Core Insights - Exagen Inc. has announced the validation and regulatory submission for new biomarkers related to Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis (RA) to enhance the AVISE CTD platform, aiming to improve diagnostic accuracy and reduce the time for autoimmune disease diagnosis [1][2][3] Group 1: Product Enhancements - The new biomarkers include a T Cell Lupus profile with three new T Cell biomarkers (TC4d, TIgG, TIgM) that enhance sensitivity for SLE compared to conventional biomarkers [3][4] - The RA profile will be improved with the addition of four biomarkers (anti-CarP and anti-RA33 biomarkers IgA, IgG, IgM), providing more data for accurate RA diagnosis [4][5] Group 2: Clinical Impact - The enhancements to the AVISE CTD test are expected to provide clinicians with clearer insights into individual patient health, potentially leading to more definitive diagnoses for suspected autoimmune patients [5][6] - The AVISE CTD test has been instrumental in delivering diagnostic clarity for various connective tissue diseases (CTDs) since its launch in 2012, addressing challenges posed by overlapping symptoms and ambiguous disease states [2][5] Group 3: Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions through innovative testing solutions [6][7] - The company's flagship product, AVISE CTD, is designed to assist clinicians in diagnosing complex autoimmune conditions with greater accuracy and timeliness [6][7]
Exagen Inc. Completes Validation and Regulatory Submission for New Lupus and Rheumatoid Arthritis Biomarkers on the AVISE® CTD Platform