Liquid Biopsies in Oncology and the Current Regulatory Landscape.
There is a profound need in oncology to detect cancer earlier, guide individualized therapies, and better monitor progress during treatment. Currently, some of this information can be achieved through solid tissue biopsy and imaging. However, these techniques are limited because of the invasiveness of the procedure and the size of the tumor. A liquid biopsy can overcome these barriers as its non-invasive nature allows samples to be collected over time. Liquid biopsies may also allow earlier detection than traditional imaging. Liquid biopsies include the analysis of circulating tumor cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles obtained from a variety of biofluids, such as peripheral blood. In this review, we discuss different liquid biopsy types and how they fit into the current regulatory landscape.
Department of Pathology and Laboratory Medicine, School of Medicine, University of Louisville, 511 South Floyd Street, MDR 221, Louisville, KY, 40202, USA.|PGXL Technologies, 201 E. Floyd St., Suite 306, Louisville, KY, USA.
Lindsay N
LN
Strotman
Department of Pathology and Laboratory Medicine, School of Medicine, University of Louisville, 511 South Floyd Street, MDR 221, Louisville, KY, 40202, USA.|PGXL Technologies, 201 E. Floyd St., Suite 306, Louisville, KY, USA.
Lori M
LM
Millner
Department of Pathology and Laboratory Medicine, School of Medicine, University of Louisville, 511 South Floyd Street, MDR 221, Louisville, KY, 40202, USA.|PGXL Technologies, 201 E. Floyd St., Suite 306, Louisville, KY, USA.
Roland
R
Valdes
Department of Pathology and Laboratory Medicine, School of Medicine, University of Louisville, 511 South Floyd Street, MDR 221, Louisville, KY, 40202, USA. mark.linder@louisville.edu.|PGXL Technologies, 201 E. Floyd St., Suite 306, Louisville, KY, USA. mark.linder@louisville.edu.
Mark W
MW
Linder
D014408:Biomarkers, Tumor; D001706:Biopsy / Q000379:methods*; D004273:DNA, Neoplasm / Q000097:blood / Q000235:genetics*; D019468:Disease Management; D000067128:Extracellular Vesicles; D033161:Government Regulation; D006801:Humans; D009369:Neoplasms / Q000097:blood* / Q000175:diagnosis*; D009360:Neoplastic Cells, Circulating / Q000378:metabolism* / Q000473:pathology; D017410:Practice Guidelines as Topic
D014408:Biomarkers, Tumor; D004273:DNA, Neoplasm