Understanding biomarkers and their relevance
Biomarker, which is a portmanteau word (a combination of two terms) of biological marker, is a characteristic of our body or metabolism that can be measured accurately and reproducibly; an indication that a biological process in the body has happened or is ongoing. Normally used in plural, biomarkers, this term refers to objective medical signs, not symptoms, that can be observed by a doctor on a patient during an outside exploration.
There are some definitions within the scientific literature, but the World Health Organization (WHO) has decided to consider biomarkers “almost any measurement reflecting an interaction between a biological system and a potential hazard, which may be chemical, physical, or biological. The measured response may be functional and physiological, biochemical at the cellular level, or a molecular interaction.”
Pulse or blood pressure are some examples of biomarkers as well as an increase of the heart rate after doing exercise or complex blood tests developed in laboratories.
Why are biomarkers so important?
To understand the relevance of biomarkers we can take a look to the pharmacological industry. When developing a new drug, it need to be tested on people during clinical trials to improve the failure rate and to accelerate the treatment availability. Biomarkers are crucial because the effects of the investigational drug are checked on biomarkers. That is why for the Food & Drug Administration it is necessary to have a wide range of new biomarkers.
For the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), Janet Woodcock: “To really improve the success rate and improve the efficiency of drug development, we need a whole new generation of biomarkers that are more informative and that can tell developers earlier whether or not their drug may have toxicity or it really may not work at all, and to get that early read on what’s going to be successful. And so those biomarkers are ones that have yet to be developed”.
Biomarkers are present in all our body including body fluids and tissues. A wide range of technologies is utilized for detection of biomarkers like blood and urine analysis developed in laboratories, imaging studies or examination of body tissues (biopsies). Even exhaled breath contains biomarkers that can be discovered using different techniques or technologies like Secondary Electro-Spray Ionization and Mass Spectrometry (enlace a Solution for Breath Analysis page).
Once they are discovered biomarkers should pass de Biomarkers Qualification Process (BQP) to be qualified by de FDA.
If you want to know more about biomarkers, we have included in this post a couple of videos by de FDA and The Washington Post that clearly explains about biomarkers and their relevance for the medical and the pharmacokinetics fields.