Diagnostic Quality Assurance Pilot and Related Initiatives
Precision Medicine and Diagnostics
Advancing new approaches to molecular diagnostic quality assurance
The Diagnostic Quality Assurance Pilot addressed a standardization gap in personalized medicine by creating a process to compare diagnostics for targeted therapies in cancer treatment. The pilot, which was completed in the spring of 2019, worked to ensure that diagnostics provide clinicians with consistent and correct answers regardless of which laboratory conducted the test and which diagnostic platform the laboratory used. Specifically, the pilot designed and equipped molecular pathology laboratories with traceable reference samples and developed an evaluation approach to assess whether participating laboratories’ validated tests could achieve diagnostic performance comparable to an FDA-approved companion diagnostic for a targeted cancer therapy.
The pilot’s results were published in the American Journal of Clinical Pathology in December 2021. Tapestry Networks worked closely with the pilot’s multistakeholder steering committee, which included payers, industry, leading cancer non-profit organizations such as Friends of Cancer Research, and observers from government agencies, to support its implementation and opine on its results. The pilot’s results have prompted broad discussion across the diagnostics community.
The Pilot’s work sparked follow-on efforts to consider tools, approaches, frameworks, and new approaches for multistakeholder collaboration to effectively balance quality and access in use of diagnostic technologies in clinical trials and patient care in the precision medicine era. These include Tapestry’s leadership facilitating a working group on in silico reference files and the Local Test/ing in Clinical Trials Working Group.
