AcetaSTAT Validation and Commercialization

詹姆士，劳拉·P 项目摘要/摘要 扑热息痛(APAP)是治疗周围疼痛和发烧最常用的药物。 整个世界。它也是威胁生命的药物引起肝损伤的最常见原因。 不幸的是，医生没有专门的检测方法来确认APAP的诊断。 肝脏损伤。目前，医生依赖于患者的病史和非特异性的肝损伤测试，当 评估APAP所致肝损伤的患者。对乙酰氨基酚毒性诊断公司 开发了一种可以检测APAP肝损伤的快速侧向流动免疫分析方法。我们的测试，被称为 AcetaSTAT是一种快速、简便、特异的APAP肝损伤治疗方法。我们的商业化计划 就绪性计划提案包括与DCN合作优化AcetaSTAT 诊断。其次，我们将根据当前的良好制造来生产AcetaSTAT 实践(CGMP)。最后，我们将完成体外验证研究，并进行多部位 临床试验，以检查AcetaSTAT的临床表现。这些努力将支持 向食品和药物管理局提交从头申请以获得销售许可 在美国的AcetaSTAT。最终，AcetaSTAT将加快和简化APAP的诊断 肝脏损伤，促使更快的治疗，并挽救生命。 OMB编号0925-0001/0002(第03/2020版批准至2023年2月28日)第1页

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