Multiplex8+: New and innovative RNA diagnostics for the precise and personalized treatment of patients with breast cancer

‍

Project name: Multiplex8+: New and innovative RNA diagnostics for the precise and personalized treatment of patients with breast cancer.

Call: PK 1/2025 - Call for submission of applications for grants for projects of industrial research and experimental development in the field of biotechnology.

Granting authority: Deputy Prime Minister of the Slovak Republic for the Recovery Plan and the Knowledge Economy

Project starting date: 08/2025

Project end date: 12/2027

Project duration: 29 months

Estimated budget: 18 482 658,00€

Abstract

Breast cancer (BCa) remains the most common malignancy in women worldwide and a leading cause of cancer-related mortality, with triple-negative breast cancer (TNBC) representing one of the most aggressive subtypes. In Slovakia, up to 40% of early-stage TNBC patients relapse within five years, generating annual healthcare costs exceeding €3.4 million per 100,000 women. Current diagnostic tools fail to reliably identify patients who would benefit from treatment de-escalation or, conversely, from intensified chemo-immunotherapy (e.g., KN-522 regimen), leading to overtreatment, unnecessary toxicity, and substantial financial burden on the healthcare system.

Our mission is to significantly improve treatment precision in BCa- particularly TNBC- by prospectively validating Multiplex8+ (M8+), an innovative RNA-based diagnostic test designed to guide personalized therapy selection and reduce relapse rates, toxicity, and healthcare costs.

Multiplex8+ integrates proprietary RNA-FISH, laser microdissection, and RNA sequencing into a single comprehensive assay capable of analyzing more than 20,000 biomarkers and predicting response to 33 FDA/EMA-approved therapies. By providing deep molecular profiling at the individual patient level, M8+ enables precise identification of TNBC subgroups, including those unlikely to respond to standard treatment and those achieving up to 85% pathological complete response (pCR) with chemotherapy and KN-522 chemo-immunotherapy. This approach minimizes unnecessary exposure to toxic immunotherapy and has the potential to save approximately €15 million annually in TNBC treatment costs in Slovakia alone.

The 36-month project aims to achieve TRL 8/9 through: completion of retrospective clinical validation in 538 TNBC patients; design and regulatory approval of prospective observational (n=100) and interventional (n=50–100) clinical studies; establishment of a certified centralized diagnostic laboratory in Bratislava(including ISO 15189 accreditation, eQMS, and LIMS implementation); execution of five translational studies; and preparation of two scientific publications. The project will involve leading Slovak oncology centers (NOU Bratislava, VOÚ Košice, Roosevelt Hospital Banská Bystrica, Agel Hospital, Penta Hospitals,University Hospital Trnava) and collaboration with prominent European and international hospitals and biobanks.

Multiplex8+ directly addresses urgent national and European oncology priorities, including Europe’s Beating Cancer Plan, Horizon Europe, and RIS3 SK. By enabling accurate, RNA-driven therapy stratification, M8+ has the potential to transform breast cancer diagnostics, improve survival outcomes, reduce relapse rates, and establish a scalable precision oncology platform adaptable to other solid tumors across Slovakia and the EU.