Category: Scientific Insights

Nordic Bioscience Q1 2024 Publications Digest

Posted on by Claire Hornung

Did we cover your area of interest?

We have highlighted some our publications that we and our collaborators worked on in the first quarter of 2024—in no particular order. We invite you to browse and read according to your interests!

Oncology

Fibroblast activation protein (FAP) is almost exclusively expressed in pathological conditions including multiple types of fibrosis and cancers, making it an optimal target for treatment.

Treatment strategies utilizing the unique proteolytic activity of FAP are emerging, thus emphasizing the importance of biomarkers to directly assess FAP activity.

CWe developed a non-invasive quantification tool for FAP-activity, specifically generated through FAP-mediated cleavage (C3F) for selection and monitoring of patients in FAP-related clinical trials.

Read the article here

Neurology

Novel treatments for Alzheimer’s Disease are intensely sought; however, there is a dire lack of good biomarkers identifying the population with active disease progression, i.e. those in need of treatment.

We measured our Tau-A and Tau-C assays in a clinical cohort of patients with well-characterized Alzheimer’s Disease, and we observed that Tau-A was related to the CSF-levels of Aβ1-42, while Tau-C levels were indicative of fast progression, and as such identified a population of great interest.

Read the article here

Cardiology

We explored the involvement of the extracellular matrix (ECM) in various cardiomyopathies and its impact on myocardial stiffness and fibrosis. We also discussed the potential of ECM fragments for early diagnosis, prognosis, and risk stratification.

Cardiomyopathies constitute a diverse group of disorders characterized by fibrosis, ultimately leading to heart failure. Utilizing ECM biomarkers could enhance diagnosis and guide personalized therapies targeting fibrosis.

Read the article here

Nephrology

We investigated whether a degradation fragment of collagen type III (C3M) correlated with markers of inflammation and endothelial dysfunction and whether C3M was a risk marker for progression of chronic kidney disease (CKD)in persons with type 2 diabetes and microalbuminuria.

Higher serum C3M is a risk marker for CKD progression and correlates with markers of inflammation in persons with type 2 diabetes. Moreover, a doubling of serum C3M was associated with CKD progression (with mortality as competing risk) after adjustment for conventional risk factors.

Read the article here

Rheumatology

In our first rheumatology publication, we investigated M6495, a new drug targeting ADAMTS-5, in healthy volunteers and osteoarthritis patients.

M6495 was safe and well-tolerated at doses up to 300mg. It significantly reduced a key biomarker of cartilage breakdown, suggesting potential to slow disease progression.

Read the article here

In the second study explored a new biomarker for response to Tocilizumab, a treatment for rheumatoid arthritis. Measuring type VI collagen degradation (C6M) identified patients who benefited more from the drug.

This approach has potential to personalize treatment and improve outcomes for RA patients.

Read here

In our third rheumatology publication, highlighted the need for better ways to classify osteoarthritis (OA). Current treatments only manage symptoms, and a deeper understanding of the disease is crucial.

We propose using a panel of biochemical markers to define different OA subtypes (endotypes).

Read here

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    2021 Annual Review: Publication Record in Quality and Quantity

    Posted on by Claire Hornung

    We are changing people’s lives and making an impact!

    “I hope this year will be as productive as last year! Congratulations to Team Nordic,” said Morten Karsdal, CEO of Nordic Bioscience, as we close out 2021 and head into 2022. “Thank you for your commitment and support to our mission: to change people’s lives through precision medicine and serological quantification of the extracellular matrix (ECM), enabled by high-precision instrumentation,” Morten Karsdal emphasized.


    Nordic Bioscience has published a total of 59 publications in 2021, exclusively in peer-reviewed journals, with an average impact factor of 6.62, which shows the impact Nordic Bioscience scientists are leaving in the field. This means that quantity and quality go hand in hand, as an impact factor above 5 is a very good distinction. Even more, many of these 59 publications have an impact factor above 10 or even 20.


    Nordic Bioscience’s research group is highly regarded in its field and a leader in extracellular matrix (ECM) science and quantification, proving that the company’s efforts are having an impact.


    “When we visited customers in December during our normal pharma tour,” says Morten Karsdal, “I often heard how impressed our customers were with the interaction of our senior scientists and directors and the seamless coordination of the lab. “It is clear that we are all making a difference by trying to do things a little bit better every day,” the CEO added.


    These successes are the culmination of a year-long team effort. The publications are based on data, and all data start with an idea for a biomarker. Assay development, assay production, assay validation, assay measurements, biobank samples, legal contracts, quality control, data reporting, and so on: all these pieces of the puzzle are required to produce publications that demonstrate value to patients and science.

    Finally, the 3rd edition of Nordic Bioscience’s collagen book will be published in 2022, after the 2nd edition was downloaded 9000 times.

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      Best of 2022 Publication Digest

      Posted on by Claire Hornung

      Did we cover your area of interest?

      Nordic Bioscience digest of the Best of 2022 publication series

      In 2022, our scientific teams have once again worked incredibly hard to advance our technologies to better benefit patients in need. With more than 60 publications, we have published an average of more than 5 articles per month this year.

      We have put together the best of 2022 for you from our various focal points—in no particular order. We invite you to browse and read according to your interests!

      Respiratory

      Novel treatments for idiopathic pulmonary fibrosis (IPF) are needed to combat this devastating disease.

      To investigate the antifibrotic effect of novel compounds and increase the chances of success in clinical trials, blood-based biomarkers may already be introduced at early stages of development.

      Read article

      Gastroenterology

      Conventional serum calprotectin biomarkers are often not as clinically useful as the fecal versions because the short half-life of calprotectin in blood reduces the window in which the current serum calprotectin ELISA assay can detect calprotectin dimer protein.

      CPa9-HNE ELISA has emerged as a novel serum calprotectin biomarker with significant clinical potential as a biomarker for patients with IBD to monitor disease activity and neutrophil activity.

      Read article


      Hepatology

      Monitoring changes in the extracellular matrix during liver fibrosis is of great interest. Biomarkers to assess fibrogenesis already exist, but biomarkers of fibrosis resolution have not been validated.

      These biomarkers would be equally valuable for understanding disease progression or the mechanism of a particular intervention, and for understanding the potential induction of hepatic fibrosis resolution.

      Read article


      Dermatology

      Identification of biomarkers associated with psoriatic arthritis (PsA) disease and their potential as predictors of response to treatment are unmet needs in PsA.

      The aim of the study was to investigate the association of serum levels of tissue turnover biomarkers with PsA disease phenotypes and response to Guselkumab treatment.

      Read article


      Rheumatology

      All agree that osteoarthritis (OA) is a heterogeneous disease – drugs in development fail because there is no approved way to segregate patients to give them targeted treatment.

      Endotyping is necessary to understand the pathogenesis that drives the disease in individual patients. In the APPROACH consortium, we have measured biochemical markers that reflect the pathogenesis of different tissue compartments affected by the disease.

      Read article


      Cardiology

      A persistent problem remains unresolved in heart failure with preserved ejection fraction – targeted treatment for highly heterogeneous patients.

      This heterogeneity can be the cause of the lack of response to treatment in clinical trials, making it difficult for trials to succeed. The field needs better actionable biomarkers capable of finding the patients most in need of treatment – and that starts with PRO-C6.

      Read article


      Oncology

      Pancreatic cancer is an extremely lethal and fibrotic cancer disease. Novel tools such as biomarkers and preclinical models that can improve understanding of tumor fibrosis biology, drug development, and disease progression are urgently needed.

      In this publication, we established a pseudo-3D in vitro pancreatic CAF model in combination with clinical collagen biomarkers (PRO-C3 and PRO-C6) as a translational screening tool for antifibrotic drugs.

      Read article

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        Best of 2023 Publications Digest

        Posted on by Claire Hornung

        Did we cover your area of interest?

        Nordic Bioscience digest of the Best of 2023 publication series

        2023 – a year of a series of scientific successes for Nordic! Our scientific teams have worked incredibly hard to advance our technologies to better benefit patients in need. With close to 60 publications, we averaged at least 5 articles per month – just like last year. We have put together the best of 2023 for you from our various focal points—in no particular order. We invite you to browse and read according to your interests!

        Respiratory

        New biomarkers are crucial for identifying fast-progressing idiopathic pulmonary fibrosis (IPF) patients. We evaluated the serological value of two vimentin neo-epitopes, VIM and VICM, in IPF.

        While both originate from the same fragment, VIM measures vimentin degradation, and VICM reflects macrophage activity through citrullination. Notably, unlike VIM, VICM demonstrated significant prognostic value, effectively distinguishing fast-progressing from non-progressing IPF patients at diagnosis.

        Read the article

        Clinical lab

        This paper highlights the potential of biomarkers to expedite drug development, emphasizing their role as early indicators for improved clinical response, enhanced patient safety, and personalized medicine.

        We explore lessons learned by the EU IMI2-funded LITMUS consortium in their interactions with regulatory agencies, underscoring the significance of sharing such knowledge with the scientific community to increase the likelihood of qualifying relevant biomarkers and facilitating common understanding and support in decision-making frameworks.

        Read the article

        Hepatology

        This publication introduces a novel approach for nonalcoholic fatty liver disease (NAFLD) by identifying a “high-risk, high-fibrogenesis” patient endotype using collagen formation biomarkers.

        Characterized by elevated fibroblast activity, this endotype responds well to a very low-calorie diet, showing a significant reduction in collagen fibrogenesis with weight loss. Quantifying fibrogenesis biomarkers allows predicting treatment response at baseline.

        Read the article

        Dermatology

        First publication highlight:

        Skin tissue remodeling is vital for maintaining homeostasis but can be disrupted in conditions like atopic dermatitis, psoriasis, and hidradenitis suppurativa. Type VI collagen is crucial for ECM assembly in human dermal fibroblasts.

        Specific fragments of type VI collagen can serve as blood biomarkers for dermatological conditions. Quantifying the levels of type VI collagen inpatients with dermatological disorders could prove to be a valuable tool for both patient identification and drug development.

        Read the article

        Second publication highlight:

        The pathogenesis of axial spondyloarthritis (axSpA) involves tumor necrosis factor (TNF)-α-induced joint inflammation. However, choosing optimal treatments for axSpA in a timely and non-invasive manner remains a challenge in clinical practice.

        Blood-based biomarkers present a cost-effective and accessible solution. Exploring ECM biomarkers as potential pharmaco-dynamic markers may aid in predicting and monitoring TNF-α inhibitor treatment responses in axSpA patients. This research also sheds light on the development of new effective therapeutic strategies.

        Read the article

        Cardiology

        Recent evidence suggests Empagliflozin may have anti-fibrotic effects, notably reducing type I and III collagen (PINP and PRO-C3). Lower levels of type VI collagen (PRO-C6) are associated with milder heart failure outcomes but increased risks of hospitalization, mortality, and renal complications.

        Accurate assessment of extracellular matrix remodeling is crucial for precise heart failure patient endotype identification. Other studies reveal a 12.4% and 9.2% increase in cardiovascular or all-cause mortality risk per 1 ng/ml rise in PRO-C6.

        Read the article

        Oncology

        Our study explores tumor collagen quantity and quality, emphasizing cancer-associated fibroblasts (CAFs) and their role in tumor fibrosis. We connect serological collagen biomarkers to specific CAF subtypes within the tumor microenvironment, building on our FDA-supported letter of support for the initial serological biomarker for tumor fibrosis.

        The unique collagen profiles linked to CAF subtypes present potential avenues for discovering new cancer biomarkers and therapeutic targets.

        Read the article

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          Quantification of active TGFβ in serum predicts treatment response in solid tumors

          Posted on by Daniel Gabor

          TGFβ signaling: a game changer in personalized cancer treatments?

          Treatment outcomes are deeply influenced by the tumor microenvironment (TME) where TGFβ (Transforming Growth Factor Beta) has emerged as a critical factor that can dictate the success—or failure—of therapeutic strategies.

          As shown below (Figure 1.) in an example from renal cell carcinoma (RCC), high TGFβ activity contributes to poor responses to tyrosine kinase inhibitors (TKIs) as compared immune checkpoint inhibitors. TGFβ activity was measured by the TGFβ-LAP biomarker in pre-treatment serum.

          Conventional TGFβ assays are affected by platelets releasing TGFβ during clotting (drastically affecting the measurements in serum). In contrast, the TGFβ-LAP biomarker quantifies a cleaved latent activating protein (LAP) fragment which is independent of platelet TGFβ release providing a novel tool to indirectly measure TGFβ in serum.

          Figure 1. TGFβ (Transforming Growth Factor Beta) has emerged as a critical factor that can indicate success rate

          Why does this happen?

          TKIs, such as Sunitinib, are primarily targeting angiogenesis and signaling pathways critical for tumor growth. However, elevated TGFβ promotes an immunosuppressive and fibrotic TME, counteracting these therapies by enhancing tumor resilience and protecting vasculature from the intended effects of TKIs. On the other hand, anti-PD-1/anti-CTLA-4 immuno-oncology (IO) therapies such as Nivolumab and Ipilimumab, which aim to re-activate T-cell responses, may be relatively more effective even in a TGFβ-rich environment.  

          Personalizing treatment (TKI vs. IO) with biomarker-driven approaches

          Understanding TGFβ activity could be a game-changer in personalizing cancer treatments. Biomarkers that measure TGFβ levels or its downstream effects might help clinicians choose between TKIs or immunotherapy – or even better, design combination regimens. This underscores the importance of a biomarker-driven approach to cancer treatments. As we continue to unravel these mechanisms, the goal remains clear: to turn the TME from a shield into a target. 

          Our approach is designed to be implemented into clinical trials and research programs on TKI vs. IO, and to help explore the intersection of TGFβ biology and therapeutic resistance.

          Read our related publication on PubMed

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            α-synuclein—a critical protein in Parkinson’s disease

            Posted on by Claire Hornung

            Understanding Parkinson’s Disease Progression Through Protein Biomarkers

            Parkinson’s Disease (PD) is a complex neurodegenerative disorder, primarily affecting the brain’s control over movement, thought, memory, and emotion. Early symptoms often manifest as tremors due to impaired motor skills. Underlying these visible symptoms is a cascade of molecular changes, beginning with alterations in specific proteins—one of which, α-synuclein, plays a critical role in PD pathology. In Figure 1, we have illustrated how α-Synuclein aggregates, which impairs the motor neuron.

            Figure 1. Patients diagnosed with Parkinson’s Disease is affected by A) α-Synuclein aggregates affecting the motor neurons, B) Neuron loss and degeneration, and C) Blood-Brain-Barrier (BBB) leakage and neuroinflammation, by activated microglia, reactive astrocytes and extracellular matrix destruction.

            In a healthy brain, α-synuclein supports neuronal communication. However, in Parkinson’s, this protein undergoes abnormal processing, driven partly by the enzyme Calpain-1, which cleaves α-synuclein into smaller, altered fragments. This early cleavage disrupts cellular function and promotes the formation of toxic aggregates, which accumulate, kill neurons, and drive disease progression. Intriguingly, these fragmented proteins can cross the blood-brain barrier and enter the bloodstream, providing a potential “window into the brain” for tracking disease activity from a simple blood sample.

            At Nordic Bioscience, we have developed an innovative approach to harness this biomarker potential. Using our ProteinFingerPrint Biomarker Technology™, we can detect Calpain-1-cleaved α-synuclein fragments in blood serum with high precision. Our specific assay, α-SYN-C, captures the unique “fragment fingerprint” of PD by quantifying these cleaved fragments, which are significantly elevated in the blood of PD patients compared to healthy individuals, as illustrated in Figure 2.

            Figure 2. Patients with Parkinson’s Disease has significant higher levels of α-SYN-C in serum, compared to healthy donors. The α-SYN-C biomarker detects levels of α-Synuclein cleaved by Calpain-1 in serum. The assay is technically validated for measurements in human blood samples.

            This biomarker offers a non-invasive, accessible tool for monitoring Parkinson’s Disease progression and evaluating therapeutic responses. By examining α-SYN-C levels in blood samples, our technology not only provides insights into PD mechanisms but also opens doors for developing targeted therapies that address the disease’s underlying pathology. Through this work, we aim to support more accurate PD diagnostics and more effective, individualized treatments in the fight against neurodegeneration.

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              Hidradenitis Suppurutiva (HS) is a sytemic disease with local manifestations

              Posted on by Claire Hornung

              Hi-drad-uh-NIE-tis sup-yoo-ruh-TIE-vuh – also known as hidradenitis suppurutiva (HS) – is a pathologically complicated skin condition, where chronic skin inflammation leads to abscesses and scarring. It is a systemic disease with local manifestations, meaning that the chronic insult to the skin is systemic, but it is physically located where skin rubs against skin, such as the armpits, groins and under the breasts. It is well known that immune cells, such as neutrophils and mast cells are involved, but what do we know about tissue remodeling?

              When the beautiful collagens of the skin become a part of disease pathogenesis

              Patients with HS not only experience pain from the neutrophil-rich tunnels but also from excessive tissue remodeling that causes scarring of the skin. These patients have an imbalance in tissue formation and tissue repair, partly due to the excessive activity of immune cells, which release enzymes that degrade the skin.

              One group of tissue-degrading enzymes are matrix metalloproteinases, abbreviated as MMPs. These are released by macrophages, the most numerous inflammatory cells found in HS patients. MMPs infiltrate and contribute to HS pathology, signaling that increased activity of MMPs degrades the proteins of the skin tissue, such as collagens. This process can be quantified by specific blood-based biomarker assays targeting this pathological process.

              Pathological fragments in HS may be used to identify disease types

              In HS, biomarkers of tissue remodeling such as type III collagen degraded by MMPs (C3M), are associated with disease severity (Hurley Staging).

              Figure 1. Biomarkers of tissue remodeling associate with Hurley Stages

              C3M is released upon MMP activation and measures dermal tissue remodeling. This raises the question – can we use C3M to identify subtypes of patients based on their disease activity, and potentially molecular endotypes to help select the right treatment for the patients?

              To address this, the levels of C3M are different depending on how active the disease is when divided into the Sartorious Score (HSS).

              Finding the patients with high C3M levels reflects high disease activity, and may indicate a different subtype of patients needing a different treatment type.

              Figure 2. Type II collagen degradation biomarker C3M as a patient stratification tool
              Browse our biomarker portfolio!

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                NordicPro-C3™ predictor of liver disease and alcohol-related liver disease

                Posted on by Claire Hornung

                Liver fibrosis is a progressive condition characterized by the excessive accumulation of scar tissue in the liver, often resulting from chronic liver diseases. Fibroblast activity plays a critical role in the progression of fibrosis, leading to organ function loss and liver-related complications. Liver fibrosis accounts for approximately 2 million deaths worldwide, while alcohol-related liver disease (ArLD) causes over 330,000 cirrhosis deaths globally every year.

                In two recent studies, we investigated the fibrogenesis biomarker nordicPRO-C3™ in the context of advanced liver disease and full-spectrum fibrosis in alcohol-related liver disease. Our goal was to assess the nordicPRO-C3™ biomarker’s potential prognostic value and clinical utility as a predictor of outcome, and our results are very promising.

                The nordicPRO-C3™ biomarker is capable of identifying advanced liver fibrosis and alcohol-related liver disease, providing a new clinical utility tool

                In the first paper, published in JHEP Reports, we conducted investigations using two distinct cohorts of patients with compensated cirrhosis of mixed etiologies. In both cohorts, a 2-fold increase in nordicPRO-C3™ at baseline was associated with a significant hazard increase for liver-related events. Notably, nordicPRO-C3™ exhibited prognostic significance.

                The identification of nordicPRO-C3™ as an independent prognostic factor for liver-related clinical outcomes has important implications for both drug development and clinical practice. By understanding the dynamic range of nordicPRO-C3™, researchers can improve its utility as a predictive marker in drug trials, enabling the development of targeted therapies to mitigate fibrosis progression and improve patient outcomes.

                In a clinical setting, the integration of nordicPRO-C3™ measurement alongside established markers such as fibrosis-4 index (FIB-4) or transient elastography (TE) may enhance risk stratification and inform treatment decisions. Early identification of patients at higher risk for liver-related events can facilitate timely interventions, such as disease monitoring, lifestyle modifications, and appropriate therapeutic interventions.

                In the second paper, published in Liver International, we assessed nordicPRO-C3™ models to predict liver-related events in patients with a history of excessive alcohol use but without a confirmed diagnosis of chronic liver disease. Our findings our promising for improving risk stratification and clinical outcomes in alcohol-related liver disease.

                A prospective cohort study involving patients with alcohol-related Liver Disease (ArLD), was conducted and divided into a derivation cohort of secondary care patients and a validation cohort of primary care patients. Baseline variables, including nordicPRO-C3™, were utilized to develop a prediction model known as the ALPACA score. The prognostic accuracy of the ALPACA score was compared to existing tools such as the enhanced liver fibrosis (ELF) test, FIB-4, TE, and the ADAPT score (developed for fatty liver disease).

                The ALPACA score demonstrated excellent discriminative accuracy in both the derivation and validation cohorts, comparable to TE and the ELF test, and superior to FIB-4, nordicPRO-C3™ alone, and the ADAPT score. Importantly, the ALPACA score provided reliable prognostic performance independent of the baseline fibrosis stage. This breakthrough has the potential to revolutionize risk stratification and patient management in primary and secondary care settings.

                NordicPRO-C3™ has recently become available on the Roche-COBAS high-precision platform, paving the way for its commercial availability worldwide in the near future. This accessibility will enable widespread adoption of nordicPRO-C3™-based scores, leading to improved risk prediction and better outcomes for individuals.

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                  Q2 2023 Publication Digest

                  Posted on by Claire Hornung

                  We have collected some of our best publications that we and our collaborators worked on in the second quarter of 2023—in no particular order. We invite you to browse and read according to your interests!

                  Hepatology

                  Alcohol-related liver disease (ArLD) leads to progressive liver-related outcomes and death, necessitating vigilant monitoring. Examining patients with ArLD over an average of 5.2 years, the PRO-C3-based score known as ALPACA (PRO-C3/AST/ALT, Platelets) demonstrated remarkable prognostic capability for liver-related events.

                  Comparatively, FIB-4, single markers like PRO-C3, ADAPT, ELF, and liver stiffness measures were all surpassed by the predictive efficacy of the ALPACA score in assessing outcomes for ArLD patients.

                  Read article

                  Respiratory

                  Fibronectin is a key protein for matrix organization and has been described as the glue of the extracellular matrix. The novel biomarker FN-EDB targets a degradation fragment of cellular fibronectin and showed to be elevated in patients with idiopathic pulmonary fibrosis.

                  This new biomarker enables quantification of a vital matrix embedded protein – laying the groundwork for important future studies.

                  Read article

                  Nephrology

                  In this study, we explored three collagen type III markers in the kidney’s interstitial matrix. These markers exhibited varied expressions and associations with inflammation, kidney function, and fibrosis in IgA nephropathy patients.

                  These findings emphasize the significance of selecting appropriate epitopes for distinct organs and diseases. Notably, urinary C3M emerges as a potential non-invasive fibrosis biomarker, complementing kidney biopsies in IgA nephropathy.

                  Read article

                  Nephrology

                  In our second renal publication, We examined whether collagen type III fragment C3M relates to inflammation markers and endothelial dysfunction, predicting chronic kidney disease (CKD) progression in type 2 diabetes patients with microalbuminuria.

                  Inflammatory markers and select endothelial indicators correlated with baseline serum C3M. Doubling serum C3M predicted CKD progression (accounting for mortality risk) post-conventional factor adjustment. These findings highlight serum C3M’s dual role as a CKD risk predictor and inflammation marker in type 2 diabetes.

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                    Serological biomarkers are different

                    Posted on by Claire Hornung

                    Biomarkers are more than just omics categories

                    Biomarkers aren’t just confined to different omics categories; various classes are referring to the types of serological measurements.

                    Consider cytokines, growth factors, receptors, kinases, transcription factors, intracellular proteins, extracellular proteins, and a subset within that—Extracellular Matrix (ECM) proteins. The common denominator in most pathologies is a loss of balance between different ECM proteins, especially collagens.

                    Biomarkers are more than just omics categories

                    This excessive destruction and deposition of proteins significantly propel the progression of end-stage diseases, culminating in organ dysfunction, failure, and, ultimately, death.

                    Diverse cytokines and growth factors orchestrating via specific receptors and kinases lead to ECM destruction and deposition, making ECM the converging pathway for multiple stimuli.

                    By the end of the day, what matters is to reverse ECM deterioration, or even undo, organ damage and function decline. Reversing organ damage can be achieved by stopping ECM deterioration. To truly reverse organ damage and restore organ functionality in patients, we need to repair the ECM to its normal balance.

                    We at Nordic Bioscience believe that the answer lies in effecting change at the tissue level—the key to reversing organ damage and, in turn, revitalizing organ function.

                    Have you considered if your treatment or pathway is affecting tissue formation or degradation? If so, feel free to browse our unique ECM biomarker portfolio.

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