Biomarkers and Bio-Signatures: How to Read the Difference

What is a biomarker?

A biomarker is a defined characteristic measured as an indicator of a biological process or a response to an exposure or intervention. The FDA’s explanation of the BEST terminology includes molecular, physiological and imaging characteristics [1].

The word alone does not tell you what a result can establish. Its meaning depends on the measurement method and the intended use. A biomarker used in research is not automatically a validated diagnostic test.

A signal is not always an identified molecule

Metabolomics studies small molecules involved in biological processes. In an untargeted analysis, instruments record many features. Identifying a molecule and interpreting its role require additional work and evidence [2].

A count of instrument signals must therefore not be read as the same number of distinct, identified biomarkers or clinical tests. More signals do not, on their own, demonstrate better health information.

Where Bio-Signatures fit

Each BioTwin and TwinMe program organizes its results into Bio-Signatures. A Bio-Signature is computed by a statistical algorithm from biomarkers associated with the same dimension of health or well-being, making results easier to understand and track over time.

This grouping helps connect detailed results to the topic of a program, such as nutrition or recovery. The program descriptions specify the analyses included; one kit does not automatically include every program.

A TwinMe wellness Bio-Signature is not a clinical laboratory panel. A score or visual zone should not be interpreted as a diagnosis, a clinical concentration or a treatment threshold.

Four questions to ask about a result

1. What was measured? Distinguish the sample, the measured signal and the interpretation derived from it.
2. What was the context? Note collection conditions and relevant changes in habits, health or medication.
3. What does the comparison mean? An earlier result and a reference group answer different questions.
4. What can the result support? A wellness observation can help frame a question; it does not establish a disease or a nutrient deficiency.

Repeat observations may reveal a trend, but a change cannot be attributed to one habit without considering other explanations. Follow the sampling instructions for your program and discuss medical concerns with a qualified professional.

Sources

1. FDA. About Biomarkers and Qualification, explanation of the FDA-NIH BEST terminology.
2. Sumner LW et al. Proposed minimum reporting standards for chemical analysis. Metabolomics, 2007. doi:10.1007/s11306-007-0082-2.