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

Description

ABSTRACT Acute kidney injuryAKIis commonexpensive to treatand associated with andgtmortalityEach yearmillions of patients undergo cardiovascular surgerymedical imagingor cytotoxic chemotherapyall of which place them at significant risk for AKIAroundof cardiac surgery patients develop AKIwith even mild AKI significantly increasing the risk of negative outcomes such as progression to chronic kidney disease andday mortalityAlthough recent research on renal biomarkers has shown promise in diagnosing AKI progressionas yet no tests or models can effectively identify prior to surgery patients at risk for AKI initiationIf patients at risk for developing AKI can be accurately identified before surgerypreoperative and perioperative procedures could be modified to minimize the risk of AKISuch risk minimization is particularly important since there are no pharmacologic therapies available for the effective prevention or treatment of AKIThereforea clinical tool to predict AKI prior to its initiation remains a critical unmet needOnly through early prediction can clinicians make informed decisions to improve the care of patients at risk of AKI and to limit the burden of this catastrophic complication of surgery and critical illnessBy utilizing our novel and robust assay for measuring a patient smolecular ageHealthSpan Dx has developed AKI Saperea multivariate assay that can successfully identify patients at risk for AKI initiation prior to coronary artery bypass graftCABGsurgeryAKI Sapere combines measurement of our innovative marker of molecular age along with a DNA marker of genetic predisposition for cardiovascular diseaseand a baseline measurement of renal functionIn a pilot study ofpatients undergoing CABG proceduresAKI Sapere predicted risk of AKI and was superior to AKI risk models composed of clinical variablessuch as the Cleveland Clinic Thakar scoreor a panel of ten renal biomarkers known to predict AKI progressionIn this Fast Track proposalwe propose to conduct multi center clinical trials to refine the risk score and validate the clinical utility of AKI Sapere to identify patients at risk for AKI prior to CABGCompletion of these aims will demonstrate the clinical utility of AKI Sapere in CABG patients and will allow us to bring this test to marketfirst as a lab developed testLDTand ultimately as an FDA approved devicePrediction of AKI initiation by AKISapere has the potential to dramatically change clinical practice by providing a significantly greater opportunity to interveneto alter the ensuing renal insultto council patients and cliniciansand to ultimately diminish the impact of AKI and the associated morbidity on patients and healthcareFurthermoreuse of AKI Sapere for patient stratification in multiple settings would catalyze the clinical development of novel preventative and treatment strategies for AKIincluding potentially AKI caused by sources other than CABGhigh risk surgeryorgan transplantationradiographic imaging and chemotherapyNARRATIVE Acute kidney injuryAKIis common and is associated with andgtmortality despite advances in supportive careEach year millions of patients undergo cardiovascular surgerymedical imaging proceduresor cytotoxic chemotherapyplacing them at significant risk for developing AKIHoweverwhile there is an immense clinical need to identify patients at high risk for developing AKIpredictive models do not currently existHealthSpan Dx has identified a biomarker that has potential to predict patients at risk for AKI in after undergoing cardiovascular surgeryIn this Fast Track proposalwe will develop and validate the utility of the molecular age biomarker for prediction of AKI in patients undergoing cardiac surgeryWhen completeddiagnostic based on measuring expression of this biomarker can assist clinicians with therapeutic decisions by identifying patients at high risk for kidney injury