7375 – Method for Assessing Minimal Residual Disease (MRD) in Acute Myeloid Leukemia (AML) Patients

Background & Unmet Need Acute myeloid leukemia (AML) is a highly lethal disease, accounting for 1.2% of cancer deaths in the U.S. due to significant risk of relapse The presence of minimal residual disease (MRD), the small number of cancer cells after treatment, is a powerful predictor of post-treatment response and relapse in AML patients While frame-shift mutations in nucleophosmin 1 (NPM1) are an established MRD marker, reliable detection of these mutations in a single test remains extremely challenging Patients may have single or a combination of mutation subtypes, many of which are rare and highly patient-specific Unmet Need: Novel method to detect multiple NPM1 mutations in a single, rapid test Technology Overview The Technology: Massively multiplex digital PCR (dPCR) assay with specially designed primers and probes to detect and quantify multiple NPM1 mutation subtypes in a single test Detects >95% of NPM1 mutation subtypes Test remains robust even in instances of high clonal heterogeneity Doesn’t require a priori knowledge of the mutant nucleic acid sequences Reduces the amount of patient sample needed compared to running multiple type-specific assays Technology Applications Regular post-treatment monitoring of the response, remission, and possible relapse in AML patients Technology Advantages Reliable, sensitive, and robust detection of multiple NPM1 mutant subtypes with a single test Requires only a small amount of patient sample Rapid and economical test Publications Mencia-Trinchant et al. “Minimal Residual Disease Monitoring of Acute Myeloid Leukemia by Massively Multiplex Digital PCR in Patients with NPM1 Mutations.” J Mol Diagn. 2017. Patents US Patent Application: US20190144950A1. “Methods of detecting a mutated gene by multiplex digital PCR.” Published May 16, 2019. Brian J. Kelly bjk44@cornell.edu 646-962-7045

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