Publication

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 lab conducts the test and which diagnostic platform the lab uses. To achieve this goal, the pilot will design and equip molecular pathology labs with traceable reference samples to assess whether participating labs’ appropriately validated tests can achieve diagnostic performance comparable to a companion diagnostic (CDx) for targeted cancer therapy. These reference samples are intended to complement internal quality controls that should already be used by labs to gauge the accuracy of each assay run, or lot, as is routinely done in clinical chemistry.