Multiplexed microRNA detection platform for early diagnosis and patient management

Información del proyecto

MiRACLE

Identificador del acuerdo de subvención: 101158251

DOI

10.3030/101158251

Proyecto cerrado

Fecha de la firma de la CE 26 Marzo 2024

Fecha de inicio 1 Junio 2024

Fecha de finalización 31 Mayo 2026

Financiado con arreglo a

• European Research Council (ERC)

Coste total

Sin datos

Aportación de la UE

€ 150 000,00

Coordinado por

TEL AVIV UNIVERSITY
Israel

Periodic Reporting for period 1 - MiRACLE (Multiplexed microRNA detection platform for early diagnosis and patient management)

Período documentado: 2024-06-01 hasta 2026-05-31

Resumen del contexto y de los objetivos generales del proyecto

Circulating microRNAs (miRNAs) are small molecules released into the bloodstream that carry information about what is happening inside the body's cells. Scientists have shown that the presence or absence of specific combinations of these molecules in a blood sample can signal the early onset of diseases, including cancer, offering the prospect of simple, minimally invasive testing as an alternative to more complex diagnostic procedures.
Despite this promise, no simple, affordable, and accurate blood test based on this principle has yet been made widely available. The MiRACLE project addressed this gap by developing a novel optical detection platform capable of directly identifying and measuring these molecular signals from a blood sample, without the need for complex laboratory preparation steps. The platform combines a dedicated biochemical detection assay with an optical imaging system and artificial intelligence-based analysis, enabling a panel of disease-relevant molecules to be detected simultaneously in a single measurement, faster, simpler, and at lower cost than currently available approaches.
The overall objective of this Proof of Concept project was to advance this technology originally demonstrated in a research laboratory setting under prior ERC-funded basic research, toward a robust, clinically relevant diagnostic tool, and to test its real-world performance using blood samples from cancer patients. Beyond this initial application, the platform is designed to be broadly applicable to the detection of disease signals across many conditions, with the potential to bring affordable, minimally invasive molecular diagnostics to a much wider patient population.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The project advanced the MiRACLE platform along two complementary tracks: technical development and assay and detection system optimization.
On the technical side, the project developed and refined the full experimental pipeline underlying the platform: probe design for targeted miRNA capture, an optimized surface-based assay for selectively immobilizing single miRNA molecules from complex biological samples, and a dedicated spectral imaging and machine-learning classification pipeline for resolving and identifying individual miRNA species from their unique optical signatures. This pipeline was implemented to be compatible with future automation and scalability.
For clinical demonstration, the project selected diffuse large B-cell lymphoma (DLBCL), the most common aggressive form of non-Hodgkin lymphoma, as a relevant and accessible use case, leveraging an existing institutional ethical approval and an established clinical collaboration for sample access. A cohort of DLBCL patients and matched healthy individuals was recruited, with each patient paired with a healthy control of similar age and sex to support statistically robust, individually matched comparisons. A complete plasma sample handling and miRNA extraction and purification workflow was established and optimized to ensure high-quality input material suitable for sensitive single-molecule detection.
As a benchmarking step ahead of full platform validation, the prepared clinical samples were profiled using an established commercial digital counting platform, enabling simultaneous measurement of several hundred miRNA species across the cohort. Statistical analysis comparing DLBCL and matched control samples identified a panel of candidate circulating miRNAs showing consistent, reproducible differences in abundance between the two groups, several of which showed promising diagnostic separation between patients and healthy individuals. These results, while based on a pilot-scale cohort and therefore exploratory, provide an encouraging, clinically grounded benchmark dataset and candidate biomarker panel against which the MiRACLE optical platform can be directly validated.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

The core result of this project is an optical single-molecule detection platform that measures circulating miRNA biomarkers directly, without amplification, overcoming the bias, cost, and complexity that limit current state-of-the-art profiling technologies. By detecting a panel of miRNA targets simultaneously in a single measurement, the platform offers a combination of sensitivity, speed, and low cost not currently available from existing commercial alternatives.
The project also identified a candidate circulating miRNA biomarker panel for DLBCL, established through a matched case-control design, which provides the clinical reference point for directly benchmarking the MiRACLE platform.
An international patent application has been filed under the Patent Cooperation Treaty, protecting the core innovation and establishing a foundation for commercialization. The broader research program underlying the project's optical detection expertise has also produced related peer-reviewed publications on single-molecule imaging and quantification methods, reflecting the technology platform's broader momentum.
Key next steps for further uptake include direct benchmarking of the MiRACLE platform against the clinical cohort and reference data established here; validation of the candidate miRNA panel in a larger, independent cohort; continued clinical collaboration to support real-world demonstration; and pursuing commercialization pathways building on the filed patent. More broadly, the underlying technology and workflow are not limited to DLBCL and, in principle, are transferable to circulating biomarker detection in other diseases, a significant avenue for future impact.