A ‘biomarker’ is a characteristic that is objectively measured and can be viewed as an indicator of a normal biological process, a disease process, or a typical response to a drug or therapy; for example, blood pressure.
The generally accepted classification of biomarkers divides them into three main categories: biomarkers of exposure, biomarkers of effect, and biomarkers of susceptibility. Biomarkers fulfil a role in the continuum from exposure to effect and they can be used to inform (early) effects and to study the effects of an exposure or intervention. Aided by novel profiling technologies, the biomarker research field is undergoing rapid development and new putative biomarkers are continuously emerging in the scientific literature. Biomarkers of effect (‘reduction of a risk factor’) are also a legal requirement for the scientific substantiation of health claims under Regulation (EC) 1924/2006.
Measuring a biomarker in e.g. human blood, urine, hair etc. requires a prudent and well thought-through approach: “Just measuring substances in blood or urine, is a waste of energy and resources, and scientifically wrong. The challenges are to measure the right biomarker, in the right place, at the right moment and with validated analytical methods.” (Verhagen et al. 2018)
Any biomarker requires validation, as well as standardisation and harmonisation. Analytical validation can be done along recommendations such as those under the 17025/2017 system, which contribute to the reliability of the results being produced. Physiological validation is the scientific justification of the biomarker measured and its response to changes in exposure or effect, such as used for the scrutiny of scientific substantiation of health claims.
Detailed information can be found:
- HBM4EU project (https://www.hbm4eu.eu/)
- Foodball EU project (https://foodmetabolome.org/)
- Eurofeda EU project (https://pubmed.ncbi.nlm.nih.gov/12079769/)
- ‘reduction of a risk factor’ for health claims: EFSA (https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4680), EU (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1924&from=en)
What do I offer
- Framing and designing of biomarker/biomonitoring projects for regulated products.
- Execution of biomarker/biomonitoring projects for regulated products, publication and presentation of results.
- Scientific presentations on biomarkers/biomonitoring.
- Advising on ‘reduction of a risk factor’ / biomarker in relation to scientific substantiation of health claims.
- Collaboration in (EU) projects as an SME.
Expertise with the topic
- (Co-)author of dozens of publications on biomarker/biomonitoring.
- Supervising PhD student on intake of biomarkers of artificial sweeteners (2014-2016).
- Steering committee member of various EU projects (Biomarkers 1997-2001), Eurofeda (2001-2005), Foodball 2015-2019.
- EFSA representative in the HBM4EU project: Governing Board member, Policy Board member
Some key publications in the area
- Zare Jeddi M. , Hopf N.B., Viegas S., Bal Price A., Paini A., van Thriel C., Benfenati E., Ndaw S., Bessems J., Behnisch P.A., Leng G., Duca R-C., Verhagen H., Cubadda F., Brennan L., Ali I., David A., Mustieles V., Fernandez M.F., Louro H., Pasanen-Kase R. (2021). Towards a systematic use of effect biomarkers in population and occupational biomonitoring. Environment International, 146: 106257. https://doi.org/10.1016/j.envint.2020.106257
- Viegas S., Zare Jeddi M., B. Hopf N.B., Bessems J., Palmen N., Galea K.S., Jones K., Duca R.C., Kujath P., Verhagen H., Santonen T., Pasanen-Kase R. (2020). Biomonitoring as an underused exposure assessment tool in Occupational Safety and Health context – Challenges and way forward! Int. J. Environ. Res. Public Health, 17, 5884
- Logue C., Dowey L.R.C., Verhagen H. Strain JJ, O’Mahony M, Kapsokefalou M, Athanasatou A, Gallagher AM (2020). A novel urinary biomarker approach reveals widespread exposure to multiple low-calorie sweeteners in adults. The Journal of Nutrition (2435–2441).
- Logue C., Dowey L.R.C., Strain J.J., Verhagen H., Gallagher A.M. (2017). Application of Liquid Chromatography-Tandem Mass Spectrometry To Determine Urinary Concentrations of Five Commonly Used Low-Calorie Sweeteners: A Novel Biomarker Approach for Assessing Recent Intakes? J Agric Food Chem. 2017 Jun 7;65(22):4516-4525. doi: 10.1021/acs.jafc.7b00404
- Gao Q., Praticò G., Scalberg A., Vergères G., Kolehmainen M., Manach C., Brennan L., Afman L., Wishart S., Lacueva C., Garcia-Aloy M., Verhagen H., Feskens E., Dragsted L. (2017). A scheme for a flexible classification of dietary and health biomarkers. Gao et al. Genes & Nutrition. DOI 10.1186/s12263-017-0587-x
- Praticò G., Gao Q., Scalbert A., Vergères G., Kolehmainen M., Manach C., Brennan L., Pedapati S., Afman L., Wishart D., Fresno R., Lacueva C., Garcia-Aloy M., Verhagen H., Feskens E., Dragsted L. (2018) Guidelines for Biomarker of Food Intake Reviews (BFIRev): how to conduct an extensive literature search for biomarker of food intake discovery. Genes & Nutrition https://doi.org/10.1186/s12263-018-0592-8
- Dragsted L., Gao Q., Scalbert A., Vergères G., Kolehmainen M., Manach C., Brennan L., Afman L., Wishart D., Lacueva C., Garcia-Aloy M., Verhagen H., Feskens E., Praticò G. (2018) Validation of biomarkers of food intake—critical assessment of candidate biomarkers. Genes & Nutrition https://doi.org/10.1186/s12263-018-0603-9
- Verhagen H., Coolen S., Duchateau G., Hamer M., Kyle J., Rechner A. (2004). Assessment of the efficacy of functional food ingredients – introducing the concept “kinetics of biomarkers”. Mutation Research 551, 65-78.
- Griffiths HR, Moller L, Bartosz G, Bast A, Bertoni-Freddari C, Collins A, Cooke M, Coolen S, Haenen G, Hoberg AM, Loft S, Lunec J, Olinski R, Parry J, Pompella A, Poulsen H, Verhagen H, Astley SB (2002). Biomarkers. Mol. Aspects. Med. 1-3: 101-208.
- Crews H, Alink G, Andersen R, Braesco V, Holst B, Maiani G, Ovesen L, Scotter M, Solfrizzo M, van Den Berg R, Verhagen H, Williamson G.(2001): “A critical assessment of some biomarker approaches linked with dietary intake.” Brit.J. Nutrition 86, supplement 1: S37-S53.
- Branca F, Hanley AB, Pool-Zobel B, Verhagen H. (2001): “Biomarkers in disease and health”. Brit.J. Nutrition 86, supplement 1: S55-S92.