Visby Medical, Inc. — Department of Health and Human Services SBIR Phase II: NIAID

Description

Click Diagnostics has developed a new low costdisposablePCR based diagnostic test for multiplexed detection of the sexually transmitted infectionsSTIchlamydiagonorrheaand trichomoniasisThe Centers for Disease ControlCDCestimates that nearlymillion new STIs occur every year and account for almost $billion in health care costsCurrent STI diagnostic testing is primarily done in centralized labs with an average sample to result to patient timeline oftodaysDuring this timeas many asof STI positive patients are lost to care and continue to spread the STIMany others are given inappropriate drugs to avoid the patient leaving without treatmentdespite not having test resultsAlthough point of carePOCnucleic acid amplification based instruments are availablethey can perform only one test at a timelimiting their usefulness in a busy clinicTo ensure patients receive the appropriate antibiotica highly sensitive and specificaffordablePOC diagnostic that provides rapid results is urgently neededThe Click patient sidesingle use disposablepolymerase chain reactionPCRdiagnostic testwith nearaccuracywould allow physicians to ensure no patient with an STI leaves the clinic untreatedClick has developed prototype unitsand successfully validated them using clinical vaginal swab samples from patientsIn this projectwe will refine the device to enable mass productionand optimize the device in preparation for clinical trialskregulatory clearanceand a CLIA waiverThis will require product refinements for manufacturabilityperforming preanalytical and preclinical validationand usability studiesThe goal of Aimis to optimize the pre production unit for manufacturability and clinical testingThis will require using low cost fabrication techniquesminimizing the part count to reduce unit complexityand reducing device size and weightThese modifications enable manufacturing readiness to produce units for preanalytical and preclinical testing in AimPreliminary analytical studies will evaluate the device limit of detection and demonstrate the device results are reproducible and specificClick has partnered with Planned ParenthoodUniversity of Alabamaand Johns Hopkins University for preclinical testing to validate the Click diagnostic testClick will also verify test results against a gold standard PCR instrument by RocheThese tests will assess readiness for clinical testing as required forkregulatory submissionAll tests will be done under strict quality control and document control with Click s advanced quality management systemLastlyin Aimwe will conduct a usability study to ensure that untrained operators can successfully operate the deviceas would be required for a CLIA waiverA CLIA waiver is critical for Click to market its product to physician officesand pharmaciesBased on user feedbackClick will make any necessary modifications to the device or written instructions to meet CLIA waiver requirementsSuccessful completion of this work will yield a production version of a rapidpatient side nucleic acid based diagnostic device ready for clinical testing