: This Add-on is able to descriminate postive/negative nDNA samples.
The HELIOS Pattern Recognition Add-ons are preinstalled options. Activation only on customer request, activation key sold separately
Improved Tissue Processing