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 and originated from the Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) Working Group, 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.  

In late 2022, Tapestry Networks and a select group of stakeholders convened an informal working group to advance further exploration of the pilot’s dry lab or in silico component. In silico reference files (ISRFs) are economical materials that laboratories and test developers can use to assess bioinformatics pipeline performance to support next-generation-sequencing test development, validation, and quality assurance. In 2023, the effort explored potential use of ISRFs during clinical trials in cases where trials employ multiple clinical trial assays to enroll patients. Tapestry and partners continue to assess opportunities for better understanding ISRF use and their value in molecular diagnostic quality assurance.

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