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

Author:

Genco Enrico1,Modena Francesco23,Sarcina Lucia4,Björkström Kim5,Brunetti Celestino6,Caironi Mario2,Caputo Mariapia7,Demartis Virginia Maria8,Di Franco Cinzia9,Frusconi Giulia8,Haeberle Lena10,Larizza Piero6,Mancini Maria Teresa6,Österbacka Ronald5,Reeves William11,Scamarcio Gaetano912,Scandurra Cecilia4,Wheeler May11,Cantatore Eugenio1,Esposito Irene10,Macchia Eleonora57,Torricelli Fabrizio8,Viola Fabrizio Antonio2,Torsi Luisa4ORCID

Affiliation:

1. Department of Electrical Engineering Eindhoven University of Technology Eindhoven 5600 MB The Netherlands

2. Center for Nano Science and Technology Istituto Italiano di Tecnologia Via Rubattino 81 Milan 20134 Italy

3. Dipartimento di Elettronica Informazione e Bioingegneria Politecnico di Milano Piazza Leonardo da Vinci 32 Milan 20133 Italy

4. Dipartimento di Chimica and Centre for Colloid and Surface Science Università degli Studi di Bari Aldo Moro Bari 20125 Italy

5. The Faculty of Science and Engineering Åbo Akademi University Turku 20500 Finland

6. Masmec Biomed – Masmec SpA division Modugno (BA) 70026 Italy

7. Dipartimento di Farmacia‐Scienze del Farmaco Università degli Studi di Bari “Aldo Moro” Bari 70125 Italy

8. Dipartimento Ingegneria dell'Informazione Università degli Studi di Brescia Brescia 25123 Italy

9. CNR IFN Bari 70126 Italy

10. Institute of Pathology Heinrich‐Heine University and University Hospital of Düsseldorf 40225 Duesseldorf Germany

11. FlexEnable Technology Ltd Cambridge CB4 0FX UK

12. Dipartimento Interateneo di Fisica Università degli Studi di Bari Aldo Moro Bari 70125 Italy

Abstract

AbstractA 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.

Funder

H2020 European Research Council

Publisher

Wiley

Subject

Mechanical Engineering,Mechanics of Materials,General Materials Science

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