Metanomics Health Announces MxP® Quality Control Plasma:
The First Validated Assay for Holistic Human Plasma Quality Control

Summary: Metanomics Health has introduced a novel metabolomics-based profiling assay (MxP® Quality Control Plasma), which provides holistic control of EDTA human plasma. It is the first assay to identify pre-analytic deviations and error location at three checkpoints along the workflow. The MxP QCP permits quality checks to be applied to banked samples of unknown SOPs, thereby improving biomarkers, companion diagnostics, molecular diagnostics and all clinical research across pharmaceutical R&D and biomarker development.

Human Plasma Quality Control

Unacceptable sample quality, due to failures in the pre-analytical phase and/or improper sample storage in retrospect research studies, is a well-known challenge in biomedical R&D. With sample quality being a critical determinant of success, it is essential for systems biology approaches – metabolomics methods and biobanking – to not only ensure sample quality, but to control it.

For the first time, Metanomics Health has developed MxP® Quality Control Plasma, a novel metabolomics-based profiling assay, that provides holistic control of EDTA human plasma sample quality. The new MxP Quality Control Plasma measures specifically-developed and validated metabolomics biomarkers in single read-outs.

Metabolite levels in the blood cover a range of physiological and chemical processes, and are highly reactive to disturbances.  Analysis of the responsiveness of the human plasma metabolome to pre-analytic variations allows the most comprehensive and sensitive read-out of sample quality.

By applying proprietary algorithms, three different test results are calculated which provide both precise assessments of sample quality and ‘fit for purpose’ suggestions for sample utilization.  A blinded study conducted by Bayer Pharma AG found that the MxP Quality Control Plasma performed with 98% sensitivity and 90% specificity.  In addition, usage of different blood collection tubes was correctly assigned 100% of the time.

MxP® Quality Control Plasma covers the whole blood collection and handling process, through to plasma, by delivering 3 test results:

1. MxP QC Collection Tube Control – Tests types of additives in collection tubes before blood withdrawal
2. MxP QC Blood Processing Control – Tests for differences in time and temperature during blood processing
3. MxP QC Plasma Processing Control – Recognizes disturbances caused by pipetting, as well as by storage time and temperature

The MxP assay report combines values from steps 2 and 3 into a combined MxP QS (quality score) to give intuitive color-coded quality categories (high quality, medium quality or low quality) and, depending on the MxPQS, provides recommendations for sample utilization. MxP can determine the level of quality of banked samples, as well as ongoing sample monitoring, and recommendations for which samples could be analyzed in highly-sensitive, downstream environments, and which should be analyzed in less sensitive environments.  For the first time, users can now filter out poor quality metabolites, protein/peptides, RNA or DNA samples, thereby improving the accuracy of research.

Figure Description: Example of a beneficial effect of sample quality control in a biomarker identification study

 

“The MxP® Quality Control Plasma will benefit all who are involved in companion diagnostic, molecular diagnostic and overall biomedical research and clinical trials, including CROs and biobanks, said Dr. Beate Kamlage, who is head of the project.  “Quality control is crucial to cost-effective decision-making in pharma.  For the first time, we can identify the quality of samples when lacking paper-documented quality assurance.”

The MxP® Quality Control Plasma is offered as both a licensed assay and through Metanomics Health as a fee-for-service.

To learn more about the Metanomics Health MxP® Quality Control Plasma, visit Metanomics Health’s website.