A model to demonstrate comparative laboratory test performance with an oncology companion diagnostic assay

January 2017

*Originally published in the Journal of Molecular Diagnostics – January 2017

Formal evaluation of interlaboratory equivalence of clinical molecular laboratory testing has been hampered by the relative absence of suitable reference materials. Furthermore, the validation of laboratory tests in individual laboratories may not itself result in equivalent diagnostic test results. Development of technically sound strategies for demonstrating test equivalence is urgently needed, particularly for rapidly changing and complex technologies, such as next-generation sequencing. One challenge for diagnostic laboratories is demonstration of laboratory-developed testing (LDT) methods as equivalent to Food and Drug Administration (FDA) cleared or approved assays, especially for companion diagnostic testing for oncology therapies.

To address these needs for reference materials to achieve test standardization, a multi-stakeholder initiative, the Diagnostic Quality Assurance Pilot, has been launched to design, develop, test, and evaluate traceable reference sample materials (referred to in the pilot as reference samples) to provide molecular pathology laboratories with the means to demonstrate equivalent performance of LDTs comparable to a selected CDx for targeted cancer therapy.