Protagen AG, which specializes in diagnostic medical devices for autoimmune diseases, has launched its first ELISA research use test kit, developed for Systemic Sclerosis (SSc), the ADx®SSc Multilisa®. The diagnostic test was developed by Protagen with the purpose of combining both the identification of novel disease markers and two standard diagnostic markers as a way of helping physicians support their medical decisions regarding autoimmune diseases like scleroderma.
The diagnostic device can currently only be used in investigation as a scientific research-use only (RUO) product, since the company needs to conduct further tests for it to be used by physicians. The three most frequent autoantibodies in SS, anti-topoisomerase I (anti-Scl70), anti-centromere (ACA) and anti-RNA polymerase III (ARA), are present in 60 to 70 percent of the patients, and the ADx®SSc Multilisa® works by identifying these three antibodies, as well as two novel SSc-associated antigens, KDM6B and BICD2.
“Based on our long track record in the discovery and validation of autoantigen biomarkers using the proprietary SeroTag® technology, our development pipeline is built on a strong patent portfolio and designed to support clinical research, targeted therapy, and the continuous delivery of novel diagnostic products,” stated the CEO of Protagen AG, Stefan Müllner.
Systemic sclerosis is a autoimmune disease with major unmet medical needs, and a disease whose patients can benefit from the development of ADx®SSc Multilisa®. Protagen has been dedicated to meeting the demands related to the disease, and according to Müllner, “this underscores our strategy to provide new, improved solutions and product options in autoimmune indications on a continuous basis, enable better therapeutic decision making and improve the diagnostic process for clinicians and, importantly, patients.”