Table 2:

Liquid biopsy FDA-approved tests.

Kit/test	Company	FDA Status	Alteration detected /technology	Application	Other information
T Cell Search Circulating Tumor Cell Kit [15]	Menarini Silicon Biosystems	FDA-approved (August 2013)	Enumeration of circulating tumor cells (CTC) of epithelial origin: EpCAM positive enrichment and detection of cytokeratins 8, 18, and/or 19.	Prognosis of metastatic breast, colorectal, or prostate cancer	The sensitivity of this kit will depend on the positivity of CTCs for EpCAM surface marker as well as cytokeratins 8, 18, and/or 19.
Epi proColon DNA-methylation blood test [82]	Epigenomics AG	FDA-approved (April 2016)	Detection of methylated cytosine residues in the SEPTIN9 gene in ctDNA by real-time PCR	Screening for colon cancer	The company has developed a kit to assess SEPTIN9 methylation that will be completed in around 32 h. According to the literature, its sensitivity ranges from 69-72%.
Cobas EGFR Mutation Test v2 [16]	Roche Diagnostics	FDA-approved (June 2016)	Detection of 42 defined mutations in the epidermal growth factor receptor (EGFR) gene by real-time PCR	Guiding treatment selection in non-small-cell lung carcinoma	This test allows for detection of mutations in cfDNA in less than 4 h (12). 75% of sensitivity and 98% of specificity.
ClonoSEQ [83]	Adaptiv Biotechnologies	FDA-approved (Septembre 2018)	Detection of immunoglobulin receptor gene sequences and frequently translocated regions by multiplex PCR and next-generation sequencing (NGS).	Detection of minimal residual disease in acute lymphoblastic leukemia or multiple myeloma	ClonoSeq detects a single cancer cell among a million cells. Data processing will take between 7 and 14 days.