Assay accuracy and reproducibility are critical to the drug or device product development process.

 
 

We utilize a comprehensive range of technologies and methods applicable to both clinical trial and diagnostic testing to meet your targeted assay requirements. 

 

Challenge us. 

Our research team is fast, flexible, and experienced. Once we get to know you and your product, we assemble a customized team of Ph. D., MD, and laboratory technicians that specialize in your needs. We become an extension of your environment. Check out our full range of technologies. 

Cambridge Biomedical is CLIA certified, CAP accredited, and GLP compliant. We offer consulting services to help you navigate quality and regulatory requirements from pre-clinical to phase IV. Our skilled Quality Assurance team will ensure the integrity of your data at every step of the way. 

 

Assay Development Capabilities

Our team has experience with de novo assay development, technology transfer, optimization, and validation of novel or commercially available kits. We work with biological matrices from humans or animals, as well as both small and large molecules. 

Assays validated with our lab include a validation report customized to your exact requirements. The report includes the method of validation as well as detailed data supporting the validation parameters.

 

Validation Parameters:

 
 
  • Accuracy
  • Intra and inter-assay precision
  • Short-term stability at RT and 4°C
  • Long-term stability at -80°C
  • Linearity and dilution
  • Specificity and sensitivity
  • Interference
  • Reportable ranges and clinical reference ranges
 

 

Need more detail or have a technical question?

With Cambridge Biomedical, you are only a phone call or email away from an expert in your field.