Building on the successes of our Phase 1 SBIR project, we propose to refine and productize our sample-to-answer CT/NG NAAT and to validate the analytical and clinical performance of the assay in the intended use setting in Phase 2 of this SBIR project. ?Chlamydia trachomatis (CT) and ?Neisseria gonorrhoeae ?(NG) infections are the number one and two most commonly reported bacterial sexually transmitted infections (STI) respectively, with an estimated 2.86 million new CT cases and 820,000 new NG cases in the US each year, and associated costs exceeding $1 Billion. Both infections are curable with antibiotics, however no CLIA waved, rapid, accurate diagnostic test is available to inform clinical treatment decisions during the patient visit. Untreated infections lead to serious sequelae including pelvic inflammatory disease (PID) and its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic pain. Furthermore, loss to follow-up is a significant problem with STI patients. Therefore, timely diagnosis using accurate diagnostics and early treatment is imperative. Rapid, immunoassay based point-of-care (POC) tests for CT/NG fail to diagnose more than 50% of Chlamydia positive cases. Nucleic Acid Amplification Tests (NAATs) are the current gold standard for diagnosing CT/NG due to their high sensitivity and specificity. As such ??there is great need for an effective POC diagnostic test for CT/NG.
In Aim 1 ?we will integrate assay controls and optimize our multiplex assay for CT/NG.
In Aim 2, we will develop the ?Beta? Novel Dx device that will meet the FDA and CLIA waiver guidance requirements.
In Aim3, ?we will conduct more in-depth analytical studies for sensitivity, inclusivity, exclusivity, cross-reactivity of our optimized sample to answer assay.
In Aim 4, we will place the Novel Dx system in clinical settings and conduct end-user performance and usability evaluations. The outcome of Phase II will provide sufficient data as well as a refined system design to inform a decision regarding multicenter clinical trials and product launch.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are easily cured with antibiotics, however since most cases are asymptomatic, they often go undiagnosed and untreated. Untreated infections lead to serious sequelae including pelvic inflammatory disease (PID) and its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic pain. Timely diagnosis using accurate point-of-care diagnostics and early treatment is necessary. We propose to develop a rapid, automated, multiplex nucleic acid amplification test for CT/NG to enable immediate testing and treatment of infected individuals in a single visit.
