Through our Protein Fingerprint technology, we identify fragments of the Extracellular Matrix (ECM) that are released from affected tissues and develop blood-based biomarker assays to quantify disease activity with the aim of precision medicine.
By quantifying tissue remodeling, our biomarkers provide true prognostic and predictive value, as we can select the patients who are most likely to respond to a given treatment and thereby function as surrogate biomarkers for clinical trials. Our biomarker assays not only enable faster drug development but also improve disease outcomes for chronically ill patients by predicting treatment response.
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During the development of pulmonary fibrosis, there are changes in the extracellular matrix. We see the destruction of the basement membrane and the formation of various collagens in the interstitial matrix.
Heart failure with preserved ejection fraction (HFpEF) is a highly complex and heterogeneous syndrome that causes substantial morbidity and mortality, positioning this disease as one of the biggest unmet medical needs today.
The past years have seen great scientific and clinical efforts on elucidating the driving mechanisms, but much remains unknown and successful therapies at still largely absent.
One of the biggest challenges to treating HFpEF is the heterogeneous nature of the syndrome. Risk assessment by conventional biomarkers has not led to any significant therapies, but selection of a more homogenous patient population might be the way forward.
Fibrosis is a hallmark feature of HFpEF pathology, acting as a driver of outcome. Understanding the intricate pathways that lead to fibrogenesis, and how they ultimately impact pathogenesis, is important for understanding how to treat HFpEF. We have developed a biomarker of fibroblast activity, PRO-C6, which independently and with high precision can identify a subset of HFpEF patients with a very elevated risk of adverse outcome.
Watch more videos about Nordic Bioscience’s biomarkers and technology on our YouTube channel!
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If we are to develop precision medicine, we need to identify the right patients. Using Big Data is critical in clinical research, but there is a catch.
Fascination with numbers
The unspoken premise of an optimal approach to patient identification requires measuring proteins so that drug developers can target the right patient with the right treatment. Unfortunately, the case is more complicated than it first appears.
Many biotechnology companies offer protein array services and provide measurement of thousands of proteins. And it is precisely this fascination with numbers that limits the attention to and understanding of the single. Measuring a broad spectrum of proteins is an immature concept at best, and an inadequate one at worst. Hoping to hit the bull’s eye by chance will not benefit the future of patient care.
The right epitope of the right protein
We need insights into pharmacodynamics and response to treatment, and we need to understand disease progression rather than just looking at current status.
To treat the misconception that measuring total proteins is more valuable than measuring a few select biomarkers, we need to refine our approach. Precision medicine needs to know whether the protein or an epitope of the protein, is associated with tissue formation or tissue degradation, protein binding, or signaling.
During tissue remodeling, which is an essential part of life, old or damaged proteins are broken down and replaced with new ones. In this process, specific protein fragments are released into the bloodstream that reflects specific pathobiological and biological processes required for repair and healing, as well as tissue loss and fibrosis. These unique epitopes of extracellular matrix remodeling may provide information about the ongoing pathological processes of damage and repair, thus providing a better opportunity for the development of precision medicine.
Source: Wong et al (2019), Biostatistics
It is a fact that incorporating biomarkers into clinical research increases your chances of success. But that alone is not enough.
Conclusion
The next time you select a panel for your study, consider what you are actually measuring – formation or degradation – and what the biological story of the epitope is. Lastly, if necessary, is the epitope IVD-enabled? This can be done by quantifying the epitope with a technology that is robust, meets CLSI validation guidelines and can be easily made available worldwide.
We have a range of business and laboratory services, and mode-of-action biomarkers that can help you in your drug discovery or research project.
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