A Single-Molecule Bioelectronic Portable Array for Early Diagnosis of Pancreatic Cancer Precursors

Enrico Genco, Francesco Modena, Lucia Sarcina, Kim Björkström, Celestino Brunetti, Mario Caironi, Mariapia Caputo, Virginia Maria Demartis, Cinzia Di Franco, Giulia Frusconi, Lena Haeberle, Piero Larizza, Maria Teresa Mancini, Ronald Österbacka, William Reeves, Gaetano Scamarcio, Cecilia Scandurra, May Wheeler, Eugenio Cantatore (Corresponding author), Irene Esposito (Corresponding author)Eleonora Macchia (Corresponding author), Fabrizio Torricelli (Corresponding author), Fabrizio Antonio Viola (Corresponding author), Luisa Torsi (Corresponding author)

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Abstract

A cohort of 47 patients is screened for pancreatic cancer precursors with a portable 96-well bioelectronic sensing-array for single-molecule assay in cysts fluid and blood plasma, deployable at point-of-care (POC). Pancreatic cancer precursors are mucinous cysts diagnosed with a sensitivity of at most 80% by state-of-the-art cytopathological molecular analyses (e.g., KRASmut DNA). Adding the simultaneous assay of proteins related to malignant transformation (e.g., MUC1 and CD55) is deemed essential to enhance diagnostic accuracy. The bioelectronic array proposed here, based on single-molecule-with-a-large-transistor (SiMoT) technology, can assay both nucleic acids and proteins at the single-molecule limit-of-identification (LOI) (1% of false-positives and false-negatives). It comprises an enzyme-linked immunosorbent assay (ELISA)-like 8 × 12-array organic-electronics disposable cartridge with an electrolyte-gated organic transistor sensor array, and a reusable reader, integrating a custom Si-IC chip, operating via software installed on a USB-connected smart device. The cartridge is complemented by a 3D-printed sensing gate cover plate. KRASmut, MUC1, and CD55 biomarkers either in plasma or cysts-fluid from 5 to 6 patients at a time, are multiplexed at single-molecule LOI in 1.5 h. The pancreatic cancer precursors are classified via a machine-learning analysis resulting in at least 96% diagnostic-sensitivity and 100% diagnostic-specificity. This preliminary study opens the way to POC liquid-biopsy-based early diagnosis of pancreatic-cancer precursors in plasma.

Original languageEnglish
Article number2304102
Number of pages18
JournalAdvanced Materials
Volume35
Issue number42
DOIs
Publication statusPublished - 19 Oct 2023

Keywords

  • bioelectronics
  • biomarkers
  • early detection
  • pancreatic cancer precursors
  • printed-electronics
  • single molecules
  • single-molecule-with-a-large-transistor
  • Early Detection of Cancer
  • Humans
  • Proto-Oncogene Proteins p21(ras)/genetics
  • Cysts
  • Pancreatic Neoplasms/diagnosis
  • Pancreatic Neoplasms

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