NEW YORK (GenomeWeb) – As liquid biopsy genetic tests have rocketed into clinical practice over the last handful of years, clinical researchers, test developers, and others have begun to pay increasing attention to a relative lack of tools to ensure assays are validated and performed according to common, or at least equivalent standards.
Last fall, for example, saw the launch of a consortium called the Blood Profiling Atlas in Cancer (BloodPAC) under the White House’s Cancer Moonshot Initiative, aimed at aggregating and harmonizing data on current liquid biopsy tests, and on standardizing protocols for sample collection, preparation, and analysis for future test development.
“While many blood proﬁling platforms exist for research use only (RUO), questions remain regarding the performance characteristics and clinical validation of these platforms, and standard protocols for sample collection, processing, and analysis remain to be established. This information is a prerequisite to the design of clinical studies to demonstrate clinical utility … assay reproducibility, and provide support for [US Food and Drug Administration] approval and payer reimbursement,” authors wrote in a paper describing BloodPAC this spring.
In parallel to BloodPAC (and to other efforts by academic groups), companies have also begun to highlight new products this year,