The lack of adequate circulating tumour DNA reference materials for developing and measuring safe, accurate, and reproducible assays continues to be a challenge for clinical labs.
Liquid biopsies are poised to revolutionise cancer diagnosis and therapy, but until now, advances in diagnostic technology, particularly at the low end of the sample input and sensitivity spectrum, have been hampered by the lack of ability of labs to reproducibly measure and assess the assay’s performance. There has been a dearth of sufficiently qualified reference materials to fully and properly develop, validate and monitor these liquid biopsy assays. As a result, many of the early adopters of these tests are the larger volume cancer centres with the patient volumes and resources to support and validate these innovative new assays. Even more labs, however, are interested in developing their own assays and leveraging the ability to potentially monitor recurrence and prognosis when the primary tumour is no longer available.
Competition between labs with different technologies and methods is resulting in many unsubstantiated performance claims with limited validation data made publically available for clinicians and patients to review. Even more challenging for the industry is reconciling inter-laboratory performance standards, an area that is begging for better options. If labs continue developing their own unique assays and methods, then one of the obvious solutions is the use of a universal standard or reference material calibrator to properly measure and assess performance similarities and differences.