Commercialization of low cost, disposable, point-of-care molecular diagnostic device for sexually transmitted infections

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Click Diagnostics has developed a new low-cost, disposable, PCR-based diagnostic test for multiplexed detection of the sexually transmitted infections (STI) chlamydia, gonorrhea, and trichomoniasis. The Centers for Disease Control (CDC) estimates that nearly 20 million new STIs occur every year and account for almost $16 billion in health care costs. Current STI diagnostic testing is primarily done in centralized labs with an average sample-to-result-to-patient timeline of 3 to 5 days. During this time, as many as 30% of STI-positive patients are lost to care and continue to spread the STI. Many others are given inappropriate drugs to avoid the patient leaving without treatment, despite not having test results. Although point-of-care (POC) nucleic acid amplification based instruments are available, they can perform only one test at a time, limiting their usefulness in a busy clinic. To ensure patients receive the appropriate antibiotic, a highly sensitive and specific, affordable, POC diagnostic that provides rapid results is urgently needed. The Click patient-side, single-use disposable, polymerase chain reaction (PCR) diagnostic test, with near 100% accuracy, would allow physicians to ensure no patient with an STI leaves the clinic untreated. Click has developed prototype units, and successfully validated them using clinical vaginal swab samples from patients. In this project, we will refine the device to enable mass production, and optimize the device in preparation for clinical trials, 510(k) regulatory clearance, and a CLIA waiver. This will require product refinements for manufacturability, performing preanalytical and preclinical validation, and usability studies. The goal of Aim 1 is to optimize the pre-production unit for manufacturability and clinical testing. This will require using low cost fabrication techniques, minimizing the part count to reduce unit complexity, and reducing device size and weight. These modifications enable manufacturing readiness to produce units for preanalytical and preclinical testing in Aim 2. Preliminary analytical studies will evaluate the device limit of detection and demonstrate the device results are reproducible and specific. Click has partnered with Planned Parenthood, University of Alabama, and Johns Hopkins University for preclinical testing to validate the Click diagnostic test. Click will also verify test results against a gold standard PCR instrument by Roche. These tests will assess readiness for clinical testing as required for 510(k) regulatory submission. All tests will be done under strict quality control and document control with Click’s advanced quality management system. Lastly, in Aim 3 we will conduct a usability study to ensure that untrained operators can successfully operate the device, as would be required for a CLIA waiver. A CLIA waiver is critical for Click to market its product to physician offices, and pharmacies. Based on user feedback, Click will make any necessary modifications to the device or written instructions to meet CLIA waiver requirements. Successful completion of this work will yield a production version of a rapid, patient-side nucleic acid-based diagnostic device ready for clinical testing.