Assay Development and Validation

We specialize in creating and running tests to meet your specific biomarker testing needs, supported by a range of pre-designed or expertly designed custom assays. Our array of multi-omic platforms, with a diverse array of chemistry options, provides the flexibility needed to craft the optimal biomarker strategy for your project.

All assay verification and validation studies are performed under our Quality Management System (QMS) to ensure that your assay meets your testing needs, applications, and specific requirements.

We Can Design

  • Together we can collaborate to develop and qualify assays and perform sample testing
  • We have a focused and dedicated team that can manage your project

We Can Develop

  • We can design and develop your assay with appropriate controls and reference samples
  • We can develop an assay that meets your specificity, sensitivity, accuracy, and precision requirements

We Can Verify and Validate

  • We follow CAP/CLIA, NYS CLEP, and FDA/ICH guidelines for assay verification and validation
  • Our Quality Assurance team reviews all data, project plans and reports so you can be confident in your results

GENOMICS

DNA or RNA, we have the right technologies to properly and holistically scrutinize any molecular biomarker. Whether you’re interested in a single variant or multiple genes, we can develop a sensitive and specific assay that is both high throughput and capable of rapid turnaround time.

We leverage cutting-edge, ultra-sensitive technologies to deliver in-depth genomic diagnostic insights.

Genomics Page

PROTEOMICS

As a pioneering market leader, we boast over 15 years of expertise in clinical proteomics. Proteomics are a powerful tool for understanding and predicting a patient’s response to disease and therapy. Whether you’re interested in quantifying single peptides, assessing post-translational modifications, or identifying a more complex proteomic signature we have the required tools, expertise and certified partners.

We leverage sensitive and both targeted and non-targeted technologies to deliver in-depth proteomic insights.

Proteomics Page

ddPCR is a trademark of Bio-Rad Laboratories, Inc.
CAP: College of American Pathologists
CLIA: Clinical Laboratory Improvement Amendments
NYS CLEP: New York State Clinical Laboratory Evaluation Program
ICH: International Council for Harmonization