Rapid, Point-of-Need Diagnostic for Sexually Transmitted Infections

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Project Summary Over 370 million people worldwide are infected with the sexually transmitted infections (STIs) chlamydia, gonorrhea, and trichomoniasis each year. While treatable, delayed treatment can have serious health problems, including infertility, disseminated infection, and pregnancy complications. Since fewer than half of at-risk individuals are screened for these common STIs, it is necessary to destigmatize STI testing and bring rapid point-of-care STI diagnostics to the developed and especially to the developing world, where over 75% of STI cases are thought to occur. Current nucleic acid-based STI tests offer optimal sensitivity and specificity but require laboratory infrastructure (electricity, refrigeration, and trained laboratory technicians) that is largely lacking where these STIs are most prevalent. These tests take days to return a result, which can result in loss of patient to follow-up and treatment. In addition, these tests fail to track the occurrence of antibiotic-resistant gonorrhea. With increases in azithromycin and ciprofloxacin resistance, and more frequent reports of cephalosporin resistance, multidrug- resistant gonorrhea could become a serious threat to global health, necessitating susceptibility testing and antibiotic stewardship. In this SBIR project, GoDx, Inc. proposes to develop a rapid, hand-held, low-cost, and sensitive point-of-care diagnostic to deliver rapid STI test results, which would simplify screening and allow for immediate treatment at the initial visit. To develop a rapid test for chlamydia, gonorrhea, and trichomoniasis, we will focus on innovations to integrate nucleic acid extraction, amplification, and detection to develop and test a prototype device by the end of Phase II. Our easy-to-use sample preparation device would require fewer than three user steps to purify nucleic acids for downstream detection. We will also reach benchmarks for the sensitive and specific amplification of genetic markers in Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis using an isothermal amplification technique followed by lateral flow detection. Our test will also amplify genetic predictors of antibiotic susceptibility to aid in the tracking and treatment of antibiotic resistant gonorrhea. Finally, we will integrate our assays into a test device delivering both STI and AMR test results in 30 minutes, with performance on par with laboratory-based STI tests. Our diagnostic tool will be simple and low-cost, making it ideal for use in the developing world where laboratory infrastructure is lacking, affordable for better screening programs worldwide, and easy enough for eventual in-home testing.