Ace Therapeutics has advanced knowledge and extensive hands-on experience in providing innovative analytical strategies for pharmaceutical and biotechnology companies. We are committed to providing biomarker validation services to test the sensitivity, specificity, and analytical validity of our clients' biomarker candidates.

Introduction of Psychiatric Biomarker Validation

Research on psychiatry-related biomarkers for major depression, schizophrenia, bipolar disorder, and other psychiatric disorders has intensified in recent years. Biomarkers in psychiatry have the potential to elucidate the etiology of ambiguous clinical presentations. Biomarkers that can be measured in a high-throughput, reproducible manner in preclinical models offer the potential to increase the speed and efficacy of drug development for antipsychotic disorders. Expanded research on biomarker development will contribute to better diagnosis and a deeper understanding of psychiatric disorders.

Fig. 1 Represents potential peripheral biomarkers of schizophrenia. (Abi-Dargham A, et al., 2016)

Biomarker Validation Services

Ace Therapeutics uses a systems biology approach to help our clients understand the biological mechanisms associated with psychiatric disorders to maximize the discovery of novel and relevant biomarkers. These biomarkers can be used to monitor disease progression, drug response, toxicology, and target engagement in models of psychiatric disorders. The translatability of preclinical biomarkers is enhanced when we test and validate them.

Our biomarker validation services can provide the following information for drug development:

• Advance your therapeutic candidates with genomic and proteomic analysis
• Effectively predict response and toxicity through potential candidate biomarker identification
• Enhance your pharmacology data by identifying qualitative and quantitative drug effects at the genomic and proteomic levels
• Integrate mechanism of action and PD to maximize efficacy
• Reduce potential toxicity by understanding the immunological and morphological composition of relevant organs
• Expand treatment efficacy through improved monitoring of disease progression and treatment durability

Analytical Validation

• Precision, the limit of detection and linearity
• Sensitivity, specificity, and predictive values
• According to ISO standards and CLSI guidelines
• For different assay platforms: single/multiplex, microarrays, mass-spectrometry, ELISA, RT-PCR, etc.

Tools

• Flow cytometry for cell function and phenotype analysis and biomarker expression
• ELISA-based cytokine and chemokine analysis
• Imaging-based rare cell analysis to track cells expressing reactive biomarkers
• Histology and digital pathology for biomarker detection and spatial expression
• Mass spectrometry-based proteomic analysis
• Genomic analysis

Our Advantages

• Collaboration, scientific design and problem-solving to meet your unique needs
• Deep expertise and insight to drive your preclinical (including exploratory biomarker programs)
• Innovative, state-of-the-art platforms and global laboratory testing capabilities

Ace Therapeutics uses systems biology and integrated platform approaches for biomarker discovery and validation, thus providing the best opportunity for early identification of the most promising biomarker candidates. Rely on our flexible approach, extensive experience, well-established and validated workflows, highly specialized bioinformatics team, an extensive collection of historical data, high quality and fast turnaround to support your preclinical drug development for psychiatric disorders. If you are interested in our services, please feel free to make an inquiry.

Reference

1. Abi-Dargham A, Horga G. The search for imaging biomarkers in psychiatric disorders. Nat Med. 2016, 22(11):1248-1255.