# Liquid Biopsy for Rapid Detection and Real Time Monitoring of FGFR-altered Cancers

> **NIH NIH UH2** · OHIO STATE UNIVERSITY · 2022 · $114,726

## Abstract

Liquid Biopsy for Rapid Detection and Real Time Monitoring of FGFR-altered Cancers
Patients with advanced cancers driven by fibroblast growth factor receptor (FGFR) alterations, including gene
fusions and single nucleotide variants (SNVs), are benefiting from several new FGFR kinase inhibitors.
Erdafitinib and pemigatinib were recently FDA approved for bladder cancer and cholangiocarcinoma,
respectively, and other FGFR inhibitors have received fast-track designation and are being explored in tumor
agnostic basket trials. Patients are experiencing improved overall survival and progression free survival, with
high overall response rates. Unfortunately, virtually all patients eventually develop resistance to these inhibitors,
oftentimes through acquisition of secondary FGFR mutations. FGFR inhibitor development is hindered by the
lack of accurate and comprehensive methods to 1) rapidly detect FGFR alterations in order to qualify patients
for clinical trials, 2) monitor therapeutic response, and 3) characterize emerging drug resistance. The
development of novel testing strategies, such as non-invasive liquid biopsies, can fulfill these unmet needs for
diagnosis, prognosis, and therapy selection. Liquid biopsies evaluate a blood sample, from which cell-free DNA
(cfDNA) shed by the tumor is sequenced to detect genomic alterations. The technical specifications for existing
commercial cfDNA tests show that these assays are not validated for FGFR fusions and have insufficient
sensitivities of ~30% for FGFR fusions. Additionally, commercial tests are too large and costly to repeat
frequently for therapy and disease monitoring. Thus, we propose to develop and validate an FGFR-focused,
accurate, and cost-effective cfDNA sequencing assay (FGFR-Dx) for real-time testing to support rapid detection,
response monitoring, and early detection of resistance. Our team at Ohio State University has six active FGFR
inhibitor clinical trials, a large cohort of FGFR true positives, and a Clinical Laboratory Improvement Amendments
(CLIA)-compliant Cancer Genomics Lab with extensive experience performing clinical-grade tumor sequencing
and bioinformatics analysis for detection and interpretation of gene fusions and single nucleotide variants.
Further, we have paired this cfDNA development with a rapid research autopsy study that will enable the first
systematic evaluation of detection limits for cfDNA by assessing how accurately the heterogeneity observed
across tumor samples from multiple sites is represented in cfDNA. We propose the following Aims to address
the criteria for PAR-18-317: 1) Analytically validate a targeted liquid biopsy assay (FGFR-Dx) to detect fusions
and single nucleotide variants (SNVs) in FGFR1-3; 2) Establish the clinical validity of FGFR-Dx to detect FGFR
fusions and SNVs. In summary, coupling the development of an FGFR-focused liquid biopsy with rapid research
autopsy can broadly impact the field’s understanding and application of cfDNA approaches ...

## Key facts

- **NIH application ID:** 10492663
- **Project number:** 5UH2CA262220-02
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Sameek Roychowdhury
- **Activity code:** UH2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $114,726
- **Award type:** 5
- **Project period:** 2021-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10492663

## Citation

> US National Institutes of Health, RePORTER application 10492663, Liquid Biopsy for Rapid Detection and Real Time Monitoring of FGFR-altered Cancers (5UH2CA262220-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10492663. Licensed CC0.

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