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Updated: Jul 12, 2025

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Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
Published on: May 9, 2025
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Direct competitive assay for HER2 detection in human plasma using Bloch surface wave-based biosensors.
Tommaso Pileri1, Alberto Sinibaldi2, Agostino Occhicone2
1SAPIENZA Università di Roma, Department of Basic and Applied Sciences for Engineering, Via A. Scarpa, 16, 00161, Roma, Italy.
Analytical Biochemistry
|November 1, 2023
Summary
A novel biosensor detects HER2 (human epidermal growth factor receptor 2) in plasma using Bloch Surface Waves. This rapid, cost-effective method aids breast cancer diagnosis and therapeutic decisions.
Area of Science:
- Biomedical Engineering
- Nanotechnology
- Oncology
Background:
- HER2/neu oncogene overexpression is a prognostic marker in breast cancer.
- Accurate HER2 detection is crucial for cancer diagnosis and treatment decisions.
- Standard detection methods present challenges in speed and cost-effectiveness.
Purpose of the Study:
- To develop a novel biosensing device for HER2 detection.
- To offer a faster and more cost-effective alternative to existing diagnostic techniques.
- To enable real-time monitoring for both diagnosis and therapeutic management.
Main Methods:
- Utilized a biosensing device based on Bloch Surface Waves on a 1D photonic crystal.
- Optimized the 1D photonic crystal for visible spectrum operation.
- Combined label-free and fluorescence detection modes for competitive assay with quantum dot-conjugated antibodies.
- Employed multiplexed detection of HER2-Fc chimera and reference molecules.
Main Results:
- Achieved accurate discrimination between HER2-positive and negative human plasma samples.
- Demonstrated HER2 detection in human plasma in under 20 minutes.
- Validated a cost-effective assay with a rapid turnaround time.
- Showcased the capability for combined label-free and fluorescence detection.
Conclusions:
- The proposed biosensor offers a promising technique for HER2 detection.
- This approach facilitates both diagnosis and therapeutic monitoring of diseases.
- The combined detection strategy enhances accuracy and efficiency.

