iKITT Innovative Keratitis Identity Type Test

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PROJECT SUMMARY Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) or due to eye trauma or chemical exposure is a medical problem of significant concern. Annually, keratitis accounts for 930,000 Doctor’s office and outpatient clinic and 58,000 emergency department visits, resulting in $175 million in direct healthcare expenditures and consumption of over 250,000 hours of clinician time. Disease manifestation includes corneal ulcer, edema and/or hypopyon leading to corneal thinning and perforation, elevated intraocular pressure and progression to endophthalmitis. Consequently, clinical outcomes could be severe, including partial or complete loss of vision, necessity for penetrating keratoplasty, corneal grafts, enucleation and evisceration. The current clinical practice involves an eye exam to confirm bacterial, fungal or amoebic keratitis and rule out viral, chemical and trauma induced keratitis. Unfortunately, it is extremely difficult, if not impossible, to distinguish between bacterial, fungal or amoebic keratitis, simply based on the eye exam. Therefore, a corneal scrape sample is collected and sent to the clinical lab for culture based identification of the causative microbe. Meanwhile, the severity of disease progression and the real risk of vision impairment force the clinician to empirically prescribe a cocktail of broad spectrum therapeutics until culture results become available several days later, at which time adjustments to the prescription are made. This current clinical paradigm of visually diagnosing and empirically prescribing therapy encourages the unnecessary use of therapeutics, delays disease resolution, increases the cost of treatment, and most importantly, increases the risk of emergence of therapeutic resistant keratitis causative strains. Lynntech, Inc. in collaboration with the University of Mississippi Medical Center proposes to develop an innovative, rapid, inexpensive and compact test, termed iKITT, to effectively diagnose microbial keratitis and provide causative identity and type information to the clinician at the point-of-care. This information will enable the clinician to shed the current empirical therapeutic prescription paradigm and prescribe a focused monotherapy that has a high likelihood of killing the causative microbe. Thus, iKITT has the potential to sustain major clinical impact by changing the current clinical paradigm to better diagnose and treat microbial keratitis. During this Phase I SBIR effort, our specific aims are to (1) assemble iKITT and demonstrate selective identification of four common keratitis causatives, (2) optimize specificity and sensitivity of iKITT to these targets in the clinically relevant range and (3) preliminarily demonstrate potential clinical utility of iKITT via a non-interventional clinical study. The successful completion of these specific aims should demonstrate ample feasibility of this innovative new microbial keratitis diagnosis approach, and will enable more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of iKITT is likely to sustain high positive clinical impact for the patient populace suffering from microbial keratitis.