Overview
Exagen Inc. is a CAP-accredited and CLIA-certified rheumatology specialty laboratory providing advanced autoimmune disease diagnostics through its AVISE testing platform. The company offers comprehensive biomarker testing for diagnosis, prognosis, and monitoring of systemic lupus erythematosus (SLE), rheumatoid arthritis, and other connective tissue diseases, featuring proprietary Cell-Bound Complement Activation Products (CB-CAPs) technology and over 30 clinically relevant biomarkers.
Frequently asked questions
- What regulatory certifications and accreditations does Exagen hold?
- Exagen is College of American Pathologists (CAP) accredited and CLIA certified. The company has also received conditional approval from the New York State Department of Health for its advanced lupus and rheumatoid arthritis diagnostic tests.
- What are Exagen's key proprietary testing technologies?
- Exagen's flagship technology is Cell-Bound Complement Activation Products (CB-CAPs), introduced in 2012, which provides 22% higher sensitivity for SLE than standard complement measures. The company also offers specialized biomarkers including Anti-C1q for lupus nephritis assessment, Anti-Phosphatidylserine/Prothrombin (PS/PT) for lupus anticoagulant correlation, and Anti-CarP for rheumatoid arthritis erosive disease risk assessment.
- What clinical performance metrics does AVISE Lupus demonstrate?
- AVISE Lupus achieves 80% sensitivity and 86% specificity for SLE diagnosis and offers 48% greater sensitivity than traditional anti-dsDNA testing alone. The test incorporates 10 markers including anti-dsDNA, anti-Smith, and CB-CAPs levels in a tiered assessment algorithm.