Successful Clinical Trials

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.

This can be achieved by targeting the right epitope of the right protein.

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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    Tumor Fibrosis Biomarkers

    Guiding Immune Checkpoint Inhibitor Therapy

    Emerging evidence indicates that one central common denominator of resistance to immune checkpoint inhibitors may be fibrotic activity characterized by collagen production by cancer-associated fibroblasts (CAFs).

    Consequent to increased fibroblast activity, specific collagen fragments are released into the circulation and can be used as non-invasive biomarkers assessed in a liquid biopsy such as serum or plasma. PRO-C3 quantifies the formation of type III collagen and can therefore be used as a non-invasive biomarker of tumor fibrosis.

    Watch more videos about Nordic Bioscience’s biomarkers and technology on our YouTube channel!

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      Early Detection of Neuron Loss in Alzheimer’s

      Tau-C Biomarker

      The Tau-C biomarker assay uses an antibody that specifically detects a fragment of tau produced by caspase-3. This assay is capable of detecting neuron loss already in the early stages of Alzheimer’s disease before the onset of symptoms.

      After establishing the assay, we performed measurements in blood samples from individuals with brain injury, as brain injury is known to result in loss of neurons and release of fragments into the bloodstream.

      Watch more videos about our biomarkers and the Protein Fingerprint on our YouTube channel!

      Watch more videos about our biomarkers and the Protein Fingerprint on our YouTube channel!

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        Extracellular Matrix Animation

        Quantifying Tissue Remodeling Through the Protein Fingerprint

        The human body is formed from a single cell that divides into trillions of cells that make up the unique organs of our bodies. All cells in the human body carry the same genetic material.

        The only way they know how to interact, behave, and form the organs is because of the context that surrounds them. This context is called the extracellular matrix.

        Watch more videos about the extracellular matrix and the Protein Fingerprint on our YouTube channel!

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          Why Collagens Matter – The Importance of the Extracellular Matrix (ECM)

          The Importance of the Extracellular Matrix (ECM)

          Collagens are the most important structural component of all tissues, just like the beams of the Eiffel Tower. We need these collagens and beams in optimal quality and strength, otherwise disasters will occur.

          Every organ in the body needs constant repair to stay healthy. As a result, collagens are remodeled, which supports these tissues. If we could understand these signals of regeneration, how tissues are remodeled, we could cure most diseases, renew the organs of the body, and reverse chronic diseases. 

          Watch more videos about collagens and the ECM on our YouTube channel!

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