GINER INC — Department of Health and Human Services SBIR Phase I: NCI

Description

The availability of liquid biopsies such as sampling of blood to measure key disease biomarkers could aid in the detection of blood circulating tumor DNA ctDNA known to confer resistance to cancer therapy For example the T M mutation in the epidermal growth factor EGFR accounts for of acquired resistance to FDA approved EGFR targeted therapies Detection of this mutation is important to evaluate disease relapse and guide the selection of alternative therapies for better treatment outcome Therefore identification of ctDNAs that harbor EGFR specific drug resistant mutations needs to be noninvasive However detection of ctDNAs is challenging because they constitute a small fraction of the total number of normal circulating DNA in blood Current detection methods rely on digital PCR based techniques which are limited because of high cost need for highly trained operators requirement for time consuming sample purification steps slow sample to answer time and limited ability for parallel analysis of a large number of biomarkers To address this need Giner Inc proposes to develop an electrochemical biosensor for multiplexed detection of ctDNA biomarkers associated with acquired resistance to EGFR targeted therapies This sensor will be designed to achieve both selective and sensitive detection of ctDNA in human serum atphysiological relevant concentrations