Biomarker Analysis and Assay
Ask us about validated, reliable biomarkers that can be used in your project. We can provide free analysis of markers appropriate for your pathway or set up quantitative assays for your marker of interest.
Analysis of biomarkers in biological samples can dramatically increase your chances of success in ANY drug development program including support for:
– Target identification
– Proof of mechanism
– Proof of concept
– Treatment/safety monitoring
– Outcome measurement
Biomarker analysis can be performed at every stage of drug R&D using serum, plasma, cerebrospinal fluid, urine, tissue culture supernatants, bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings. The samples are examined to analyze patterns of proteins that correlate with progression of disease or therapy (biomarkers). In addition, metabolic and toxicity indicators can be examined. Using this information, Alera Labs provides valuable guidance on the drug candidates that will be more likely to produce a positive response. Our assays can be used in any therapeutic area such as oncology, cardiovascular, inflammation, infectious disease, and most others.
Alera Labs provides customized biomarker assay development services to meet your needs for pre-clinical and clinical trials. We further validate the assay for its sensitivity, specificity, accuracy, reproducibility, and stability. Through assay validation studies, Alera Labs’ scientists can provide you with reliable and accurate results that are scientifically sound and meet FDA and other regulatory directives.
An assay validation study can help you make important decisions to protect the integrity of your trial. You can choose three levels of service that we provide to optimize and validate your assay:
– Proof-of-concept (POC) to verify the feasibility of reagents.
– Quantification to test the validity of biomarkers by using
– method-to-method comparing studies.
– Full-validation to validate assay through standard tests to be applicable, and to support GCP and GLP studies. The validation includes intra- and inter- precision, tech-to-tech comparison, sample stability, sample recovery, linearity etc.
Assay validation studies are focused on assay performance. The validated assay is to ensure that the tested biomarker is linked to a clinical significance to support your Investigative New Drug Application (INDA) and New Drug Application (NDA).