Opportunity
Cardiovascular diseases (CVD) are the leading cause of death globally, with atherosclerotic vascular disease accounting for most CVD-related mortality. Atherosclerosis is a chronic inflammatory disease characterized by a long asymptomatic period, but its late stages are progressive and irreversible, leading to severe outcomes such as heart attack, stroke, and peripheral vascular disease. Early detection is critical for prevention and treatment, yet it remains a significant challenge. The current gold standard for diagnosis, angiography, is invasive, expensive, and associated with complications like allergic reactions, kidney damage, and stroke, making it unsuitable for regular check-ups. Minimally invasive alternatives, such as patient sample biopsies, offer convenience but rely on traditional biomarkers like cholesterol, LDL, and triglycerides, which lack acceptable diagnostic accuracy, especially in patients with low to moderate cardiovascular risk. Other proposed biomarkers, including inflammatory markers, ox-LDL, and circulating microRNAs, are either non-specific or insensitive to early-stage atherosclerosis. Thus, there is an urgent need for a non-invasive, rapid, and reliable diagnostic method capable of identifying biomarkers for early atherosclerosis detection to enable timely intervention and improve patient outcomes.
Technology
This patent addresses the unmet need by introducing TNFAIP2 (Tumor Necrosis Factor Alpha-Induced Protein 2) as a novel biomarker for atherosclerosis. The innovation is based on the discovery that TNFAIP2, a Yes-associated protein (YAP)-induced secretory protein, is highly expressed in the vascular endothelium surrounding atherosclerotic plaques and in the sera of subjects with early-stage atherosclerosis. The severity of atherosclerosis correlates with serum TNFAIP2 levels, making it a sensitive and specific indicator for early diagnosis, prognosis, and monitoring. The technology encompasses methods for measuring, detecting, or assaying TNFAIP2 levels in biological samples (e.g., serum, plasma, or tissue) from subjects, comparing these levels to controls representative of subjects with or without atherosclerosis. Key components include the use of anti-TNFAIP2 antibodies or binding fragments, particularly those with specific complementarity-determining regions (CDRs), in assays such as enzyme-linked immunosorbent assays (ELISA). The patent also covers kits containing these detection agents for diagnostic applications and methods for treating or preventing atherosclerosis by administering therapies, such as TNFAIP2 inhibitors (e.g., anti-TNFAIP2 antibodies), lifestyle modifications, medications, or procedures, based on TNFAIP2 level assessments.
Advantages
- Provides a non-invasive, rapid, and reliable diagnostic method for early atherosclerosis detection.
- Utilizes TNFAIP2 as a sensitive and specific biomarker correlated with disease severity.
- Enables early intervention, potentially preventing progression to irreversible late-stage atherosclerosis.
- Offers alternatives to invasive angiography, reducing patient risk and healthcare costs.
- Supports personalized treatment strategies by monitoring TNFAIP2 levels to assess therapy efficacy.
- Includes kits with optimized anti-TNFAIP2 antibodies for high accuracy in detection assays.
Applications
- Early diagnosis and prognosis of atherosclerosis in at-risk or symptomatic subjects.
- Monitoring disease progression and severity through serial TNFAIP2 level measurements.
- Evaluating the efficacy of atherosclerosis treatments (e.g., medications, lifestyle changes) by tracking TNFAIP2 levels.
- Screening populations for cardiovascular risk using non-invasive serum tests.
- Developing targeted therapies, such as TNFAIP2 inhibitors, for atherosclerosis treatment.
- Integrating TNFAIP2 detection into routine health check-ups for preventive care.
