Nordic Bioscience's Innovative CPa9-HNE Biomarker Gains FDA Support

Nordic Bioscience Receives FDA Letter of Support for CPa9-HNE

Nordic Bioscience is making significant strides in the field of biomarkers with the recent announcement of receiving a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA) for its CPa9-HNE biomarker. This recognition marks an important milestone for the company, highlighting its contribution to the management of inflammatory bowel diseases (IBD).

Advancements in Biomarker Technology

With over three decades of experience, Nordic Bioscience has established itself as a prominent player within the biomarker sector, particularly through its proprietary ProteinFingerprint Biomarker Technology™. This technology has been propelled by innovative scientific breakthroughs documented in reputable journals and the development of high-precision automated instruments.

Importance of CPa9-HNE

The CPa9-HNE biomarker is crucial in identifying a specific fragment of calprotectin S100A9, which is produced by human neutrophil elastase. By measuring this biomarker in serum and plasma, clinicians can gain insight into the levels of neutrophil activation present in individuals suffering from IBD. This offers a non-invasive avenue for assessing disease activity, an invaluable tool in clinical settings.

Potential Impacts on IBD Trials

In clinical trials focusing on IBD, particularly those evaluating treatments for moderate to severe ulcerative colitis or Crohn's disease, CPa9-HNE serves as a significant resource. The involvement of neutrophils — immune cells that play a key role in IBD — aligns with the growing understanding that this biomarker can be instrumental in monitoring disease activity effectively.

Future Prospects for CPa9-HNE

Morten A. Karsdal, CEO of Nordic Bioscience, expressed pride in the achievement, stating, "This trifecta of scientific excellence, high-quality biomarkers, and regulatory support sets us apart from the competition. The CPa9-HNE Letter of Support is not only another landmark achievement signifying our success story, but also something that our hard-working teams can be very proud of." This testament underscores the aspirations Nordic Bioscience has for the CPa9-HNE biomarker.

Scientific Director of Gastrointestinal Diseases at Nordic Bioscience, Joachim Høg Mortensen, added, "The Letter of Support underlines what we have sought to achieve with CPa9-HNE: this marker has the potential to be applied as a patient-enriching tool for clinical trials in the future, by identifying patients more likely to have moderate or severe endoscopic disease activity. This can significantly streamline patient recruitment, ensuring you target the right profiles. In addition, CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity, and has the potential to be used for monitoring disease activity and treatment response.”

Navigating the Regulatory Landscape

Nordic Bioscience’s commitment to innovation is evident, having previously secured FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The company has also transitioned the FDA-approved bone biomarker CTX-I and the fibrogenesis biomarker PRO-C3 to the Roche COBAS platform, showcasing its dedication to rigorous scientific standards.

Extensive ELISA Biomarkers Portfolio

With a remarkable portfolio featuring over 125 ELISA biomarkers, Nordic Bioscience’s tools facilitate critical roles across various stages of drug development and patient selection for a wide array of diseases. Their continuous focus on delivering precise biomarkers is a testament to their commitment to improving patient outcomes.

Contact and Engagement Information

For further inquiries, the designated contact at Nordic Bioscience is Elijah Aighobahi, who can be reached via telephone at +45 4452 5252.

Frequently Asked Questions

What is the significance of the CPa9-HNE biomarker?

The CPa9-HNE biomarker aids in measuring neutrophil activation, providing insight into disease activity in IBD patients.

How does Nordic Bioscience's technology work?

The technology focuses on analyzing protein fragments to understand biological processes, particularly related to diseases.

What are the future applications of the CPa9-HNE biomarker?

It is expected to enhance clinical trials by identifying suitable patient profiles for studies in IBD.

How does CPa9-HNE contribute to patient monitoring?

CPa9-HNE serves as a non-invasive blood marker reflecting disease activity, supporting better management of IBD.

Who can be contacted for more information about Nordic Bioscience?

Elijah Aighobahi is the contact person for inquiries related to Nordic Bioscience, reachable at +45 4452 5252.

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