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A consensus of three physicians confirmed which patients progressed. FDA reviewers report a specificity of 96%, a sensitivity of 73%, a positive predictive value of 97% and a negative predictive value of 71%. The lower confidence bound for sensitivity fell below the 70% goal, which FDA accepted. FDA granted the De Novo request on 11 January 2024. Another 209 eligible patients lacked five years of follow-up and were left out. 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