Arizona BioSignatures Laboratory (ABL)

Biomarkers and biosignatures can provide more accurate diagnosis and greater understanding of human diseases. They can enable personalized medicine and they can accelerate the safe testing of new medical products. The U.S. Food and Drug Administration (FDA) encourages the use of biomarkers and biosignatures to improve medical product development. However, biosignatures are often measured inconsistently, making it difficult to assess their value in clinical trials. The lack of assay standards for emerging biosignatures represents a major impediment to their incorporation in drug development research and clinical investigations.

Critical Path Institute (C-Path) received funding from Science Foundation Arizona to explore the feasibility of creating a laboratory to address this problem. As a result, the Arizona BioSignatures Laboratory (ABL) was incorporated in January 2009 as a non-profit, wholly-owned subsidiary of C-Path. ABL's mission is to establish assay standards for emerging biomarkers and biosignatures. ABL serves as a resource for government agencies and for the research community that uses emerging biosignatures to support medical product research and development.

To achieve its goals, ABL:

• Consults researchers in academia, industry, and government to identify emerging biosignatures and assays;
• Evaluates, writes, and disseminates Standard Operating Procedures (SOPs) for 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 biosignature discovery and translation;
• Works with collaborators to establish analytic, performance, and biomaterial standards for emerging biomarkers and biosignatures; and
• Assists C-Path in seeking biosignature qualification by the FDA for use in medical product development.