# Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer

> **NIH NIH R44** · GINER, INC. · 2021 · $1,002,148

## Abstract

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.

## Key facts

- **NIH application ID:** 10471039
- **Project number:** 4R44CA240021-02
- **Recipient organization:** GINER, INC.
- **Principal Investigator:** Avni A Argun
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,002,148
- **Award type:** 4N
- **Project period:** 2019-09-17 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10471039

## Citation

> US National Institutes of Health, RePORTER application 10471039, Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer (4R44CA240021-02). Retrieved via AI Analytics 2026-09-14 from https://api.ai-analytics.org/grant/nih/10471039. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*