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Case Study – A Blood-based Biomarker Panel For Non-invasive Diagnosis Of Non-alcoholic Steatohepatitis: A Multi-centre Prospective And Validation Study

A late-stage biopharmaceutical company dedicated to metabolic and chronic liver diseases is developing an in vitro diagnostic (IVD) test for NASH at-risk patients. The test integrates four independent biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c. The output is a 0-10 score with threshold values, identifying patients with low risk or high risk of developing NASH.

The main objective of this study is to evaluate the physiological stability of these biomarkers between the fed and fasting state in patients with the target condition (NAFLD) over a 30-day period.

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Flyer – The New Big Data Application That Is Reshaping Clinical Trials

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White Paper – IVDR: How To Prepare For New Regulations And Move Successfully To CE Mark

The new Vitro Diagnostic Regulation legislation comes into force on May 26, 2022. Diagnostic device manufacturers are working hard to ensure design, manufacturing, and post-market surveillance and vigilance of their products comply with the new regulations. As the clock ticks, few manufacturers are fully prepared: according to a survey conducted by MedTech Summit and NSF in early 2021, only 15% of respondent organizations were fully prepared to meet the IVDR deadline.

One of the main reasons for the delay was COVID-19. Almost all (95%) of respondents said the pandemic had impacted their IVDR implementation. While the European Commission recently proposed to adapt the full IVDR mandatory application dates depending on the class of medical device, organizations that are not already working with a Notified Body on CE mark submission may have a tough few years ahead. Download our whitepaper to find out more from Cerba Research.

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