Biomarkers create the biological context for your study, turning a clinical question into a measurable answer. This article outlines how to use Ardena’s new Biomarker Catalogue to streamline the path from marker selection to quotation.
Few decisions in a development programme carry as much weight per sample as the choice of biomarkers. The right combination demonstrates target engagement, profiles pharmacodynamic response, flags safety signals early and supports patient selection. An incomplete one costs time, samples and, sometimes, a study readout.
Yet the process of sourcing biomarker bioanalysis is often slow. Sponsors need to check whether a lab has experience with a specific biomarker, on which platform, in which matrix and for which species. This often results in an inefficient back and forth before you get a clear answer.
This is the gap that the Ardena Biomarker Catalogue closes: 228 biomarkers across 12 disease areas and three analytical platforms, searchable and shortlistable in one place. Below, Ardena’s bioanalytical team outlines the questions that shape a solid biomarker strategy, and how the catalogue helps execute it.
1. Start with the question, not the biomarker
A biomarker is only useful if it answers a decision your study has to make. Before listing analytes, it is worth defining the questions the study must answer:
- Mechanism: is the drug hitting its target and modulating the pathway?
- Response: how do levels change with dose and over time?
- Safety: are there early signs of off target effects or organ damage?
- Disease: does the marker reflect progression, severity or the patient subgroup you want to enrol?
A single biomarker rarely addresses all of this, which is why a combination is usually required.
2. Match the platform to the molecule
Different molecules call for different technologies. The catalogue covers three analytical platforms:
- Immunoassay or ligand binding for proteins such as cytokines, chemokines, growth factors and neurodegeneration markers, from IL-6 and TNF-α to NfL, GFAP and pTau217.
- LC-MS/MS for small molecules and lipids Eg: amino acids, steroid hormones such as cortisol and estradiol, and sphingolipids such as glucosylsphingosine and ceramide panels.
- Flow cytometry for cellular profiling Eg: TBNK+ (T, B, NK cells and monocytes) and Treg panels.
Some biomarkers, have been analysed on both immunoassay and LC-MS/MS. This allows the analytical approach to be selected according to the required sensitivity, the matrix and the stage of development.
3. Think in biomarkers across disease areas
Biomarkers rarely respect therapeutic boundaries. IL-6 is relevant in immunology, cardiovascular, respiratory, metabolic and pain studies alike. For this reason, the catalogue is disease-agnostic: markers can be filtered by area, and each one is tagged with every area where it applies. Examples of biomarker combinations include:
| Study focus | Example biomarkers in the catalogue |
| Neurodegeneration | NfL, GFAP, pTau217, Tau, pNFH, BDNF |
| Parkinson’s disease and lysosomal storage disorders | GCase activity, glucosylsphingosine, LRRK2, GPNMB, lysosphingolipids |
| Type 2 inflammation, allergy and asthma | IL-4, IL-5, IL-13, IL-31, TSLP, IgE, periostin, TARC |
| Kidney safety | KIM-1, NGAL, NAG, alpha-GST, IL-18 |
| Heart failure and coagulation | NT-proBNP, ST2, D-dimer, P-selectin, TAT |
| Pulmonary fibrosis | KL-6, SP-D, MMP-7, CCL18, YKL-40 |
| Immune cell profiling | TBNK+ panel, T-regs panel |
4. Define your study context early
The same biomarker can need a different set-up depending on where and how it is measured. Principal of which is the study-specific context-of-use. This is driven by:
- 1. Stage of development
- 2. Intended purpose
- 3. Decision risk
- 4. Sample matrix, species and numbers
Understanding these factors early reduces iterations and results in a quote that reflects the actual study design.
From shortlist to quote: a worked example
Consider a study that requires kidney safety monitoring. In the Biomarker Catalogue, building your request takes four easy steps.
- Search or filter. Enter your candidate biomarker in the search bar (for example KIM-1) in the search bar, or filter by the nephrology disease area to view the kidney markers side by side, including NGAL, NAG, alpha-GST and IL-18. Searches by alias are also supported, so each marker can be found under its commonly used names.
- Check the platform. Each result shows the platform on which the marker runs, making it clear whether your selection has been run on a single technology or spans several.
- Build the shortlist. Tick the markers that address the study question.
- Request a quote. Provide the study details: study phase, species, matrix (for example urine, serum or plasma) and number of samples.
An Ardena bioanalytical scientist then reviews your request and replies within one business day with tailored quote factoring in the necessary steps to have the selected biomarkers ready for your study.
Can’t find your biomarker?
The catalogue reflects the current assay portfolio, not the limit of Ardena’s capabilities. For markers not yet listed, Ardena’s scientists can assess how to set up a suitable method.
Ready to build your biomarker plan? Explore the Biomarker Catalogue or write to us at contact@ardena.com.