Committed stakeholders chart a course for molecular diagnostic quality assurance
The Diagnostic Quality Assurance Pilot addresses a standardization gap in personalized medicine by creating a process to compare diagnostics for targeted therapies in cancer treatment. The pilot helps to ensure that diagnostics provide clinicians with consistent and correct answers, regardless of which laboratory conducts the test and which diagnostic platform the laboratory uses. To achieve this goal, the pilot will design and equip molecular pathology laboratories with traceable reference samples and develop an evaluation approach to assess whether participating laboratories' appropriately validated tests can achieve diagnostic performance comparable to a companion diagnostic for targeted cancer therapy.
The pilot was completed in the spring of 2019 and will share results with the community in late 2020 and early 2021. Tapestry Networks has worked closely with the pilot’s multistakeholder steering committee, which includes regulators, payers, industry, the American Society of Clinical Oncology, the College of American Pathologists, Friends of Cancer Research, and others to support its implementation and will help share its outcomes.
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 have been published in the Journal of Molecular Diagnostics.