Author: Mark Dresser, PhD on August 21, 2019
Historically, cancer detection and drug response monitoring required collecting tumor biopsies, which can be a very invasive procedure, to characterize many types of solid tumors such as non-small cell lung cancer (NSCLC), and is practically infeasible for many others. Furthermore, given their invasive nature, tumor biopsy assessments are often limited to single pre- and post-treatment biopsies in clinical trials with investigational therapies, significantly limiting the elucidation of tumor heterogeneity and the longitudinal assessment of drug treatment response. In contrast, liquid biopsies involve the measurement of circulating tumor cells or cell products from a range of bodily fluids (e.g., blood, urine) and is therefore a much less invasive procedure.
Although notable progress has been made in the research and development of liquid biopsy tests, thus far only two such tests have overcome the scientific, technical, and regulatory hurdles to garner approval by the US Food and Drug Administration (FDA). The first test was approved in 2016 for the detection of EGFR mutations in NSCLC patients (1). The second test was just approved this year for the detection of the PIK3CA mutation in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (2). In a recent review published in Clinical and Translational Science (CTS) entitled The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics, Dr. Federico Goodsaid provides a comprehensive review focusing on both product development and regulatory approval considerations for liquid biopsy diagnostics. It covers many helpful and practical topics such as relevant FDA guidances, test design considerations, test performance characteristics, and test run metics. The review also addresses circulating tumor cell platform technology development and concludes with a summary of the regulatory path for liquid biopsy diagnostic approvals, including elements for liquid biopsy regulatory submissions.
This review will serve as an excellent resource to researchers, clinicians, and regulators interested in the product development and regulatory approval of liquid biopsy tests. The CTS Editorial Team would like to thank Dr. Goodsaid for his excellent contribution to the journal. We welcome the submission of original research articles on this topic.
Image by Goodsaid. Clin. Trans. Sci., https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12657, is licensed under CC BY-NC 4.0. ©2019 The Author.
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