OPP002_LUPUS_DIGITAL_BIOMARKER 📄 Overview Development and validation of novel digital biomarkers derived from continuous wearable sensor data (e.g., specific accelerometer patterns indicating joint inflammation, heart rate variability changes correlating with fatigue, skin thermal imaging for dermatological lesions). These biomarkers aim to provide objective, quantitative measures of lupus disease activity and damage, complementing or even eventually replacing subjective PROs and intermittent clinical scores (like SLEDAI). Initial focus on correlating these digital markers with established clinical and serological markers. Key technologies: 👤 Target users: 👍 Benefits More objective and continuous assessment of disease activity • Earlier detection of subclinical flares or treatment non-response • Accelerated drug development through more sensitive clinical trial endpoints • Personalized adjustment of treatment based on objective data • Reduced diagnostic delay and improved patient stratification Use bullets or new lines. 👎 Challenges Rigorous clinical validation against established gold standards • Distinguishing lupus-specific signals from other comorbidities or environmental factors • Standardization of data collection and biomarker algorithms • Regulatory acceptance and integration into clinical practice guidelines • Cost-effectiveness and accessibility of advanced sensing technologies 📋 Regulatory & Validation Highly likely to be classified as SaMD (diagnostic/monitoring function). Requires extensive clinical validation to demonstrate analytical validity, clinical validity, and clinical utility. Potential for novel predicate device classification.