Diagnostic Quality Assurance Pilot & Related Initiatives
Piloting a new approach to molecular diagnostic quality assurance
The Diagnostic Quality Assurance Pilot aimed to standardize diagnostics in personalized medicine for cancer treatment by ensuring consistent and accurate results across different laboratories and diagnostic platforms.
The Diagnostic Quality Assurance Pilot addressed a standardization gap in personalized medicine by creating a process to compare diagnostics for use in cancer treatment. The pilot, completed in 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. It equipped molecular pathology laboratories with traceable reference samples and developed an approach for assessing whether participating laboratories’ 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 a multistakeholder steering committee that included regulators, payers, industry, the American Society of Clinical Oncology, and Friends of Cancer Research, white paper discussing expert 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 further explore 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.
