Rapid, quantitative and affordable point-of-care diagnostics for oral and oropharyngeal cancer

Project Summary Abstract This proposal seeks to develop and validate a novel technology for detecting malignant cells in biospecimen samples of oral and oropharyngeal cancerThis technology will allow screeningdiagnosisand quantification at higher precision and lower cost than what is currently availableIn the USboth the incidence and societal impact of oropharyngeal cancer are increasingdespite the marked decrease in use of tobacco productsThis is exacerbated by the fact that almost two thirds of patients have lymph node or distant metastases at the time of diagnosisdramatically reducing five year survival ratesIn many developing countriesthe incidence of oropharyngeal cancer is not just higher but also takes a much more dramatic tollOne key reason for the often late diagnosis of oropharyngeal cancers despite their superficial location is that these tumors typically remain asymptoticand early lesions are erroneously considered benignThe current standard of care for detecting oral and oropharyngeal cancer remains histopathologywhich is labor intensive and requires highly trained personnel and a sophisticated infrastructureThusa novel tool to quicklyeffortlesslyand quantitatively determine the presence of these malignancies is urgently neededPARPi FLa fluorescent tracer that has been shown to specifically detect PARPa highly expressed biomarker for malignant growthhas been translated to the clinic at Memorial Sloan Kettering Cancer CenterMSKas an intraoperative imaging agent for oral cancerHoweverSummit Biomedical ImagingLLCSBIbelieves that the non toxic small molecule could be much more useful as an ex vivo stain for suspicious biopsy and brush cytology samplesthusMSK is transferring this technology to SBI for further developmentThe agent is inexpensive andimportantlystable at room temperature for years and stainings can be completed in less thanminuteswhich makes it ideal for an off the shelf diagnostic testTo generate sufficient evidence for the clinical value of PARPi FLboth of our Specific Aims will explore a distinct ex vivo applicationIn Specific AimSBI will develop a one step kitPARP Cytostainand use it in combination with a benchtop cytometer to analyze and detect oral and oropharyngeal cancer cellsfirst preclinicallyand later with human tissuesIn Specific Aimwe will use PARP Instastain to analyze fresh biopsy tissuesUsing a handheldportable fluorescent microscopeanalyses will allow instantaneous diagnosesfirstin rat models andsecondin fresh human oral and oropharyngeal cancer tissuesIf successfulthe proposed novel technologies have the potential to improve and transform the current standard of care for oral and oropharyngeal cancer diagnosiswhich would result in reduced health care costs and improved survival and quality of life for patients around the world PROJECT NARRATIVE In this proposalSummit Biomedical Imaging will partner with Memorial Sloan Kettering Cancer Center to develop a point of care tool for cancer screeningdiagnosisand margin detection in oral and oropharyngeal cancerOur proprietary technology revolves around a small moleculePARPi FLthat selectively targets PARPa biomarker for malignant growthThe core goal of this proposal is to establish inexpensive and quantitative staining kits for brush biopsiesscreeningand freshly excised tissuesmargin detection