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

Project SummaryAlthough widespread screening by mammography has successfully cut mortality from breast cancerBCathe exquisite sensitivity of the technique results in a startling number offalse positivesOf approximatelymillion women who receive a positive mammogram each yearfewer thanwill be diagnosed with BCaCumulativelythe economic cost of followup diagnostics to resolve falsepositive mammograms isapproximately $billion annuallywhile the social consequences include lost productivity and more thanmillion women exposed to the risks associated with subsequent diagnostics and treatmente gradiationexposurepain and discomfort following a breast biopsyetcHencea minimally invasiverapidandinexpensive blood test that could be used as aruleoutscreen for BCa following a positive mammogrampotentially offers significant healthcare saving and reduced patient burdenCurrently available commercial platforms for measuring biomarkers suffer from narrow detection rangeand or low throughputIn turnthese limitations constrain the design of diagnostic tests based on biomarkerswhich restricts their clinical utilityTo surmount these challengesInanovate reimagined the approach tobiomarker detectionThe result is a superior biochip platformthe BioIDwhich can detect biomarkerse gautoantibodies to tumorassociated antigensacross alog rangeFor comparisonthe best competitorplatform available covers only alog rangeIn additionthe BioID system is a highthroughput format that canbe configured to detect any combination of biomarkersmaking it a powerful tool for clinical and Randamp D tool fordesigning nextgeneration biomarkerbased diagnostic assaysIn this Fasttrack SBIRInanovate seeks to advance the BioID platform toward commercial launch and todemonstrate its utility by developing a BCa diagnostic that can be used to exclude a breast cancer diagnosisfollowing a positive screening mammogramThe test is based on a novel panel ofBCa and immune systembiomarkers identified by Inanovate and its collaborators at Sanford ResearchIn Phase Ithe biochip assay willbe optimized on the BioID systemAimand the system will be benchmarked to previously characterizedpatient samples and a singlesample predictive model for differentiating healthy and cancerous samples will beconstructedAimIn Phase IIInanovate will prototype an upgraded BioID system for deployment in clinicaldiagnostic laboratoriesAimthe predictive model from Phase I will be challenged with a larger datasetAimand Inanovate will prepare for regulatory approvals and secure commercial partners to advance theplatform and diagnostic test to marketAimThe successful completion of this work will yield a costsavingBCa diagnosticcompared to biopsyand advance a revolutionary new platform that will facilitate biomarkerresearch and enable the next generation of diagnostics to be developed