Regulatory approval for the Sniff Magnitude Test

描述(由申请人提供)：当前SBIR第二阶段项目的总体目标是进一步开发嗅觉幅度测试(SMT)并将其商业化，以便它可以更好地用于评估人类的嗅觉损失。SMT是基于当遇到气味刺激时观察到的嗅觉反射样减少。这种反应似乎是快速作用的嗅觉运动回路的一部分，因此不依赖于完成气味识别测试所需的更高阶认知能力。由于其简单，SMT提供了一种快速、可靠和有效的嗅觉功能测试，可用于评估不同年龄、文化背景、语言能力和认知状况的患者。SMT有可能用于与嗅觉丧失有关的患者，并可能对包括阿尔茨海默氏症和帕金森氏病在内的几种神经退行性疾病的诊断有价值。SMT的制造和营销已经安排了战略合作伙伴关系，但在这一努力取得进展之前，必须获得FDA的批准。拟议的项目是临床试验，将涉及测试几个已知患有嗅觉缺陷的患者群体，目的是证明SMT可以在这些群体中安全有效地使用。然后，这些数据将被用作510(K)申请FDA批准SMT的基础。这项申请是根据新修订的NIH政策提出的，该政策规定，当FDA批准是迈向商业化的必要步骤时，SBIR第二阶段延长资金。

DESCRIPTION (provided by applicant): The overarching goal of the current SBIR Phase II project is to further develop and commercialize the Sniff Magnitude Test (SMT) so it can be used to better evaluate olfactory loss in humans. The SMT is based on the reflex-like reduction in sniffing that is observed when an odor stimulus is encountered. This response appears to be part of a fast-acting olfactomotor circuit, and therefore does not rely on higher-order cognitive abilities required to complete odor identification tests. Owing to its simplicity, the SMT provides a rapid, reliable and valid test of olfactory function that can be used for the evaluation of patients of diverse ages, cultural backgrounds, linguistic ability and cognitive status. The SMT has potential for use with patients concerned with smell loss, and may be of value in the diagnosis of several neurodegenerative disorders including Alzheimer's and Parkinson's disease. A strategic partnership has been arranged for the manufacturing and marketing of the SMT but FDA approval must be obtained before this effort can move forward. The proposed projects are clinical trials that would involve testing several patient populations known to suffer from olfactory deficits with the goal of demonstrating that the SMT can be used safely and effectively in these groups. These data would then be used as the foundation for a 510(k) application for FDA approval of the SMT. This application is being made under the newly revised NIH policy that provides for SBIR Phase II extension funding when FDA approval is a necessary step toward commercialization.