SBIR-STTR Award

Direct to Phase II

Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) cause over 3 million sexually transmittedinfections (STI) annually in the U.S. The estimated global rates are ~131 million and 78 million, respectively.These rates have been increasing 6% to 18% over the last few years. Both are responsible for severemorbidity, including pelvic inflammatory disease, infertility, ectopic pregnancy, chronic pelvic pain, andpreterm birth, with an annual cost of several billion dollars in the U.S. alone. Ct and Ng are treated empirically,relying on antibiotic treatment algorithms because diagnostics for Ct and Ng are not available at the point-of-care (POC). The inability to diagnose and treat at the POC means that many patients are lost to follow up,fueling the transmission of untreated or inappropriately treated STIs. This problem is exacerbated by the highrates of asymptomatic Ct and Ng infections (~10-50% for males & ~70-80% for females) among individualswho are unlikely to seek care. Current diagnostics rely on commercial nucleic acid (NA) amplification tests(NAAT) that are expensive and provide results in a day or days. Most patients are unwilling to wait more than20-30 minutes for a result. Currently, there is no FDA approved CLIA-waived POC test for either Ct or Ng.Our team has been developing instrument-free POC tests for infectious pathogens that can utilize differentsample types with our proprietary lysis buffer and microfluidic amplification assays with easy-to-readcolorimetric results in <30 minutes. No equipment, sample collection or detection kits, or technical expertiseare required. Because Ct rectal infections now outnumber those in the urogenital tract among women, andcontinue to increase among men who have sex with men (MSM) as do Ng infections, there is an urgent needfor a rapid POC test that can utilize these samples for Ct/Ng screening and also for test-of-cure since a singledose of an antibiotic that is used for urogenital infections is inadequate to treat rectal infections. Our aimtherefore is to build on our POC test platform to further develop our lysis buffer and microfluidic assays toprovide a rapid, disposable, sensitive and specific Ct/Ng POC test that can accommodate endocervical,vaginal, urethral, rectal and urine samples. The WHO global action plan to control STDs emphasizes “thedevelopment of affordable point-of-care STI diagnostics.” And the CDC stresses that, “Providers should makeSTD screening a standard part of medical care.” Our Ct/Ng POC diagnostic test will meet this urgent medicalneed by increasing early detection, informing treatment at the POC, and reducing infection rates,transmission, and sequelae with the capability for in-home use and deployment to every type of clinic, healthstation, emergency room and resource constrained setting in the world.

Public Health Relevance Statement:
Project Narrative Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) cause sexually transmitted infections (STIs) with over 200 million cases occurring worldwide each year. Currently there are no CLIA-waived, Point-of-Care (POC) diagnostics for either pathogen yet rates of both are increasing annually (6% to 18%), and rectal Ct and Ng infections among both men who have sex with men (MSM) and women now outnumber urogenital infections, providing additional impetus to include this sample type in a combined Ct/Ng POC diagnostic. We will expand on our recent developments of POC devices for infectious pathogens and develop a rapid (<30 minutes), sensitive and specific, disposable Ct/Ng POC test that will accept clinical endocervical, vaginal, urethral, rectal and urine samples to detect Ct and Ng at the POC to inform treatment decisions and thereby reduce transmission and decrease the global burden and morbidity of these STIs.

Project Terms:
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