The availability of biomarkers can greatly facilitate the interpretation of clinical trial results, but the use of poorly validated assays to detect them has resulted in a profound lack of useful biomarkers. The biomarker pipeline was recently described as “plagued by problems” and “too prone to failures”. This could be due to the lack of a robust biological connection between the molecular marker and the disease-specific molecular dysfunction, or due to the absence of a rigorous clinical validation.
We develop and validate biomarker assays according to FDA/EMA guidelines in order to minimize the technical variability and ensure maximal reproducibility. To ensure that we include a wide variety of biomarker molecules, we employ different technologies for detection i.e.:
- Mass spectrometry for high sensitive metabolite detection
- NMR for metabolite profiling as a biomarker technique
- Immunoassays for protein and biologics detection (including anti-drug antibodies)
One of our strengths is the development and validation of assays for the detection of low-abundancy protein biomarkers. We have developed immunoassays by using ultrasensitive platforms like SMC (formerly Singulex, now SMCxPRO), Quanterix and MesoScale Discovery. In addition, we have experience in running several aspects of an assay to GCP/GLP compliance.
- Production, qualification and handing of in-house produced reagents (e.g. standard proteins and derivatized antibodies)
- Fully electronic traceability of samples and data analysis
- SOP regulated environment
We carry out the following tests according to validation guidelines, which are then provided in the form of a validation report:
- Performance of the standard curve
- Accuracy and precision
- Spike recovery
- Selectivity and specificity
The generation and validation of a biomarker assay early on during the development of a pharmaceutical product has proven to be instrumental in the reduction of the attrition rate. Biomarkers increase the chances of the compound being successful right up to and through Phase Two. Thus, we understand the critical importance of developing robust biomarkers that provide meaningful readouts.