INANOVATE INC — Department of Health and Human Services SBIR Phase I: 102

Description

Project Summary Although widespread screening by mammography has successfully cut mortality from breast cancer BCa the exquisite sensitivity of the technique results in a startling number of false positives Of approximately million women who receive a positive mammogram each year fewer than will be diagnosed with BCa Cumulatively the economic cost of follow up diagnostics to resolve false positive mammograms is approximately $ billion annually while the social consequences include lost productivity and more than million women exposed to the risks associated with subsequent diagnostics and treatment e g radiation exposure pain and discomfort following a breast biopsy etc Hence a minimally invasive rapid and inexpensive blood test that could be used as a rule out screen for BCa following a positive mammogram potentially offers significant healthcare saving and reduced patient burden Currently available commercial platforms for measuring biomarkers suffer from narrow detection range and or low throughput In turn these limitations constrain the design of diagnostic tests based on biomarkers which restricts their clinical utility To surmount these challenges Inanovate reimagined the approach to biomarker detection The result is a superior biochip platform the Bio ID which can detect biomarkers e g autoantibodies to tumor associated antigens across a log range For comparison the best competitor platform available covers only a log range In addition the Bio ID system is a high throughput format that can be configured to detect any combination of biomarkers making it a powerful tool for clinical and Randamp D tool for designing next generation biomarker based diagnostic assays In this Fast track SBIR Inanovate seeks to advance the Bio ID platform toward commercial launch and to demonstrate its utility by developing a BCa diagnostic that can be used to exclude a breast cancer diagnosis following a positive screening mammogram The test is based on a novel panel of BCa and immune system biomarkers identified by Inanovate and its collaborators at Sanford Research In Phase I the biochip assay will be optimized on the Bio ID system Aim and the system will be benchmarked to previously characterized patient samples and a single sample predictive model for differentiating healthy and cancerous samples will be constructed Aim In Phase II Inanovate will prototype an upgraded Bio ID system for deployment in clinical diagnostic laboratories Aim the predictive model from Phase I will be challenged with a larger dataset Aim and Inanovate will prepare for regulatory approvals and secure commercial partners to advance the platform and diagnostic test to market Aim The successful completion of this work will yield a cost saving BCa diagnostic compared to biopsy and advance a revolutionary new platform that will facilitate biomarker research and enable the next generation of diagnostics to be developed Project Narrative In the United States each year million mammograms require follow up testing to resolve the diagnosis costing $ billion annually and exposing patients to additional health care associated risks Inanovate has developed a first in class biochip platform to measure biomarkers in patient samples As part of this Fast track the proposed Phase I and Phase II studies will enable Inanovate to advance this platform for commercial launch in Randamp D and clinical laboratories and to incorporate a novel panel of breast cancer biomarkers into a rapid inexpensive blood test which can be given to patients after a positive screening mammogram to help resolve the diagnosis