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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力将是促进和支持未来治疗HIV-1感染的新疗法的开发、批准和临床应用。HIV-1感染可以通过现有的抗逆转录病毒治疗得到控制，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，但它存在的频率非常低。为了治愈HIV-1感染，必须开发新的治疗方法来消除潜伏的HIV-1。目前缺乏一种敏感、准确和可扩展的测试来测量感染者体内潜伏的HIV-1，阻碍了这一发展。拟议的项目旨在开发和优化一种敏感、准确和可扩展的测试，以测量感染者血液中的潜伏HIV-1。目前用于研究实验室测量潜伏性HIV-1的测试要么是非特异性的，要么需要大量的血液和许多天才能完成。这个项目的重点是开发一种新的分子测试，可以在几小时内从最小的血液中特异性地测量潜伏的HIV-1。具体来说，该项目的重点是确定初始测试性能，并开发关键的分析控制，以确保这种新的潜伏性HIV-1分子测试的强大性能。该项目的成功完成将产生潜伏性HIV-1测试原型，可将其推向市场，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.