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 a 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.
A subset of the Sustainable Predictive Oncology Therapeutics and Diagnostics working group designed the 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.
In 2022, a small group of stakeholders working to advance diagnostic quality, together with Tapestry Networks, held a series of discussions to inform and help launch an exploratory working group that will consider how to expand the use of in-silico reference files to advance and optimize the quality of biomarker-based diagnostics and treatments.
In-Silico Reference File Working Group Summary of Themes - October 2022
Diagnostic Quality Assurance Pilot - technical paper: "Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics" - December 2021, AJCP
AJCP Editorial on "Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics" - December 2021
Diagnostic Quality Assurance Pilot - white paper: “Implications of performance variation in next generation sequencing-based laboratory developed tests for oncology: Stakeholder views" - December 2021
Molecular Diagnostic Quality Assurance Summit Summary of Themes - March 2021
Presentation by Barbara Zehnbauer, Steering Committee Chair, at the American Association for Cancer Research Annual Meeting, April 2019