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Biomedica Service Measurements
Are you running a study and require quick and reliable results?
We at Biomedica offer custom analytical testing services for ELISA Kits, Luminex Assays, microRNA Analysis, and Glycan Profiling.
Biomedica Service Measurements
Biomedica Service Measurements – your benefits:
• Expertise: Experienced laboratory staff with hands-on know
• Quality: Highest quality equipment
• Flexibility: Customized according to your project needs and budget
• Speed: Rapid turn-around time to meet your deadlines
• Results: Verified and comprehensive results presented in an analytical report
To learn more about the Biomedica Service Measurements click here
RELATED PUBLICATIONS
Clinical biomarker validation. Allinson JL. Bioanalysis. 2018 Jun 1;10(12):957-968. doi: 10.4155/bio-2018-0061. Epub 2018 Jun 20. PMID: 29923754.
Abstract
Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally, this article reviews the different types of analytical laboratories and their practices and case studies will demonstrate the potential outcomes of using biomarker assays in drug development when they are not validated correctly.
Pre-analytical processes in medical diagnostics: New regulatory requirements and standards. Dagher G, Becker KF, Bonin S, Foy C, Gelmini S, Kubista M, Kungl P, Oelmueller U, Parkes H, Pinzani P, Riegman P, Schröder U, Stumptner C, Turano P, Sjöback R, Wutte A, Zatloukal K.N Biotechnol. 2019 Sep 25;52:121-125. doi: 10.1016/j.nbt.2019.05.002. Epub 2019 May 15. PMID: 31102798.
Abstract
In May 2017, the European In Vitro Diagnostic Regulation (IVDR) entered into force and will apply to in vitro diagnostics from May 26th, 2022. This will have a major impact on the in vitro diagnostics (IVD) industry as all devices falling under the scope of the IVDR will require new or re-certification. It will also affect health institutions developing and using in-house devices. The IVDR also has implications with respect to product performance validation and verification including the pre-analytics of biological samples used by IVD developers and diagnostic service providers. In parallel to the IVDR, a series of standards on pre-analytical sample processing has been published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). These standards describe pre-analytical requirements for various types of analyses in various types of biospecimens. They are of relevance for IVD product developers in the context of (re)certification under the IVDR and to some extent also to devices manufactured and used only within health institutions. This review highlights the background and the rational for the pre-analytical standards. It describes the procedure that leads to these standards, the major implications of the standards and the requirements on pre-analytical workflows. In addition, it discusses the relationship between the standards and the IVDR.