Liquid biopsy technologies have made substantial headway in recent years, sparking booming commercial interest in the development of potential clinical applications. Some industry analysts expect the global market for these assays to grow to billion by 2025, a 38% increase over this year.1
FDA-approved liquid biopsies using circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) have been available for several years,2,3
but they have not been widely adopted into clinical practice, with the exception perhaps of lung cancer diagnostics.4,5
Advancements in the field are now allowing test developers to fine-tune the technology and overcome several of the initial hurdles. The field is exploding with competing technologies vying for the ultimate goal of establishing clinical utility.5
Among the potential data about tumors that liquid biopsies could offer, information on detecting cancer at an earlier stage is the most alluring, particularly in tumor types for which no effective screening tests are currently available. In 2016, the FDA approved the first liquid biopsy for cancer screening, Epigenomics’ Epi proColon.6,7
This year, several other liquid biopsy platforms received breakthrough device designations from the FDA,8,9
suggesting that others may soon join Epi proColon in this niche.
As liquid biopsy options grow, so, too, will the complexity of what these tests measure. The evolving field presents a diagnostic language that goes beyond the information yielded through tissue biopsy.
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