<-  All posts

The Diagnostic Clues Hiding in Plain sight: What are Biomarkers?

Thursday 29 January, 2026      |     Read Time: 6 mins

‍Beth Wright

‍

‍

‍

Have you ever wished your body could just tell you when something’s wrong - before you even feel it?

That’s exactly what biomarkers do.

A biomarker - short for biological marker - is “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention.” [1]

Simply put they are the body’s built-in messengers - proteins, genes, lipids, or metabolites - tiny clues that can be found throughout the body, appearing in blood, saliva, nasal fluid, urine, and even in your spinal fluid.

For example, blood sugar (glucose) is a biomarker for diabetes - higher-than-normal levels can signal the disease and help doctors monitor how well treatment is working [2].

This simple definition however, does not do justice to the sheer complexity of these clues - and teams of research detectives are acting at this very moment to drastically improve our ability to read, recognise and understand them.

‍

Small but mighty: Biomarkers transform diagnosis by revealing hidden symptoms of disease

The activity of proteins, signalling molecules and genes often differ in your body when in different states of health or disease [3].

It is why, in so many research projects, that we compare healthy patients to patients suffering from disease. The difference is tangible - even if you cannot recognise it.

Even subtly different states of your body can be measured as biomarkers, and are highly important for individualised diagnosis.

‍

Why caring about biomarkers is vital for our survival

Detecting, measuring and understanding biomarkers is one the most essential components of personalised medicine - not just to diagnose [4].

Biomarkers reveal so much more than just whether someone is ‘sick’ or ‘healthy’. By measuring biomarkers, scientists and doctors can:

  • Determine whether someone will respond better to one medication over another
  • Detect specific subtypes of a disease in a patient
  • Help patients receive more accurate diagnosis, including subtypes of disease
  • Detect diseases early, sometimes before symptoms appear
  • Predict disease progression
  • Tailor treatments to individual patients
  • Monitor responses to treatment and therapies
  • Offer less-invasive diagnostic alternatives to standard techniques

Yet, despite how vital these diagnostic tools are, there’s still plenty of confusion about the terms surrounding biomarkers, what they mean and how they should be used.

Clear language is arguably one of the most important parts of scientific discovery.

It helps researchers communicate findings to make the journey from promising discoveries to real-world medical products much smoother.

The FDA has even acknowledged the challenge of biomarker language in creating the BEST resource (Biomarkers, EndpointS, and other Tools) to improve clarity and consistency across research and clinical practice [5,6].

‍

7 wonders of the human body - what are the types of biomarkers?

For doctors and researchers around the world, the one thing topping the 7 wonders of the natural world might be the 7 main categories of biomarkers defined by bodies such as the FDA [6].

These include:

  1. Susceptibility/Risk Biomarkers
  2. Diagnostic Biomarkers
  3. Prognostic Biomarkers
  4. Monitoring Biomarkers
  5. Predictive Biomarkers
  6. Pharmacodynamic/Response Biomarkers
  7. Safety Biomarkers

This list is not stagnant.

It is a living model that continues to evolve as our very understanding of the human body in states of health and disease rapidly advances day by day.

‍

Your body’s secret signals: A deep dive into the different types of biomarkers

  • ‍Susceptibility/Risk: Points to an underlying genetic risk for certain health conditions. For example, those carrying the APOE4 gene are at increased risks of Alzheimer's [7].‍
  • Diagnostic: Used to validate whether a disease or condition is present. For example, high levels of the protein Prostate-specific antigen (PSA) can suggest prostate cancer.‍
  • Prognostic: Forecasts how a disease is likely to progress. For example, high levels of certain proteins in a cancer patient can indicate tumour aggression, therapy resistance or increased chances of recurrence [8].
  • Monitoring: Looks at how a disease changes over time, including treatment response, stability, or relapse. For example, blood drug levels can track abstinence and treatment compliance in addiction studies.‍
  • Predictive: Indicates whether a patient is likely to benefit from, be neutral to or hindered by a specific therapy. For instance, specific gene mutations can help predict how patients may respond to cystic fibrosis treatments in clinical trials.‍
  • Pharmacodynamic/Response: Reveals the biological response or mechanism of a treatment. For instance, changing levels of circulating B cells can indicate how lupus patients respond to treatments [9].‍
  • Safety: Assesses potential side-effect risks or toxicity. For example, liver protein and biproduct levels can signal potential liver toxicity [10].

‍

Which category of biomarkers are we interested in at Diag-Nose?

Long story short: all of them.

At Diag-Nose, we’re on a mission to help patients find the right treatment faster so they can breathe easier and live longer. That’s why we explore biomarkers at every level.

Our RhinoMAP platform combines nasal microsampling, proteomics, and AI-powered algorithms to decode the biology of the airway. By focusing on root causes, we aim to prevent disease progression, improve patient outcomes, and deliver truly precision care for a healthier future.

With these insights, we can match patients to:

  • Highly specific diagnoses
  • The most effective treatments and therapeutics
  • Better ways to monitor treatment response and efficacy

‍

What’s next?

Biomarkers are transforming medicine from reactive to proactive.

‍These tiny biological messengers help us understand disease at its roots, giving us a window into what’s happening inside the body long before symptoms appear [5].

From circulating tumor DNA uncovering hidden cancers to the natural nitric oxide in your breath signaling airway inflammation, each biomarker tells a unique story about your health. By decoding these signals, researchers and doctors can detect disease earlier, predict how it might progress, tailor treatments to the individual, and monitor responses with greater precision.

At Diag-Nose, this means accelerating research efforts and using platforms like RhinoMAP to unlock insights that help patients breathe better, respond faster to treatment, and live healthier, longer lives.

In the future, listening to the language of the body won’t just inform care - it will prevent disease before it even starts.

‍

‍

‍

References

1.FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD): Food and Drug Administration (US); Bethesda (MD): National Institutes of Health (US), www.ncbi.nlm.nih.gov/books/NBK326791/

2.Sapra A, Bhandari P. Diabetes. [Updated 2023 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551501/

3. Henry, N. L., & Hayes, D. F. (2012). Cancer biomarkers. Molecular oncology, 6(2), 140–146. doi: https://doi.org/10.1016/j.molonc.2012.01.010

4. W. Ken Redekop, Deirdre Mladsi (2013). The Faces of Personalized Medicine: A Framework for Understanding Its Meaning and Scope. Value in Health. 16(6);S4-S9. doi:https://doi.org/10.1016/j.jval.2013.06.005

5.Califf R. M. (2018). Biomarker definitions and their applications. Experimental biology and medicine (Maywood, N.J.), 243(3), 213–221. https://doi.org/10.1177/1535370217750088

6. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326791/ Co-published by National Institutes of Health (US), Bethesda (MD).

7.Hunsberger, H. C., Pinky, P. D., Smith, W., Suppiramaniam, V., & Reed, M. N. (2019). The role of APOE4 in Alzheimer's disease: strategies for future therapeutic interventions. Neuronal signaling, 3(2), NS20180203. https://doi.org/10.1042/NS20180203

‍8. Feng, W., Dean, D. C., Hornicek, F. J., Spentzos, D., Hoffman, R. M., Shi, H., & Duan, Z. (2020). Myc is a prognostic biomarker and potential therapeutic target in osteosarcoma. Therapeutic advances in medical oncology, 12, 1758835920922055. https://doi.org/10.1177/1758835920922055 (Retraction published Ther Adv Med Oncol. 2023 Apr 22;15:17588359231172420. doi: 10.1177/17588359231172420.)

9. Stohl, W., & Hilbert, D. M. (2012). The discovery and development of belimumab: the anti-BLyS-lupus connection. Nature biotechnology, 30(1), 69–77. https://doi.org/10.1038/nbt.2076

10. Senior J. R. (2014). Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges. Drug safety, 37 Suppl 1(Suppl 1), S9–S17. https://doi.org/10.1007/s40264-014-0182-7

‍

‍

About Diag-Nose.io

Diag-Nose.io, founded in 2020, is a TechBio company focused on translating the complexities of the unified airway into precision diagnostic and drug discovery solutions.

Their precision medicine technology combines advanced proteomics, computational biology, and AI (machine learning) to create a scalable respiratory biology model. This innovation aims to help clinicians prescribe the right treatments faster and enable researchers to accelerate the development of new therapies.

The company’s flagship platform, RhinoMAP™, leverages proteomic data to predict respiratory disease activity, monitor therapy response and predict treatment efficacy in advance, with an initial focus on anti-Th2 biologics.

Learn more at Diag-Nose.io

About the author

Beth Wright

Junior Researcher

Beth Wright, a Junior Researcher at Diag-Nose, expertly aims to improve accessibility of medical information and research in the field of Respiratory Disease.

Beth holds a BBiomedSc. from Monash University.

Thursday 29 January, 2026      |     Read Time: 6 mins

‍Beth Wright

‍

‍

‍

Have you ever wished your body could just tell you when something’s wrong - before you even feel it?

That’s exactly what biomarkers do.

A biomarker - short for biological marker - is “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention.” [1]

Simply put they are the body’s built-in messengers - proteins, genes, lipids, or metabolites - tiny clues that can be found throughout the body, appearing in blood, saliva, nasal fluid, urine, and even in your spinal fluid.

For example, blood sugar (glucose) is a biomarker for diabetes - higher-than-normal levels can signal the disease and help doctors monitor how well treatment is working [2].

This simple definition however, does not do justice to the sheer complexity of these clues - and teams of research detectives are acting at this very moment to drastically improve our ability to read, recognise and understand them.

‍

Small but mighty: Biomarkers transform diagnosis by revealing hidden symptoms of disease

The activity of proteins, signalling molecules and genes often differ in your body when in different states of health or disease [3].

It is why, in so many research projects, that we compare healthy patients to patients suffering from disease. The difference is tangible - even if you cannot recognise it.

Even subtly different states of your body can be measured as biomarkers, and are highly important for individualised diagnosis.

‍

Why caring about biomarkers is vital for our survival

Detecting, measuring and understanding biomarkers is one the most essential components of personalised medicine - not just to diagnose [4].

Biomarkers reveal so much more than just whether someone is ‘sick’ or ‘healthy’. By measuring biomarkers, scientists and doctors can:

  • Determine whether someone will respond better to one medication over another
  • Detect specific subtypes of a disease in a patient
  • Help patients receive more accurate diagnosis, including subtypes of disease
  • Detect diseases early, sometimes before symptoms appear
  • Predict disease progression
  • Tailor treatments to individual patients
  • Monitor responses to treatment and therapies
  • Offer less-invasive diagnostic alternatives to standard techniques

Yet, despite how vital these diagnostic tools are, there’s still plenty of confusion about the terms surrounding biomarkers, what they mean and how they should be used.

Clear language is arguably one of the most important parts of scientific discovery.

It helps researchers communicate findings to make the journey from promising discoveries to real-world medical products much smoother.

The FDA has even acknowledged the challenge of biomarker language in creating the BEST resource (Biomarkers, EndpointS, and other Tools) to improve clarity and consistency across research and clinical practice [5,6].

‍

7 wonders of the human body - what are the types of biomarkers?

For doctors and researchers around the world, the one thing topping the 7 wonders of the natural world might be the 7 main categories of biomarkers defined by bodies such as the FDA [6].

These include:

  1. Susceptibility/Risk Biomarkers
  2. Diagnostic Biomarkers
  3. Prognostic Biomarkers
  4. Monitoring Biomarkers
  5. Predictive Biomarkers
  6. Pharmacodynamic/Response Biomarkers
  7. Safety Biomarkers

This list is not stagnant.

It is a living model that continues to evolve as our very understanding of the human body in states of health and disease rapidly advances day by day.

‍

Your body’s secret signals: A deep dive into the different types of biomarkers

  • ‍Susceptibility/Risk: Points to an underlying genetic risk for certain health conditions. For example, those carrying the APOE4 gene are at increased risks of Alzheimer's [7].‍
  • Diagnostic: Used to validate whether a disease or condition is present. For example, high levels of the protein Prostate-specific antigen (PSA) can suggest prostate cancer.‍
  • Prognostic: Forecasts how a disease is likely to progress. For example, high levels of certain proteins in a cancer patient can indicate tumour aggression, therapy resistance or increased chances of recurrence [8].
  • Monitoring: Looks at how a disease changes over time, including treatment response, stability, or relapse. For example, blood drug levels can track abstinence and treatment compliance in addiction studies.‍
  • Predictive: Indicates whether a patient is likely to benefit from, be neutral to or hindered by a specific therapy. For instance, specific gene mutations can help predict how patients may respond to cystic fibrosis treatments in clinical trials.‍
  • Pharmacodynamic/Response: Reveals the biological response or mechanism of a treatment. For instance, changing levels of circulating B cells can indicate how lupus patients respond to treatments [9].‍
  • Safety: Assesses potential side-effect risks or toxicity. For example, liver protein and biproduct levels can signal potential liver toxicity [10].

‍

Which category of biomarkers are we interested in at Diag-Nose?

Long story short: all of them.

At Diag-Nose, we’re on a mission to help patients find the right treatment faster so they can breathe easier and live longer. That’s why we explore biomarkers at every level.

Our RhinoMAP platform combines nasal microsampling, proteomics, and AI-powered algorithms to decode the biology of the airway. By focusing on root causes, we aim to prevent disease progression, improve patient outcomes, and deliver truly precision care for a healthier future.

With these insights, we can match patients to:

  • Highly specific diagnoses
  • The most effective treatments and therapeutics
  • Better ways to monitor treatment response and efficacy

‍

What’s next?

Biomarkers are transforming medicine from reactive to proactive.

‍These tiny biological messengers help us understand disease at its roots, giving us a window into what’s happening inside the body long before symptoms appear [5].

From circulating tumor DNA uncovering hidden cancers to the natural nitric oxide in your breath signaling airway inflammation, each biomarker tells a unique story about your health. By decoding these signals, researchers and doctors can detect disease earlier, predict how it might progress, tailor treatments to the individual, and monitor responses with greater precision.

At Diag-Nose, this means accelerating research efforts and using platforms like RhinoMAP to unlock insights that help patients breathe better, respond faster to treatment, and live healthier, longer lives.

In the future, listening to the language of the body won’t just inform care - it will prevent disease before it even starts.

‍

‍

‍

References

1.FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD): Food and Drug Administration (US); Bethesda (MD): National Institutes of Health (US), www.ncbi.nlm.nih.gov/books/NBK326791/

2.Sapra A, Bhandari P. Diabetes. [Updated 2023 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551501/

3. Henry, N. L., & Hayes, D. F. (2012). Cancer biomarkers. Molecular oncology, 6(2), 140–146. doi: https://doi.org/10.1016/j.molonc.2012.01.010

4. W. Ken Redekop, Deirdre Mladsi (2013). The Faces of Personalized Medicine: A Framework for Understanding Its Meaning and Scope. Value in Health. 16(6);S4-S9. doi:https://doi.org/10.1016/j.jval.2013.06.005

5.Califf R. M. (2018). Biomarker definitions and their applications. Experimental biology and medicine (Maywood, N.J.), 243(3), 213–221. https://doi.org/10.1177/1535370217750088

6. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326791/ Co-published by National Institutes of Health (US), Bethesda (MD).

7.Hunsberger, H. C., Pinky, P. D., Smith, W., Suppiramaniam, V., & Reed, M. N. (2019). The role of APOE4 in Alzheimer's disease: strategies for future therapeutic interventions. Neuronal signaling, 3(2), NS20180203. https://doi.org/10.1042/NS20180203

‍8. Feng, W., Dean, D. C., Hornicek, F. J., Spentzos, D., Hoffman, R. M., Shi, H., & Duan, Z. (2020). Myc is a prognostic biomarker and potential therapeutic target in osteosarcoma. Therapeutic advances in medical oncology, 12, 1758835920922055. https://doi.org/10.1177/1758835920922055 (Retraction published Ther Adv Med Oncol. 2023 Apr 22;15:17588359231172420. doi: 10.1177/17588359231172420.)

9. Stohl, W., & Hilbert, D. M. (2012). The discovery and development of belimumab: the anti-BLyS-lupus connection. Nature biotechnology, 30(1), 69–77. https://doi.org/10.1038/nbt.2076

10. Senior J. R. (2014). Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges. Drug safety, 37 Suppl 1(Suppl 1), S9–S17. https://doi.org/10.1007/s40264-014-0182-7

‍

‍

About Diag-Nose.io

Diag-Nose.io, founded in 2020, is a TechBio company focused on translating the complexities of the unified airway into precision diagnostic and drug discovery solutions.

Their precision medicine technology combines advanced proteomics, computational biology, and AI (machine learning) to create a scalable respiratory biology model. This innovation aims to help clinicians prescribe the right treatments faster and enable researchers to accelerate the development of new therapies.

The company’s flagship platform, RhinoMAP™, leverages proteomic data to predict respiratory disease activity, monitor therapy response and predict treatment efficacy in advance, with an initial focus on anti-Th2 biologics.

Learn more at Diag-Nose.io

About the author

Beth Wright

Junior Researcher

Beth Wright, a Junior Researcher at Diag-Nose, expertly aims to improve accessibility of medical information and research in the field of Respiratory Disease.

Beth holds a BBiomedSc. from Monash University.