AcetaSTAT Validation and Commercialization

James, Laura P Project Summary/Abstract Acetaminophen (APAP) is the most common drug used for the treatment of pain and fever around the world. It is also the most common cause of life threatening drug-induced liver damage. Unfortunately, physicians have no specific test available to them to confirm the diagnosis of APAP liver injury. Currently, physicians rely on patient history and non-specific tests of liver injury when evaluating patients with liver injury due to APAP. Acetaminophen Toxicity Diagnostics, LLC has developed a rapid lateral flow immunoassay that can detect APAP liver injury. Our test, known as AcetaSTAT, is fast, easy and specific to APAP liver injury. Our plans for this commercialization readiness program proposal include optimizing AcetaSTAT in a collaboration with DCN Diagnostics. Secondly, we will produce AcetaSTAT according to current Good Manufacturing Practice (cGMP). Finally, we will complete in vitro validation studies and perform a multi-site clinical trial to examine the clinical performance of AcetaSTAT. These efforts will support the submission of a de novo application to the Food and Drug Administration for clearance for sales of AcetaSTAT in the US. Ultimately, AcetaSTAT will expedite and simplify the diagnosis of APAP liver injury, prompting more rapid treatment, and saving lives. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 1