Supramolecular PDDA/PEDOT:PSS Biosensor for Early Pancreatic Cancer Detection via CA19-9: Clinical Validation on...

Area of Science:

• Biomedical Engineering
• Nanotechnology
• Oncology

Background:

• Pancreatic cancer has high mortality rates, with early detection being a significant challenge.
• Current diagnostic methods often lack the sensitivity and specificity for early-stage identification.
• Limited therapeutic options are available for advanced pancreatic cancer.

Purpose of the Study:

• To clinically validate a novel multilayered capacitance-based biosensor for early pancreatic cancer detection.
• To assess the sensitivity, selectivity, and performance of the biosensor using clinical samples.
• To evaluate the potential of the biosensor for integration into healthcare systems.

Main Methods:

• Fabrication of a biosensor using self-assembled poly-(diallyldimethylammonium chloride) and (poly-(3,4-ethylenedioxythiophene):polystyrenesulfonate) (PDDA/PEDOT:SS) on gold interdigitated electrodes.
• Surface functionalization with CA19-9 antibodies for biomarker recognition.
• Utilizing electrical impedance spectroscopy, IDMAP, and Bland-Altman analysis for data interpretation and validation.

Main Results:

• The biosensor demonstrated rapid equilibrium (7 min) upon CA19-9 biomarker binding.
• Achieved a limit of detection of 0.01 U/mL and limit of quantification of 0.03 U/mL for CA19-9.
• Showcased high sensitivity and specificity for CA19-9 detection in 24 patient blood samples across different disease stages.

Conclusions:

• The developed biosensor is a promising, innovative tool for the sensitive and selective early detection of pancreatic cancer.
• Clinical validation supports its potential for technology transfer and application within healthcare systems.
• The biosensor's performance in detecting low and moderate CA19-9 concentrations is a key advantage for early diagnosis.