HEALTHSPAN DIAGNOSTICS, LLC — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant Acute kidney injury AKI is common expensive to treat and is associated with andgt mortality despite advances in supportive care Each year millions of patients undergo cardiovascular surgery medical imaging procedures or cytotoxic chemotherapy placing them at significant risk for developing AKI However while there is an immense clinical need to identify patients at high risk for developing AKI predictive models do not currently exist To make matters worse there are no pharmacologic therapies available for the prevention or treatment of AKI despite a $ billion market opportunity in the US A principal reason for the lack of therapies is the lack of biomarkers capable of identifying patient at high risk for AKI that can be used as an enrichment strategy to power phase clinical trials HealthSpan Dx has identified a biomarker that has potential to predict patients at risk for AKI Our findings in a human clinical trial point to a marker of senescence p INK a as predictor of risk of AKI in patients undergoing cardiovascular procedures Senescent cells lack replicative capacity and therefore cannot contribute to tissue repair and homeostasis In kidney where normally quiescent epithelial cells need to rapidly proliferate to recover from ischemic shock accumulation of senescent cells hinders regeneration and leads to kidney injury A test to measure expression of p INK a mRNA in peripheral blood has been developed in the Sharpless lab and evaluated in various clinical scenarios in andgt human patients IP around this marker was issued in and is the core technology of HealthSpan Dx HealthSpan Dx is developing the assay for commercialization and is actively exploring areas of clinical need In this proposal we will perform proof of concept experiments to determine the utility of p INK a assay for prediction of AKI after cardiac bypass surgery Completion of this Phase I proposal will provide the requisite data to seek Phase II funding for multi center clinical trials to further validate clinical utility of the p INK a diagnostic as a predictor of AKI in patients undergoing cardiovascular procedures Ultimately validation of the p INK a diagnostic as a predictor of AKI would catalyze the clinical development of novel preventative and treatment approaches for AKI PUBLIC HEALTH RELEVANCE Acute kidney injury AKI is common and is associated with andgt mortality despite advances in supportive care Each year millions of patients undergo cardiovascular surgery medical imaging procedures or cytotoxic chemotherapy placing them at significant risk for developing AKI However while there is an immense clinical need to identify patients at high risk for developing AKI predictive models do not currently exist HealthSpan Dx has identified a biomarker that has potential to predict patients at risk for AKI in after undergoing cardiovascular surgery In this proposal we will built on our pilot study and determine the utility of the biomarker for prediction of AKI in a larger cohort of patients undergoing cardiac surgery If successful diagnostic based on measuring expression of this biomarker can assist clinicians with therapeutic decisions by identifying patients at high risk for kidney injury