SBIR Phase II: Development and Optimization of a New Molecular Test to quantify Latent HIV-1 in Samples from HIV-1 Infected Individuals.

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力将是实现和支持未来开发，批准和临床使用新疗法治愈HIV-1感染。 HIV-1感染可以通过现有的抗逆转录病毒疗法来控制，但由于病毒持续处于静止或潜伏状态而无法治愈。 这种潜伏的HIV-1是治愈感染的障碍。 虽然潜伏的HIV-1可以在所有受感染的个体中发现，但其存在频率非常低。 为了治愈HIV-1感染，必须开发消除潜伏HIV-1的新疗法。 目前缺乏一种灵敏、准确和可扩展的检测方法来检测感染者体内潜伏的HIV-1，这一发展受到阻碍。拟议的项目旨在开发和优化一种灵敏、准确和可扩展的检测方法来检测感染者血液中的潜伏HIV-1。 目前在研究实验室中用于测量潜伏HIV-1的测试要么是非特异性的，要么需要大量血液和许多天才能完成。 该项目的重点是开发一种新的分子测试，专门测量潜伏的HIV-1从最小体积的血液在几个小时内。 具体而言，该项目的重点是定义初始检测性能，并开发用于潜伏HIV-1的新分子检测的稳健性能所需的关键检测控制。 该项目的成功完成将产生一个潜在的HIV-1测试原型，可以推向市场，以支持研究和早期临床试验。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to enable and support the future development, approval, and clinical use of new therapeutics the cure HIV-1 infection. HIV-1 infection can be controlled by available antiretroviral therapy, but cannot be cured due to the persistence of the virus in a quiescent, or latent state. This latent HIV-1 is the barrier to curing infection. While latent HIV-1 can be found in all infected individuals, it is present in very low frequencies. To cure HIV-1 infection, new therapeutics that eliminate latent HIV-1 must be developed. This development is hindered by current lack of a sensitive, accurate, and scalable test to measure latent HIV-1 in infected individuals.The proposed project seeks to develop and optimize a sensitive, accurate, and scalable test to measure latent HIV-1 in the blood of infected individuals. Current tests used in research laboratories to measure latent HIV-1 are either non-specific or require large volumes of blood and many days to complete. This project is focused on developing a new molecular test that specifically measures latent HIV-1 from a minimal volume of blood in hours. Specifically, the project is focused on defining initial test performance and developing critical assay controls needed for robust performance of this new molecular test for latent HIV-1. Successful completion of this project will yield a latent HIV-1 test prototype that can be advanced to market to support research and early-stage clinical trials.