? DESCRIPTION (provided by applicant): Although acetaminophen is the most common drug for treating pain and fever, and also the most common cause of life threatening drug-induced liver damage, there are no tests that specifically diagnose a liver-injury from an overdose. The object of this grant is to complete the development of AcetaSTAT(r), an innovative new method to diagnose an acetaminophen overdose. The new test was developed by Acetaminophen Toxicity Diagnostics LLC (ATD) in conjunction with the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Children's Hospital Research Institute (ACHRI). The advantage of AcetaSTAT(r) is that, unlike existing tests, it is fast, easy and specific to acetaminophen toxicity. This will allow clinicians to quickly and accurately prescribe the correct treatment that will help patients and reduce costs. The proposed work will result in ATD, a privately held company, obtaining FDA clearance of AcetaSTAT(r) so that it can be made available to practicing physicians. The proposed work will: 1) develop the final version of AcetaSTAT(r) using a monoclonal antibody, 2) produce AcetaSTAT(r) in a good manufacturing practices (GMP) laboratory, and 3) test the clinical performance of AcetaSTAT(r) in a wide range of patient exposures to acetaminophen. ATD will continue to work closely with the FDA to ensure that product development and clinical trials are compliant with FDA requirements for AcetaSTAT(r) to be cleared for commercial sales in the US.

R42DK079387

2007-07-01

2021-03-31