Biomarker assays, standardized for analysis
Biomarker assays are increasingly crucial to clinical research and biologics testing, serving as surrogate or pharmacodynamic markers of efficacy. Xbiom™ brings the variety of specialty assays into standard notation, so omics, immuno-assays and more are ready for analysis and submission.
A preliminary read on a drug’s effectiveness
A specific biomarker assay can give an early indication of how well a drug works. That knowledge helps optimize clinical development programmes and reduce attrition, easing the pressures of development deadlines and resources.
Surrogate and PD markers
Biomarker assays act as surrogate or pharmacodynamic markers for monitoring clinical efficacy, helping identify a lead candidate and understand a medicine’s mechanism of action.
Earlier signals, shorter follow-up
By detecting intermediate success endpoints, biomarker assays help shorten follow-up times and surface a preliminary indication of effectiveness sooner.
Optimized development
A preliminary indication of effectiveness lessens the pressures of development deadlines and resources, optimizing clinical development programmes.
Fewer late-stage surprises
Acting on biomarker signals early reduces attrition rates, so resources concentrate on the candidates most likely to succeed.
Omics, immuno-assays and specialty assays
A variety of specialty assays complement the usual lab pathology done on clinical and nonclinical studies that support immuno-therapies or gene therapies.
Omics
Genomics, transcriptomics, proteomics and metabolomics data, managed through Xbiom ontologies.
Immuno-Assays
Quantitative immunoassays such as ELISA and multiplex panels for soluble analytes.
Anti-Drug Antibody
Immunogenicity testing for anti-drug antibody detection and titer in biologics programmes.
FACS
Flow cytometry for cell population phenotyping and immune monitoring.
IHC
Immunohistochemistry for tissue-based marker expression and scoring.
Bio-Analytics & Specialty
Bio-analytical and specialty assays that support immuno-therapies and gene therapies.
From specialty assay to standard notation
Xbiom™ maintains awareness of standards held in globally accepted registries and provides automated transformations of biomarker assay data into standard notation.
Complement lab pathology
Specialty assays sit alongside the usual lab pathology on clinical and nonclinical studies supporting immuno-therapies and gene therapies.
Stay registry-aware
Xbiom™ tracks the standards maintained in globally accepted registries, keeping assay notation aligned with accepted conventions.
Transform automatically
Biomarker assay data is transformed automatically into standard notation, with omics categories managed in Xbiom ontologies.
Omics categories managed in Xbiom
Examples of the omics categories managed in Xbiom ontologies.
| OMICS | Measurement | Measurement Types | Methods | Vendor | Dictionaries | Biomarker Counts |
|---|---|---|---|---|---|---|
| Genomics | Genetic Variation | Short Variant | DNA Targeted Sequencing, Digital PCR, Measurable Residual Disease | Foundation Medicines; Sysmex Inostics; Applied Biosystems; Adaptive Biotechnologies | NCBI Gene, HUGO Gene, COSMIC, dbSNP | 59,670Genes |
| Copy Number Alteration | ||||||
| Rearrangements | ||||||
| MRD | ||||||
| Transcriptomics | Sequencing | Targeted RNA Sequencing | Targeted RNA Sequencing | Illumina | NCBI Gene Info | |
| Expression | Gene Expression; Targeted mRNA expression | Microarray, Nanostring | AltheaDx; Nanostring Technologies | |||
| Targeted mRNA expression | In situ Hybridization | Targos | ||||
| miRNA expression | qRT-PCR | Covance | miRBase | 2,656miRNA | ||
| Proteomics | Expression | Expression of Proteins | Immunohistochemistry | Mosaic Laboratories, NeoGenomics | UniProt (SwissProt) | 20,500*Proteins*Including immuno biomarkers: cytokines, chemokines, cell receptors. |
| Concentration | Concentration of Proteins | Immunoassay, ELISA, Multiplex Assay | Myriad RBM | |||
| Expression | Cell Sorting (isolate cells expressing fluorescent proteins for protein expression); Cell Quantification based on specific surface proteins | Flow Cytometry, CTC profiling | Laboratory for clinical research GmbH; FCSL; Epic Sciences | |||
| Metabolomics | Concentration | Concentration of Metabolites | Liquid Chromatography-Mass Spectrometry | BIOCRATES Life Sciences AG | Human Metabolome Database (HMDB) | 114,100Metabolites |
| Immunology | Immune Response | Cellular Immune Response; Anti-Drug Antibodies | ELISA, ECL, Immunoassay | CHIMERA | ||
| Immunophenotyping; Cell Function | Flow Cytometry | Flow Contract Site Laboratory, LLC | Human Cell Markers; Cell Ontology | Cell Surface Antigens |
Biomarker assays, answered
What are biomarker assays used for?+
How do biomarker assays reduce development risk?+
Which assay types does Xbiom support?+
How does Xbiom standardize biomarker assay data?+
Bring your specialty assays into standard notation
Standardize omics, immuno-assays, ADA, FACS, IHC and bio-analytics with Xbiom™ ontologies and automated transformations. See how biomarker assay data becomes analysis-ready and submission-ready.
