Abstract:The evolution of chemistries and instrument platforms for next‐generation sequencing has led to sequencing of genomic variants in both tumor biopsies as well as in circulating tumor cells (CTCs) and cell‐free DNA liquid biopsies. The transition of these analytical platforms into clinical ones has led to challenges in product development as well as regulatory strategies for the approval of diagnostic products with these platforms. Regulatory strategies for liquid biopsy diagnostics depend on a framework that ha… Show more
“…Overall, the goals for in vitro diagnostic biomarker studies are that they should produce valid scientific evidence demonstrating reasonable assurance of the safety and effectiveness of the product and protect the rights and welfare of study subjects. ( 63,64 )…”
Section: Surveillance For Hcc: Design and Endpointsmentioning
“…Overall, the goals for in vitro diagnostic biomarker studies are that they should produce valid scientific evidence demonstrating reasonable assurance of the safety and effectiveness of the product and protect the rights and welfare of study subjects. ( 63,64 )…”
Section: Surveillance For Hcc: Design and Endpointsmentioning
“…Many biomarker panels have gone through such rigorous interrogations (eg, ColoGuard), which led to approvals by the US Food and Drug Administration for specific clinical applications. 8 In this issue of the Gastroenterology, Wada et al, 9 describe the process through which they developed a transcriptomic signature that consisted of both mRNA and microRNAs (miRNAs) for the identification of patients with T1 CRCs and presence of lymph nodes metastasis (LNM). This has potential eventual clinical application for helping to reduce overtreatment in those who are deemed to be lymph node negative.…”
Section: Blood-based Liquid Biopsies: a Noninvasive And Cost-effective Tool For Improved Risk Assessment And Identification Of Lymph Nodementioning
“…However, the pre-analytical variability of the liquids, the differences of the sequencing chemistries and the innate methodological characteristics of NGS (variable library preparation, different software of variant calling) make difficult to homogenize the procedures in different laboratories. On clinical grounds, there are still no shared guidelines, except for EGFR mutations in lung cancer, for the timing of sampling and the biomarkers that must be investigated in each tumor type [27]. Genito-urinary malignancies may benefit from the implementation of liquid biopsies based on urine samples.…”
Section: Strengths and Weaknesses Of Liquid Biopsymentioning
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