Detecting Chlamydia (Ct) STIs at the point-of-care (POC) represents a critical unmet medical need. Development of an effective Ct POC diagnostic will result in widespread screening efforts for rapid diagnosis to inform treatment and evaluate treatment efficacy, and for test-of-cure that would not only reduce the acute and chronic morbidity that is directly associated with these infections, but could also provide benefit by reducing potential collateral risks, including HIV-1 infection, cervical cancer, and autoimmune-driven arthritis. Although current diagnostics exist, they remain expensive, are technically challenging, vary in concordance for sensitivity, cannot strain type, take days for results, and ar confined to major clinical or reference laboratories. The overall goal of this Phase I application s to develop a rapid, cheap, user-friendly, sensitive and specific Ct POC diagnostic that can be used in doctor's offices, small to large clinics, teen and STD clinics, emergency rooms, and appropriate resource constrained settings globally.
The Aims of Phase I will be met with the complementary expertise, equipment, and facilities of Dr. Deborah Dean and Diassess. During Phase I, the following will be achieved: 1) a swab processing unit for rapid (~10 min) DNA extraction from clinical samples with minimal operator requirements, 2) diagnostic assay development for rapid (~40 min) and multiplexed Ct detection and strain typing on an inexpensive platform, and 3) sensitivity and specificity determination of the system. Upon completion of these objectives, in Phase II the injection molding manufacturing processes will be developed, leading to highly scalable and low cost devices. A larger sample size, including inhibitory samples will also be analyzed. Primers will be developed against other STIs (GC, HPV, and Trichomoniasis) and integrated into the platform. Additionally, samples from other important clinical sites, including the conjunctiva, pharynx, urine, urogenital ulcer, vagina, and rectum will be tested. Additional funds of ~$3 million, for scale up and clinical trials, will be required to have this product in market by Q3 2017.
The overall goal of this Phase I application is to develop a rapid, inexpensive, user-friendly, sensitive, and specific Chlamydia (Ct) point-of-care (POC) diagnostic that can be used in doctor's offices, small-to-large clinics, teen and STD clinics, emergency rooms, and elsewhere. Detecting Ct STIs at the POC represents a critical unmet medical need with implications in large-scale screening and early detection. A Ct POC would reduce infection rates, inform appropriate treatment, and reduce unnecessary antibiotic use and ultimately, reduce transmission and sequelae.