Diagnostic Quality Assurance Pilot & Related Initiatives

Committed stakeholders pilot a new approach 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' appropriately 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 regulators, payers, industry, the American Society of Clinical Oncology, Friends of Cancer Research, and others to support its implementation. A white paper discussing select steering committee member and liaison opinions about the pilot and its results can be found below.

In late 2022, Tapestry Networks and a select group of stakeholders convened a 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. This effort will first focus on potential use of ISRFs during clinical trials in cases where trials employ multiple clinical trial assays to enroll patients. Recent publications from the in silico work are below.

Project background:

A subset of the Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) working group designed the Diagnostic Quality Assurance pilot in 2015 and launched it in March 2016. More details on the pilot’s concept were previously published in 2017 in the Journal of Molecular Diagnostics. The SPOT/Dx working group aimed to address various opportunities and challenges relating to the advent of the precision medicine era in the United States, with a focus on oncology and diagnostic development and quality assurance.

Relevant publications: