PROJECT SUMMARY/ABSTRACT Rapid, Multiplexed 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 DNA (ctDNA). Such assays will be revolutionary for guiding cancer treatment because ctDNA is a very specific cancer biomarker that can be collected non-invasively, thus addressing the challenges of traditional invasive tissue biopsies. Detection of ctDNA is challenging because these biomarkers exist at trace concentrations and are vastly outnumbered by background wild type DNA. Giner, Inc. proposes to develop an electrochemical detection method for rapid, sensitive, and selective detection of single-base mutations in the EGFR gene associated with sensitivity to the tyrosine kinase inhibitor (TKI) class of drugs in non-small cell lung cancer (NSCLC). The developed assay will be adapted for multiplexed ctDNA detection, validated with lung cancer patient plasma samples, and integrated into a prototype microfluidic device, thus achieving a significant milestone toward regulatory evaluation. This technology will help increase access of personalized therapies to NSCLC patients for better treatment outcomes, and offer a compelling competitive advantage over gold standard digital PCR tests in terms of lower cost, minimized sample preparation requirements, increased multiplexed detection, and a much faster sample-to-answer turnaround time.

PROJECT NARRATIVE The goal of this program is to develop a rapid, easy, and low cost electrochemical sensor for non-invasive detection of cancer-specific, gene mutation biomarkers in plasma of lung cancer patients. Detection of these biomarkers will help guide the use of targeted cancer therapies for better outcomes in patients with advanced stage lung cancer, when invasive tissue biopsies are difficult or impossible to obtain.