AcetaSTAT Validation and Commercialization

劳拉？詹姆斯 项目总结/摘要 对乙酰氨基酚（APAP）是最常见的药物用于治疗周围的疼痛和发烧 世界它也是危及生命的药物性肝损伤的最常见原因。 不幸的是，医生没有具体的测试可供他们确认诊断的APAP 肝损伤目前，医生依赖于患者的病史和非特异性肝损伤测试， 评估APAP导致的肝损伤患者。Acetaminophen Toxicity Diagnostics，LLC 开发了一种快速的侧流免疫测定法，可以检测APAP肝损伤。我们的测试，被称为 AcetaSTAT是快速，简单和特异性的APAP肝损伤。我们的商业化计划 准备计划提案包括与DCN合作优化AcetaSTAT 诊断。其次，我们将根据当前的良好生产来生产AcetaSTAT 实践（cGMP）。最后，我们将完成体外验证研究，并进行多中心 临床试验，以检查AcetaSTAT的临床性能。这些努力将支持 向食品药品监督管理局提交重新分类申请，以获得销售许可 AcetaSTAT在美国最终，AcetaSTAT将加快和简化APAP的诊断 肝损伤，促进更快速的治疗，挽救生命。 OMB编号0925-0001/0002（修订版03/2020批准至02/28/2023）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