Table 3:

Selected liquid biopsy tests within the FDA's Breakthrough Devices Program.

Kit/test	Company	Technology/application	FDA Status
Foundation One Liquid test	Roche Foundation Medicine	NGS test to detect clinically relevant indels, substitutions, CNV and selected genetic rearrangements in 70 oncogenes for companion diagnostic	FDA granted Breakthrough Device Designation (April 2018)
Multicancer early detection test	Grail	NGS blood test analyzing ctDNA methylation patterns for detecting multiple cancer types	FDA granted Breakthrough Device Designation (May 2019)
Guardant 360	Guardant Health	ctDNA test of mutations (73 genes), amplifications (18 genes), fusions (6 genes), indels (23 genes), to guide treatment selection in non-small-cell lung carcinoma	FDA granted Breakthrough Device Designation (May 2019)
Resolution HRD	Resolution Bioscience	NGS assay to detect sequence variations in genes associated with homologous recombination deficiency (HRD). Companion diagnostic for prostate cancer	FDA granted Breakthrough Device Designation (May 2019)
Cancer SEEK	Thrive Earlier Detection	Multianalyte test that combines multiplexed PCR detection of mutations in ctDNA at 1,933 loci with measurements of validated protein biomarkers to diagnose eight common cancer types	FDA granted Breakthrough Device Designation (May 2019)
ExoDx Prostate IntelliScore (EPI) test	Bio-Techne	Urine exosome-based genomic test for the diagnosis of prostate cancer	FDA granted Breakthrough Device Designation (June 2019)
Ivy Gene CORE Test; IvyGene DX Liver Test	Laboratory for Advanced Medicine (LAM)	Hyper-methylated ctDNA from multiple gene targets. To confirm the presence of breast, colon, liver, and lung cancers as early as stage 1	FDA granted Breakthrough Device Designation (September 2019)
[88], [89], [90]