iKITT Innovative Keratitis Identity Type Test - 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.
