Addressing lessons from the Diagnostic Quality Assurance Pilot

March 2021

In 2013, the Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) working group committed to developing a new approach to assess laboratory test validation and performance. Consequently, the Diagnostic Quality Assurance Pilot was launched in 2016 with the aim of ensuring that oncologists could confidently select appropriate targeted therapies for treatment, regardless of which molecular diagnostic test was used to inform their recommendation.1 A multistakeholder steering committee—which included representatives from the American Society of Clinical Oncology, the College of American Pathologists, Friends of Cancer Research, public and private payers (including Palmetto GBA, Blue Cross Blue Shield Association, and others), industry representatives from Amgen and Illumina, and observers from the National Cancer Institute, US Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services—helped inform the pilot’s efforts. The Scientific and Technical Working Group, overseen by the College of American Pathologists and comprising leading molecular pathology experts, supported the pilot’s technical design and execution. Steering committee and working group leadership convened in December 2020 with alumni from the original SPOT/Dx working group and other stakeholders for a summit to discuss the pilot’s results and implications.

Over the course of implementation, the pilot provided clinical laboratories with engineered wet-lab reference samples, in-silico sequence data file samples, and digital images of tissue section slides, and it developed an evaluation methodology to assess the analytical performance of validated laboratory-developed tests (LDTs) relative to an FDA-approved companion diagnostic (CDx) for a targeted cancer therapy. During the summit, pilot leadership and others contended that well-defined reference samples and in-silico files could offer an enhanced quality assurance (QA) approach that could complement existing processes such as proficiency testing.2 Many participants agreed there is value in understanding how performance compares across laboratories. Some stakeholders, however, emphasized the complexities and limitations of the pilot’s approach. That said, even the pilot’s skeptics recognized its value as a starting point to improve understanding about laboratory test validation and QA as large-scale, complex next-generation sequencing (NGS) panels become more prevalent.