Progress Report: Advancing Epigenetic Biomarker Detection in Hematological Malignancies

The SANGUINE project continues to make significant strides in the early detection and longitudinal monitoring of hematological malignancies. This European Union-funded initiative aims to transform precision oncology across Europe by developing a state-of-the-art, sequencing-free liquid biopsy platform. By establishing this epigenetic blood test as a standard diagnostic and monitoring tool, the programme seeks to improve clinical outcomes, reduce healthcare costs, and enhance patient quality of life by replacing painful tissue biopsies with a non-invasive alternative.

In this update, we share the latest clinical research developments from our multi-centre trials, detail the core technological innovations driving the platform, and discuss what these advancements mean for hematologists, laboratory directors, and oncology researchers.

Latest Clinical Research Updates from the Field

Recent clinical evaluation phases have generated highly promising data regarding the analytical sensitivity and clinical specificity of the SANGUINE platform. Spanning multiple European clinical hubs and reference networks, these trials encompass a diverse cohort of patients across critical indications, including Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), and various lymphoma subtypes.

By analysing specific molecular biomarkers directly from standard blood draws, the platform achieves high-resolution monitoring without the clinical risks associated with traditional bone marrow aspiration. Key highlights from the latest research phase include:

• Enhanced Performance Metrics: The SANGUINE team reports significant optimisation in diagnostic sensitivity and specificity (consistently exceeding 90% in validated subtypes) compared to legacy episodic diagnostic methods. This directly translates into minimising false positives and false negatives, reducing clinical uncertainty and patient anxiety.

• Minimal Sample Burden: The workflow optimises the use of a small sample of peripheral blood cells and plasma-derived cell-free DNA (cfDNA), making advanced testing highly accessible and minimally invasive.

• Algorithmic Refinement: Ongoing studies are focusing on refining the platform’s predictive algorithms and expanding their use across broader applications, such as Minimal Residual Disease (MRD) tracking and longitudinal surveillance.

Overcoming the Economic and Clinical Bottlenecks of NGS

To understand the impact of the SANGUINE project, it is essential to look at the current diagnostic landscape. For years, healthcare providers have been caught between two suboptimal options: highly invasive bone marrow biopsies—which are accurate but too painful and risky for frequent serial testing—and Next-Generation Sequencing (NGS) liquid biopsies.

While powerful, conventional NGS alternatives are constrained by severe economic barriers. Sequencing tests typically cost between €300 and € 800 per run, require centralised, high-capacity laboratory infrastructure, and take weeks to deliver results. This makes them entirely unsustainable for the frequent testing required to catch patient relapses early.

Continuous multi-centre validation through the SANGUINE project is proving that a decentralised, high-speed, and cost-effective approach can bridge this gap, integrating seamlessly into routine hospital workflows.

Core Innovation: Sequencing-Free Epigenetic Microarray Technology

The true technical differentiator of the SANGUINE platform lies in its transition away from complex sequencing workflows toward a proprietary epigenetic microarray technology.

Instead of searching for genetic mutations, the platform utilises advanced chemical profiling to isolate and map key epigenetic modifications—specifically 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC). By dual-profiling both peripheral blood cells and plasma cfDNA, the system captures subtle molecular signals that characterise disease progression or therapeutic resistance long before standard methods can detect them.

This microfluidic and microarray-based chemistry delivers exceptional operational benefits:

• Rapid Actionable Turnaround: The streamlined laboratory workflow delivers a comprehensive report within 2–3 days of the initial blood draw, accelerating clinical decision-making.

• Standard Infrastructure Integration: The test is engineered to run on standard molecular biology laboratory infrastructure. It does not require capital-intensive NGS systems or hyper-specialised bioinformatics teams, clearing the path for rapid, decentralised deployment in regional hospitals.

Practical Implications for Clinicians and Lab Directors

The operational maturity of the SANGUINE project introduces immediately actionable advantages across the healthcare value chain:

• For Hematologists & Clinicians: The availability of a rapid, reliable, blood-based assay means patients can undergo routine, high-frequency monitoring without biopsy fatigue. This enables highly personalised treatment regimens, allowing for earlier intervention at the first molecular sign of relapse.

• For Laboratory Directors: Sold as a complete kit (including the physical chip, processing reagents, and automated analysis software), the platform allows local laboratories to internalise advanced oncology testing. Because it operates via standard equipment, it maximises laboratory throughput and efficiency.

• For Healthcare Systems: At a targeted price point of €250 per test, the platform significantly undercuts sequencing incumbents, offering payers, health technology assessment (HTA) bodies, and hospital procurement teams an economically viable strategy for serial blood cancer surveillance.

Future Directions and Scaling Across Europe

Looking forward, the SANGUINE project is strategically aligned with the broader goals of Europe’s Beating Cancer Plan. The long-term objective is to achieve widespread regulatory readiness under the European In Vitro Diagnostic Regulation (IVDR) framework and scale the technology globally through a phased rollout.

While early adoption is driven by academic centres and prestige reference sites participating in our clinical trials, the roadmap outlines a transition to a fully decentralised product distribution model. Continued evidence generation, publication of multi-centre health-economic data, and active engagement with national reimbursement frameworks will ensure that this breakthrough technology achieves standard-of-care integration across European healthcare systems.

To stay informed on peer-reviewed data, upcoming technical workshops, and progress from our clinical cohorts, follow the official SANGUINE channels and join the conversation in dedicated professional networks such as the Molecular Diagnostics Lab Managers and Oncology & Hematology Professionals communities on LinkedIn.