Rapid Point-of-Care Diagnostic Test for Chlamydia and Gonorrhea

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DESCRIPTION (provided by applicant): The overall goal of research is to develop a rapid, point-of-care (POC), nucleic acid amplification based diagnostic test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae using our innovative "Lab-in-a-tube" (LiatTM) technology. Chlamydia and gonorrhea are the first and second most frequently reported sexually transmitted diseases in the United States, and around the World. Three quarters of the women and half of the men infected with C. trachomatis are asymptomatic, and thus do not seek medical attention. Although systematic screening of high incidence groups is performed to find asymptomatic patients, a significant percentage of the individuals testing positive for an infection by these organisms do not return to the clinic after their test results. These individuals contribute to the further spread of these diseases in the population. Although rapid tests are available for near patient detection of these infectious agents, these tests lack the sensitivity to detect approximately 40% of cases. Therefore, a more sensitive point-of-care test is needed to reduce the transmission of these sexually transmitted diseases. In our Phase I research, IQuum has demonstrated the feasibility of rapidly detecting C. trachomatis nucleic acids in urine specimens with a sensitivity of detection of 30 elementary bodies (EB) (150 fg) in less than 1 hour, using our Liat system. This system consists of a Liat Analyzer, and disposable Liat Tubes, which can automate all of the processes involved in a nucleic acid amplification test, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification and real-time detection, in one portable device. After the user introduces the biological sample into the tube, the tube remains closed during the test, thus preventing cross-contamination of reagents with samples. In Phase II, we propose to increase the sensitivity of our assays by developing a large volume sample processing device as well as developing assays targeting ribosomal ribonucleic acids. The performance of the IQuum tests will be compared to existing commercial tests by Roche and Gen-Probe and a clinical study plan will be submitted to the Food & Drug Administration (FDA). In Phase III a clinical study will be launched to obtain FDA clearance for sale of the test for human diagnostics. Chlamydia and gonorrhea are the first and second most frequently reported sexually transmitted diseases in the United States, and around the World. A more sensitive point-of-care test for the detection of chlamydia and gonorrhea will increase the percentage of patients receiving treatment for these sexually transmitted diseases and reduce the spread of these organisms in the population.