Low reproducibility rates within life science measurements undermine the replication of data and hinder scientific progress, contributing to costly delays to research and product development.
The European-funded (EMPIR) project Bio-stand aims to use outputs from recently completed European metrology projects (Bio-SITrace, INFECT-MET) to develop new and revised standards to support improved measurement comparability for biotechnology and in vitro diagnostics.
This will help the biotechnology industry optimise and assess their processes, enabling data comparability, reducing risks and costs and ultimately supporting regulatory confidence and compliance to facilitate international trade. In addition, the standards developed will support molecular diagnostic laboratories to demonstrate conformity with in vitro diagnostic regulatory requirements worldwide.
Accurate measurement of biological analytes (nucleic acids, proteins and cells) underpins the future of many sectors, including healthcare, environment, biotechnology and food. For example, decisions on whether a drug should be progressed from research in to industry or the clinic are increasingly being based on ever-more subtle changes of ever-smaller components of increasingly complex biological systems.
However, there is currently a lack of reference methods and standards to support the comparability and traceability of these measurements. This delays translation from research in to the clinic and impacts upon accreditation, regulatory development and compliance. This in turn influences efficacy of products and compromises patient and consumer safety.
Bio-stand will work closely with the ISO committees for biotechnology (ISO TC 276) and Clinical laboratory testing and in vitro diagnostic test systems (ISO TC 212) to develop the standards and guidance documents needed to support the progress of biotechnology and clinical diagnostics and mitigate the use of inaccurate and unreliable tests.
The consortium delivering Bio-stand brings together two well-established National Measurements Institute/Designated Institute partners: NML at LGC and PTB, both with close links to the standards organisations DIN and ISO.