Biomarkers that reveal response or non-response to a particular drug are at the center of the personalized medicine movement. They are also becoming a growing requirement in clinical trials to allow for better patient stratification and outcome. For a company developing a therapy, having a biomarker strategy has become a necessity.
At Caprion, we assist in all aspects related to biomarker research: from discovering a new biomarker, to the development and support of its clinical use. We define ourselves as a partner of choice in the sphere of biomarker quantification with our diversified set of assays – immune or cell-based.
Our team of scientists has years of experience developing mass spectrometry (MS) workflows as well as customizing immunoassays and flow cytometry panels to specific clinical needs. Through our merger with HistoGeneX, we offer a full suite of histopathology and molecular pathology services also tailored to clinical standards.
When assessing immunotherapies by immune monitoring, it often requires the enumeration of cell populations which would be considered a biomarker of interest. Our multiparametric flow cytometry platform allows for the sensitive and precise cell enumeration of various population such as TBNK, while reducing sample processing time.
Specific populations can be defined with flow cytometry using cell surface or intra-cellular markers and followed through the course of a study. One example of such pharmacodynamic (PD) biomarkers is myeloid-derived suppressor cells (MDSC) which are used in the field of immunotherapies to perform patient stratification and assess response to treatment.
As highly quantitative assays, Enzyme-Linked Immunosorbent Spot (ELISpot) and FluoroSpot provide critical information on cellular immune-related activities and have become useful biomarker assays to monitor therapeutic immune modulation.
Our team has extensive experience in customizing and validating these assays to specific antigens. These include a fit-for-purpose ELISpot assay for the detection of IFNγ and a validated FluoroSpot assay for the identification of IFNγ and/or IL-4 producing cells.
Immunoassays are used to measure the presence and/or concentration of analytes (protein, hormone, antibody) with high specificity, even if the analyte of interest is in low concentration. Monitoring changes in patterns of analytes with immunoassays can lead to the discovery of new biomarkers. Once identified, these can be quantified using different immunoassays such as ELISA, MSD®, and LUMINEX®. With the advantage of being high throughput, multiplexed, and often requiring only a small volume of sample, immunoassays with valuable clinical samples can be performed with ease.
Identification and monitoring of biomarkers is also feasible using high-content cytometric analysis obtained from mass cytometry assays. As per flow cytometry, the technology can be used to define specific cell population with numerous surface markers.
Our mass cytometry platform can analyze up to 40 markers and can confidently be used to investigate clinical samples. We are leading the way in mass cytometry by providing services in a GCLP environment. Our team also offers assistance in data interpretation with advanced visualizations generated with our in-house software CellEngineTM.
Identifying new biomarkers in tissue samples and monitoring their presence following treatment is at the core of what our board-certified pathologists do. Patient stratification biomarkers such as ALK, EGFR, HER2, and BRAF are now commonly used as companion diagnostic assays.
At Caprion, we harness the power of multiplex immunohistochemistry (mIHC) to monitor these biomarkers under regulatory standards. With proficiency in multiple staining platforms such as immunofluorescence and in situ hybridisation, our team can also support biomarker discovery research in tissue samples.
DNA mutations, RNA fusions, DNA methylation patterns, and microsatellite instabilities may all represent clinically relevant biomarkers. Our team has the expertise to first properly extract the DNA and RNA of clinical samples, and perform standardized molecular analysis using the latest technology.
Given our expertise with mass spectrometry (MS), our services expand from biomarker discovery to multiplexed relative quantification and absolute quantification of biomarkers. Approaches such as liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) and Multiple Reaction Monitoring (MRM) are both fit for clinical applications and regulatory submission.
In collaboration with various partners, we brought numerous biomarkers to the markets, as development tools and clinical diagnostic tests.
Our off-the-shelf panels can be customized to measure clinically relevant biomarkers in FFPE samples. Highly quantitative assays measuring the expression of validated targets in other sample types, including soluble B-cell maturation antigen (BCMA) in plasma, are also readily available.