# Exosomal Thomsen-Friedenreich glycoantigen as a new biomarker for lung cancer screening and early detection

> **NIH NIH R21** · STATE UNIVERSITY OF NEW YORK AT BUFFALO · 2022 · $207,953

## Abstract

PROJECT SUMMARY
Although lung cancer mortality has improved in recent years, it remains the leading cancer killer worldwide. Low
dose computed tomography (CT) scan screening in high-risk patients has shown improved cancer-specific
survival, however, it carries >95% of false-positive rate, a subsequent risk of unnecessary invasive diagnostic
biopsy, and repeated radiation exposure. Liquid biopsy assays have been developed to overcome these
challenges and to enhance the diagnostic accuracy of CT-screened lung nodules. Among many biomarkers,
tumor-derived exosomes (TEXs) have emerged as potent cancer biomarkers. We have discovered a new
exosomal marker, Thomsen-Friedenreich glycoantigen (TF-Ag-α; Galβ1-3GalNAc alpha), as a potential
biomarker for lung cancer early detection. TF-Ag-α is a unique target expressed on the cell surface of about 84%
lung cancers (both nonsmall cell and small cell lung cancer) and other carcinomas (such as breast cancer, colon
cancer, etc), but not on normal tissues. Currently there are no reports about TEX TF-Ag-α and its roles in the
screening and early detection of lung cancer and other cancers. In this project, we select lung cancer as the
disease model and aim to demonstrate the clinical utility of TEX TF-Ag-α in cancer liquid biopsy. To transform
our discovery to clinical applications, we have developed a monoclonal antibody, JAA-F11, with high specificity
to TF-Ag-α and a surface plasmon resonance (SPR)-based liquid biopsy assay to measure the levels of
exosomal TF-Ag-α in blood. We have demonstrated, for the first time, that exosomes carry TF-Ag-α. More
importantly, we successfully detected exosomal TF-Ag-α in as low as 10uL serum samples from both early stage
and late stage nonsmall cell lung cancer (NSCLC) and small cell lung cancer (SCLC) patients, but little signals
from those of normal controls. Based on our promising pilot data, we hypothesize that exosomal TF-Ag-α is a
potent biomarker for lung cancer screening and early detection. In this project, we propose to (1) further develop
the liquid biopsy assay and comprehensively characterize its sensing performances including analytical
sensitivity (limit of detection, limit of quantitation), specificity, linear range, and repeatability; (2) demonstrate the
diagnostic values of exosomal TF-Ag-α in lung cancer screening and early detection using both cell-derived
exosomes and serum samples from well-defined cohorts of patients including lung cancer patients (both NSCLC
and SCLC), individuals with benign pulmonary nodules at high risk of lung cancer and normal controls with no
pulmonary nodules (total n=200). We aim to develop an effective cancer specific biomarker and an accurate
liquid biopsy assay to complement the diagnosis of pulmonary nodules detected during low dose CT screening
and to enhance the accuracy of low dose CT.

## Key facts

- **NIH application ID:** 10511082
- **Project number:** 1R21CA267934-01A1
- **Recipient organization:** STATE UNIVERSITY OF NEW YORK AT BUFFALO
- **Principal Investigator:** GRACE DY
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $207,953
- **Award type:** 1
- **Project period:** 2022-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10511082

## Citation

> US National Institutes of Health, RePORTER application 10511082, Exosomal Thomsen-Friedenreich glycoantigen as a new biomarker for lung cancer screening and early detection (1R21CA267934-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10511082. Licensed CC0.

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