In Vitro Diagnostic product (IVD) Approval in 2022 - CLSI Standards Regulatory Landscape

Watch and understand how In Vitro Diagnostic Products can be approved in 2022 based on the CLSI standards regulatory landscape.
This presentation was presented by Elisabeth Erhardsen at the ECM Symposium 2021 organized by Nordic Bioscience.
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Nordic Bioscience is the leading expert in extracellular matrix (ECM) research with 30+ years of experience in biomarker development, pre-clinical and clinical research. With more than 575 peer-reviewed publications, our science-driven approach has been the evolving force behind our decades of success.
Through our Protein Fingerprint technology, we identify fragments of the 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.
Nordic Bioscience is headquartered in Herlev, Denmark, with a high-quality standard laboratory, running clinical trials under Good Clinical Laboratory Practice (GCLP) with accreditation by the College of American Pathologists (CAP) and ISO9001 certificate. Everything in our laboratory supports compliance to FDA 21 CFR Part 11. We employ more than 180 people who are dedicated to improving patient management for a broad range of therapeutic areas including Hepatology, Rheumatology, Dermatology, Oncology, Gastroenterology, Respiratory, Neurodegenerative and Cardiovascular diseases.
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