AcetaSTAT Rapid Assay for Acetaminophen Liver Injury

DESCRIPTIONprovided by applicantAlthough acetaminophen is the most common drug for treating pain and feverand also the most common cause of life threatening drug induced liver damagethere are no tests that specifically diagnose a liver injury from an overdoseThe object of this grant is to complete the development of AcetaSTAT ran innovative new method to diagnose an acetaminophen overdoseThe new test was developed by Acetaminophen Toxicity Diagnostics LLCATDin conjunction with the University of Arkansas for Medical SciencesUAMSand the Arkansas Childrenandapos s Hospital Research InstituteACHRIThe advantage of AcetaSTAT ris thatunlike existing testsit is fasteasy and specific to acetaminophen toxicityThis will allow clinicians to quickly and accurately prescribe the correct treatment that will help patients and reduce costsThe proposed work will result in ATDa privately held companyobtaining FDA clearance of AcetaSTAT rso that it can be made available to practicing physiciansThe proposed work willdevelop the final version of AcetaSTAT rusing a monoclonal antibodyproduce AcetaSTAT rin a good manufacturing practicesGMPlaboratoryandtest the clinical performance of AcetaSTAT rin a wide range of patient exposures to acetaminophenATD will continue to work closely with the FDA to ensure that product development and clinical trials are compliant with FDA requirements for AcetaSTAT rto be cleared for commercial sales in the US PUBLIC HEALTH RELEVANCEAcetaminophen Toxicity DiagnosticsLLCATDhas developed a rapidpoint of care blood testAcetaSTATthat will help the diagnoses and treatment of patients that are at risk of dying from liver failure because they have taken too much acetaminophenThis research will fund the final development of AcetaSTAT so that it meets all the criteria to be marketed in the United StatesThis rapidpoint of care test is important because acetaminophen is the most commonly used drug for pain and the most common cause of drug induced liver damageThere are currently no FDA approved tests for the diagnosis of liver toxicity from acetaminophen overdoseThe test will significantly improve the standard of care given to patients by providing information to doctors about the cause of liver injurywhich will guide treatment decisions