Detecting breast cancer with a simple blood test using an accessible and low-cost novel real-time platform

Period of Performance: 08/23/2017 - 01/22/2018


Phase 2 SBIR

Recipient Firm

Inanovate, Inc.
Principal Investigator


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 3.9 million women who receive a positive mammogram each year, fewer than 250,000 will be diagnosed with BCa. Cumulatively, the economic cost of follow- up diagnostics to resolve false- positive mammograms is approximately $4 billion annually, while the social consequences include lost productivity and more than 3 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 7- log range. For comparison;? the best competitor platform available covers only a 4- 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 R&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 31 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 1), 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 2). In Phase II, Inanovate will prototype an upgraded Bio- ID system for deployment in clinical diagnostic laboratories (Aim 1), the predictive model from Phase I will be challenged with a larger dataset (Aim 2), and Inanovate will prepare for regulatory approvals and secure commercial partners to advance the platform and diagnostic test to market (Aim 3). 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.