It is our belief that C-Path's EGFR project would...standardize the way studies of diagnostics for targeted therapies are performed in preparation for submissions for approval.

-Steven Gutman, MD, former Director of the Office of In Vitro Diagnostics, US Food and Drug Administration

 

Arizona Biosignatures Alliance

The Arizona Biosignatures Alliance is a collaboration between the International Genomics Consortium (IGC), Critical Path Institute (C-Path), and Arizona State University (ASU) formed to bring precision and robustness to diagnostics used in clinical trials and patient testing at hospitals and laboratories around the world. These three cutting-edge organizations have joined forces in order to maximize expertise in the area of diagnostic testing and standardization. The Arizona Biosignatures Alliance will validate assays for biomarkers for the bioscience industry.

Program Initiatives:

  • Assay standardization and development
    • Make existing assays reproducible, standardized, and ready for widespread dissemination
    • Experience with a wide array of platforms and technologies, including those most commonly used in clinical laboratories
  • Data to support regulatory filings
  • Facilitation of partnerships
    • Experience developing precompetitive collaborations

Setting the Standard for Biomarker Testing

As personalized medicine based on an individual's biology continues to deliver improved therapies to combat diseases, standardizing diagnostic tests prior to their use in clinical settings is critical. The complexity of new genomic predictive tests increases the importance of accurate, standardized tests that other scientists can replicate.

Setting quality standards for future diagnostics is of importance to ensure that patients have the best opportunity to get consistent test results in different locations of analysis. Uniform testing results will demonstrate which diagnostics prove to be the most predictive for diagnosis and treatment of disease.

To achieve its goals, the Arizona Biosignatures Alliance:

  • Consults researchers in academia, industry, and government to identify emerging biomarkers, biosignatures and assays;
  • Evaluates, writes, and disseminates Standard Operating Procedures (SOPs) for biomarker and biosignature assays;
  • Collects clinically-annotated biological samples and conducts analytical cross-validations;
  • Identifies and provides reagents and reference material standards for biosignature assay evaluation and calibration;
  • Works with researchers to facilitate their efforts in biomarker and biosignature discovery and translation;
  • Works with collaborators to establish analytic, performance, and biomaterial standards for emerging biomarkers and biosignatures; and
  • Establishes the analytic validity of assays, thereby assisting C-Path in seeking biomarker and biosignature qualification by the FDA for use in medical product development.