American BioOptics, LLC — Department of Health and Human Services SBIR Phase II: NCI

Description

DESCRIPTIONprovided by applicantThe goal of this small business innovation research grant is to develop and commercialize a highly accurateminimally invasive risk stratification technique for colorectal cancerCRCthat is simple enough to be performed by the primary care provider during an annual physical examAlthough existing guidelines recommend CRC screening for all patients over agertmillion AmericansCRC remains the second leading cause of cancer deathThis is in part due to the limitations in the existing CRC screening techniques including colonoscopy which is considered a `gold standardfor CRC screeningThis is because only a small fraction of eligible population undergoes colonoscopy due to variety of reasons including expensepatient reluctancecomplicationsand insufficient number of endoscopistsFurthermorethe current practice of colonoscopy on the "average risk" population is remarkably inefficient as onlyof the screening population have significant neoplasiaadvanced adenomasHence developing a minimally invasive test to identify patients who do and do not harbor colonic adenomas is of crucial importance to better target patients for colonoscopyThis would enablefor the first timea population wide screening for CRCAn interdisciplinary team of engineersbiologists and clinicians at Northwestern University and Northshore University Health System has developed Low Coherence Enhanced BackscatteringLEBSa novel biophotonic technique that enables sensing the nanoscale tissue morphological correlates of the genetic epigenetic changes in otherwise histopathologically normal mucosaPreliminary animal and human studies demonstrated the potential of LEBS to detect subtle alterations in histologically normalappearing tissue that is due to the presence of cancerous precancerous lesions present in a different part of an organa consequence of the well established concept of field carcinogenesisThis opens a possibility to detect the presence of colonic neoplasia by means of real time LEBS analysis of rectal tissue mucosawhich is readily available upon blind insertion of the minimally invasive LEBS probe in PC or OBGYN settingIndeedin pilot studies onpatientswith bowel preparation for colonoscopyit was noted that the LEBS marker from endoscopically normal rectal mucosal readings mirrored the significance of neoplastic lesions elsewhere in the colonadvanced adenomas rt adenomas rt no neoplasiaThere are several steps that are required prior to the future definitive clinical validation of rectal LEBS analysisIn In yearof the grant periodinstrumentation will be developed necessary to transition the LEBS technology from its initial product configuration intended for use in GI hospital based settingto a configuration allowing for use in PC and OBGYN settingsand a rectal LEBS trial will be conducted ofpatients who will later undergo colonoscopyand a LEBS prediction rule will be subsequently formulatedIn yearof the grant periodthe prediction rule will be verified via an independent cohort ofunprepped patients scheduled for colonoscopywhere the previously developed rectal LEBS prediction rule will be prospectively applied for both advanced adenomas and any adenomasThe successful SBIR research would enable American BioOptics to create a commercially viable diagnostic system that would be critical for future multi center clinical trials and FDA approval