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

Description

PROJECT SUMMARY ABSTRACT RapidMultiplexed Biosensor for Non Invasive Detection of Gene Mutations and Personalization of Therapy in Non Small Cell Lung Cancer There is an urgent need for improved blood based liquid biopsies to aid the detection circulating tumor DNActDNASuch assays will be revolutionary for guiding cancer treatment because ctDNA is a very specific cancer biomarker that can be collected non invasivelythus addressing the challenges of traditional invasive tissue biopsiesDetection of ctDNA is challenging because these biomarkers exist at trace concentrations and are vastly outnumbered by background wild type DNAGinerIncproposes to develop an electrochemical detection method for rapidsensitiveand selective detection of single base mutations in the EGFR gene associated with sensitivity to the tyrosine kinase inhibitorTKIclass of drugs in non small cell lung cancerNSCLCThe developed assay will be adapted for multiplexed ctDNA detectionvalidated with lung cancer patient plasma samplesand integrated into a prototype microfluidic devicethus achieving a significant milestone toward regulatory evaluationThis technology will help increase access of personalized therapies to NSCLC patients for better treatment outcomesand offer a compelling competitive advantage over gold standard digital PCR tests in terms of lower costminimized sample preparation requirementsincreased multiplexed detectionand a much faster sample to answer turnaround time PROJECT NARRATIVE The goal of this program is to develop a rapideasyand low cost electrochemical sensor for non invasive detection of cancer specificgene mutation biomarkers in plasma of lung cancer patientsDetection of these biomarkers will help guide the use of targeted cancer therapies for better outcomes in patients with advanced stage lung cancerwhen invasive tissue biopsies are difficult or impossible to obtain