SBIR-STTR Award

iKITT Innovative Keratitis Identity Type Test
Award last edited on: 5/19/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NEI
Total Award Amount
$310,891
Award Phase
2
Solicitation Topic Code
867
Principal Investigator
Anjal C Sharma

Company Information

Lynntech Inc

2501 Earl Rudder Freeway South
College Station, TX 77845
   (979) 764-2200
   requests@lynntech.com
   www.lynntech.com
Location: Multiple
Congr. District: 10
County: Brazos

Phase I

Contract Number: 1R43EY031610-01
Start Date: 9/30/2020    Completed: 6/30/2022
Phase I year
2020
Phase I Amount
$147,526
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.

Public Health Relevance Statement:
PROJECT NARRATIVE The potential long-term impact of this SBIR effort is an effective new paradigm in the diagnosis and treatment of microbial keratitis right at the point-of-care. Our envisioned iKITT has the potential to rapidly inform the clinician of the identity and type of keratitis causative, which in turn, would enable highly pertinent therapeutic prescription with a high likelihood of resolving the disease. iKITT could thus provide significant clinical benefit for microbial keratitis patients worldwide and enable faster healing coupled with lowered costs of treatment.

Project Terms:
Acanthamoeba; Ambulatory Care Facilities; Amoeba genus; Bacteria; base; Bedside Testings; Biological Assay; biomarker identification; Blindness; Buffers; Candida; Chemical Exposure; Chemicals; Clinical; clinical diagnostics; clinical practice; Clinical Research; clinically relevant; Collaborations; Color; commercialization; Consumption; Cornea; Corneal Ulcer; Coupled; Development; Diagnosis; Disease; Disease Progression; Edema; efficacy evaluation; Emergency department visit; Endophthalmitis; Equipment; Eye; fungus; Fusarium; Future; healing; Health Expenditures; Hour; Human; Incubated; Infection; innovation; Keratitis; Keratoplasty; Lateral; Medical; Medical center; Microbe; microbial; Mississippi; Ophthalmic examination and evaluation; Ophthalmologist; Organism; Outcome; Patients; Penetrating Keratoplasty; Perforation; Phase; Physiologic Intraocular Pressure; point of care; Positioning Attribute; Reagent; Reporting; Resistance; resistant strain; Resolution; Risk; Running; Safety; Sampling; Sensitivity and Specificity; Severity of illness; Signal Transduction; Small Business Innovation Research Grant; Specificity; Spottings; Staphylococcus aureus; technology development; Testing; Therapeutic; Therapeutic Uses; Thinness; Time; Trauma; trauma exposure; Treatment Cost; Universities; Viral; Virulence Factors; Virus; Visual impairment

Phase II

Contract Number: 5R43EY031610-02
Start Date: 9/30/2020    Completed: 6/30/2023
Phase II year
2021
Phase II Amount
$163,365
Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) or due to eye traumaor chemical exposure is a medical problem of significant concern. Annually, keratitis accounts for 930,000Doctor’s office and outpatient clinic and 58,000 emergency department visits, resulting in $175 million in directhealthcare expenditures and consumption of over 250,000 hours of clinician time. Disease manifestationincludes corneal ulcer, edema and/or hypopyon leading to corneal thinning and perforation, elevatedintraocular pressure and progression to endophthalmitis. Consequently, clinical outcomes could be severe,including partial or complete loss of vision, necessity for penetrating keratoplasty, corneal grafts, enucleationand evisceration. The current clinical practice involves an eye exam to confirm bacterial, fungal or amoebickeratitis and rule out viral, chemical and trauma induced keratitis. Unfortunately, it is extremely difficult, if notimpossible, 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 ofthe causative microbe. Meanwhile, the severity of disease progression and the real risk of vision impairmentforce the clinician to empirically prescribe a cocktail of broad spectrum therapeutics until culture resultsbecome available several days later, at which time adjustments to the prescription are made. This currentclinical paradigm of visually diagnosing and empirically prescribing therapy encourages the unnecessary use oftherapeutics, delays disease resolution, increases the cost of treatment, and most importantly, increases therisk of emergence of therapeutic resistant keratitis causative strains. Lynntech, Inc. in collaboration with theUniversity of Mississippi Medical Center proposes to develop an innovative, rapid, inexpensive and compacttest, termed iKITT, to effectively diagnose microbial keratitis and provide causative identity and typeinformation to the clinician at the point-of-care. This information will enable the clinician to shed the currentempirical therapeutic prescription paradigm and prescribe a focused monotherapy that has a high likelihood ofkilling the causative microbe. Thus, iKITT has the potential to sustain major clinical impact by changing thecurrent clinical paradigm to better diagnose and treat microbial keratitis. During this Phase I SBIR effort, ourspecific aims are to (1) assemble iKITT and demonstrate selective identification of four common keratitiscausatives, (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. Thesuccessful completion of these specific aims should demonstrate ample feasibility of this innovative newmicrobial keratitis diagnosis approach, and will enable more comprehensive technology development andcommercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of iKITT islikely to sustain high positive clinical impact for the patient populace suffering from microbial keratitis.

Public Health Relevance Statement:
PROJECT NARRATIVE The potential long-term impact of this SBIR effort is an effective new paradigm in the diagnosis and treatment of microbial keratitis right at the point-of-care. Our envisioned iKITT has the potential to rapidly inform the clinician of the identity and type of keratitis causative, which in turn, would enable highly pertinent therapeutic prescription with a high likelihood of resolving the disease. iKITT could thus provide significant clinical benefit for microbial keratitis patients worldwide and enable faster healing coupled with lowered costs of treatment.

Project Terms:
© Copyright 1983-2024  |  Innovation Development Institute, LLC   |  Swampscott, MA  |  All Rights Reserved.