Core Insights - Bio-Techne Corporation's Simple Western™ Technology was instrumental in the FDA approval of ZEVASKYN™, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) developed by Abeona Therapeutics [1][5] - ZEVASKYN addresses a significant unmet medical need for RDEB patients, who previously had no durable therapies available [3][8] Company Overview - Bio-Techne Corporation is a global life sciences company that generated approximately $1.2 billion in net sales in fiscal 2024 and employs around 3,100 people worldwide [6] - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product [8] Technology and Methodology - Simple Western was chosen by Abeona for its speed, reproducibility, sensitivity at picogram levels, and minimal sample volume requirements, effectively detecting both trimeric and monomeric forms of Collagen VII [2][4] - The platform provided GMP-compliant data to ensure consistency across ZEVASKYN product lots, overcoming challenges in analytical standardization and complex assay development [4] Clinical Significance - RDEB is a rare genetic skin disorder caused by mutations in the COL7A1 gene, leading to severe symptoms and increased risk of life-threatening complications [3] - The approval of ZEVASKYN marks a significant milestone in the field of cell-based gene therapy, providing a new treatment option for RDEB patients [5]