Value Proposition:
· Specific biomarker for the detection of major adverse events, including thrombosis, in systemic lupus patients.
· Serum samples are easily accessible for biomarker detection.
· High specificity for thrombotic (clotting) event risk, malignancy and death.
· Leverages common laboratory tests for detection for smooth deployment in the clinic.
· Validation of biomarker tests with the FDA are more streamlined than traditional clinical trials.
Unmet Need:
Systemic lupus erythematosus (SLE, or lupus) affects an estimated 200,000 Americans and disproportionately affects women nine-fold more than men. Lupus is a life-long autoimmune disease in which autoantibodies target human proteins, resulting in tissue damage throughout the body. Lupus patients have a higher risk for developing thrombosis, or unwanted blood clots that can lead to heart attacks or stroke, as well as antiphospholipid syndrome (APS), a common complication of lupus. Current lupus-associated cardiac event monitoring methods are laborious, non-standardized, or fail to predict an event in a large subset of the lupus population. As such, there is a strong unmet clinical need for robust and accurate assays to predict the risk of a thrombotic event in lupus patients.
Technology Description:
Researchers at Johns Hopkins have identified autoantibodies to TFAM, a human mitochondrial protein, as a biomarker for risk of thrombosis and APS in lupus patients. Lupus patients with anti-TFAM antibodies have around three-fold higher risk for thrombotic events. In addition, patients with Anti-TFAM antibodies accrual more disease related damage, are three times more likely to develop malignancies and are 4 times more likely to die during follow-up being cardiovascular disease the most common cause of death among anti-TFAM positive patients. Detection of these antibodies requires a serum sample and may employ common antibody detection assays, such as an ELISA. As these assays are in regular clinic use, detecting anti-TFAM antibodies is accessible for most clinical laboratories with quick testing times. Additionally, this assay can be used with existing SLE serum biomarkers to improve diagnostic and prognostic accuracy.
Stage of Development:
· The assay has undergone analytical and clinical validation in a cohort of 158 SLE patients and 98 healthy controls.
· The assay is ready for commercialization.
Data Availability:
· Data available upon request.
Publication:
1. Gómez-Bañuelos, Eduardo, et al. "Anti-TFAM antibodies link mitochondrial damage with antiphospholipid syndrome and thrombosis in SLE." Annals of the Rheumatic Diseases (2025).
2. Gomez, Eduardo, et al. "Autoantibodies to Transcription Factor a Mitochondria Are Associated with Damage Accrual, Malignancy Risk and Mortality in SLE." ARTHRITIS & RHEUMATOLOGY. Vol. 76. 111 (2024).
