Table 1 Sensitivity for advanced adenomas reported in various assays of commercial and academic development

FIT [59]

Feces

Hemoglobin

Meta analysis of FITs vs colonoscopy for average-risk persons

(31 studies with 120,255 participants)

40%

(33%—47%)^A

FIT [66]

Feces

Hemoglobin

Meta analysis of screening studies for FIT’s sensitivity to adenomas

(10 studies with 63,473 participants)

27%

(23% – 31%)

Cologuard [67]

[Exact Sciences]

Feces

Hemoglobin + 

3 mutations of KRAS + 

10 mutations of APC + 

8 mutation of TP53

Cologuard (vs. Hemoccult II) in asymptomatic, average-risk adults aged 50 or older

(N = 2,507)

12.1%

(12.0% – 19.0%)

Cologuard [68]

[Exact Sciences]

Feces

Hemoglobin + 

7 mutations of KRAS + 

2 gene methylation status (NDGR4 and BMP3) + 

β‐Actin

Cologuard (vs. FIT) in asymptomatic, average-risk adults aged 50–84 years (N = 9,989)

42.4%

(38.9% – 46.0%)

Cologuard [69]

[Exact Sciences]

Feces

Hemoglobin + 

4 gene methylation status (LASS4, LRRC4, PPP2R5C, and ZDHHC1)

Cologuard (vs. FIT) in asymptomatic, average-risk adults aged 40 or older (N = 20,176)

43.4%

(41.3% – 45.6%)

ColoSense [70]

[Geneoscopy]

Feces

Hemoglobin + 

Smoking status + 

8 mRNA targets (ACY1, AREG, CDH1, EGLN2, GAPDH, KRAS, SMAD4, and TNFRSF10B)

ColoSense (vs. FIT) in asymptomatic, average-risk adults aged 45 or older; blinded, prospective, cross-sectional

(N = 8,920)

45.9%

(42% – 50%)

Epi proColon

[Epigenomics]

Colovantage

[Quest] [48, 71]

Blood

Septin-9 methylation status

Prospective study of adults aged 50 or older (N = 7,941)

11.2%

EarlyTect [72, 73]

[Genomic Tree]

Colosafe

[Creative Biosciences]

Feces

Gene methylation status of SCD2

Meta-analysis of blood Septin-9

(25 studies)

15%

(11% – 19%)

ColonAiQ [74]

[Singlera/Clinomics]

Blood

5 gene methylation status (Septin-9, BCAT1, IKZF1, BCAN, VAV3)

Retrospective case–control study

(N = 348)

42%

(33.1% – 51.5%)

Coloscape

[Diacarta] [75]

Blood

61 mutations in 8 genes (APC, KRAS, BRAF, TP53, CTNNB1, NRAS, SMAD4, and PIK3CA) + 

7 methylated markers

Retrospective case–control study

(N = NA) ^B

60%

(17%−93%)

Shield [76]

[Guardant Health]

Blood

Fragementomic evaluation of cfDNA

Prospective trial of 7861 participants

13.2%

(11.3% – 15.3%)

ColoDefense2.0 [VersaBio Technologies] [77]

Blood

2 gene metylation status (Septin-9 and SCD2)

Retrospective case–control study

(N = 529)

55.0%

(38.6% – 70.4%)

Coloclear

[Prenetics] [78]

Stool

Haemoglobin + 

KRAS mutations + 

4 gene methylation status (BMP3 promoter, NDRG4 promoter, β‐Actin, and B2M)

ColoClear (vs. FIT) in a prospective screening study of high-risk CRC individuals (N = 4,758)

63.5%

(58.6% – 68.3%)

Freenome [79]

[Freenome]

Blood

Multiomics

48,995 screen-eligible adults aged 45–85, using colonoscopy as reference method

12.5%

(11.3% – 13.8%)