Revolutionary diagnosis: Alivedx presents a new test for connective tissue diseases!

Revolutionary diagnosis: Alivedx presents a new test for connective tissue diseases!

USA - On April 3, 2025, the Alivedx company officially submitted a 510 (K) advance signing at the US FDA for its innovative Mosaiq Aiplex® Connective Tissue Diseases (CTDPLUS) Microarray. This technology aims to significantly improve the diagnosis of connective tissue diseases by increasing the accuracy and speed and at the same time optimizing the laboratory processes. As early as February 2025, the Mosaiq Aiplus Ctdplus Multiplex-Assay received the IVDR CE certification, which certifies its approval for the European market.

connective tissue diseases include a variety of systemic rheumatic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. Millions of people are affected worldwide, with the diagnosis due to the overlapping symptoms and the common occurrence of these diseases. The Mosaiq Aiplex CTDPLUS test has the ability to detect up to 1,275 disease markers per hour and enables the simultaneous detection of up to 15 auto antibodies recommended in clinical guidelines.

technological innovations in the test procedure

The Mosaiq Aiplex CTDPLUS relies on a combination of several relevant markers in a single test to advance patient care. By using only 10 µl patient sample, the results can be achieved in a single step. All reagents and multiplex microarray magazines are also equipped with RFID tags to save time and minimize potential errors. Alivedx has over 30 years of experience in in-vitro diagnostics, with a special focus on autoimmune diseases and allergies.

connective tissue diseases affect the connection structures in the body, which consist of collagen and elastin. Both proteins are present in different tissues, such as tendons, ligaments, skin and blood vessels. In these diseases, collagen and elastin suffer from inflammation and damage. In medical literature, over 200 different types of connective tissue diseases are described, which can be caused by genetic, environmentally related or unknown causes.

variety of diseases and their treatment

Examples of connective tissue diseases are rheumatoid arthritis, scleroderma, granulomatosis with polyangiitis and systemic lupus erythematodes. These diseases affect different areas of the body and can cause different symptoms. The diagnosis is made by anamnesis, physical examination and specific tests such as imaging and blood tests. Treatment approaches vary depending on the disease and can include vitamin preparations, physiotherapy and medication.

The forecast of connective tissue diseases depends heavily on the type of disease and the selected therapy. Some diseases are mild, others can have serious health consequences. Patients are encouraged to see their doctor in new or deteriorating symptoms in order to take appropriate measures in good time.

The developments of Alivedx are a significant step in improving diagnosis and care for patients with connective tissue diseases, and the industry is looking forward to the results of the FDA examination.

Further information on the topic can be found on Medde .