Program objectives, focus and ambitions

Considering that health care costs are rising excessively, there is an urgent need for better early diagnosis, personalized treatment and counseling. Biomarkers play a crucial role in this area as they contribute to a better diagnosis, help to select patients for personalized medical treatment and provide a sound basis for counseling.

Research has produced lists of ‘biomarker candidates’ for a large number of diseases. Most of these biomarkers are, however, not further investigated in relevant clinical samples and remain at the level of the original discovery.

To accelerate the translation of novel candidate biomarkers into validated clinical tests, the Biomarker-DC will develop highly specific, ultra-sensitive, high-throughput methodologies that will be applied to well-characterized clinical samples from 3 major disease areas: Chronic Obstructive Pulmonary Disease (COPD), Alzheimer’s Disease (AD) and Type II Diabetes (T2D).

To leverage on the expertise of multiple academic research groups and multiple clinical centers, the Biomarker-DC is based on the open innovation network concept. The Biomarker-DC will take promising biomarker candidates from academic research, data mining or industrial partners and validate them in a standardized manner at different clinical centers. The Biomarker-DC follows a matrix organization with technology-driven projects supporting disease-oriented projects as indicated in the scheme. Initially we will pursue six research projects to arrive at validated biomarkers that are ready to mature to molecular diagnostics for the given disease areas, a potential multi-billion Euro market.

Figure 1
Schematic representation of the Biomarker-DC program Each technology development project (1.1–1.3) will support the clinical projects (2.1–2.3) that focus on a given disease area. In that way a matrix is created that allows for thorough testing of the technologies and at the same time for thorough validation of biomarker candidates at multiple centers.

Biomarker research has suffered from a lack of thorough validation leading to a myriad of so-called ‘biomarker candidates’ that hardly translate into useful biomarkers for clinical applications. This ‘biomarker gap’ has considerably increased with the advent of sophisticated ‘omics’ technologies that generate large amounts of data but that are too time-consuming and expensive to do on a large number of samples for robust validation.

In general, two biomarker gaps can be distinguished:
1. from Discovery to Validation
2. from Validation to Applications.

Figure 2
Bridging these gaps in the three designated areas of clinical applications is the remit of the Biomarker-DC. Advancing biomarkers into clinical practice will have a considerable impact on health care quality and cost.

COPD, AD and T2D are each major diseases with millions of patients worldwide. Worldwide, the number of patients with AD is estimated to more than double by 2050. In the Netherlands, 1.5% of the population has dementia and over 5% (€4 billion) of the entire health care budget is spent on care for these patients. In 2050, 2.9% of the Dutch population is expected to suffer from dementia, with a concomitant increase in expenditure for health care. The situation for COPD and T2D is equally disquieting, so overall there is an extreme societal need for earlier diagnosis and better treatment in the selected disease areas.

The Biomarker-DC program expects to deliver a number of proof-of-principle results, related to biomarker technologies and clinical utility of candidate biomarkers in AD, COPD and T2D. We aim to utilize these results for broader application of the biomarker technologies used here, for follow-up biomarker development into diagnostic products, and for accelerated application of the validated biomarkers for clinical care.