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Validation of a Muscle-Specific Tissue Image-Analysis Tool for Quantitative Assessment of Dystrophin Staining in Frozen Muscle Biopsies

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Flagship Biosciences’ MuscleMap algorithm that supports therapeutic development for DMD, a fatal neuromuscular disease, has been validated to be as effective as manual pathology. The study was published in the Archives of Pathology & Laboratory Medicine on August 31, 2018.

Duchenne muscular dystrophy (DMD) is a rare, progressive, and fatal neuromuscular disease caused by dystrophin protein loss in muscle. To support investigational treatment approaches, Flagship applied its expertise and proprietary technology in digital tissue image analysis to develop an immunofluorescent scanning and digital image-analysis solution that enables analysis of all muscle fibers within a biopsy section as well as providing data on each individual fiber.

To validate the MuscleMap approach, the study compared high-powered microscopic field total fiber counts and dystrophin-positive fiber counts obtained by trained pathologists to data produced by the MuscleMap algorithm. The authors note that this work is the first to validate immunofluorescent scanning and digital tissue image analysis workflow with the rigor required to support clinical trials.

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