Table 3.

Comparison of site-specific sensitivity of Cologuard in the MSDT study⁷ and of FOB Gold in the BLITZ study

Most advanced finding at screening colonoscopy*	Cologuard, MSDT study7			FOB Gold, BLITZ study
				Ntotal	Original cutoff				Adjusted cutoff
	Ntotal	Npos	Sensitivity % (95% CI)		Npos	Sensitivity % (95% CI)	Difference^ % (95% CI)	p-value^	Npos	Sensitivity % (95% CI)	Difference^ % (95% CI)	p-value^
Proximal CRC	30	27	90.0 (73.4 to 97.9)	5	5	100 (47.8 to 100)	10.0 (−33.9 to 25.6)	1.00	5	100 (47.8–100)	10.0 (−33.9 to 25.6)	1.00
Proximal APCL	431	143	33.2 (28.8 to 37.8)	141	28	19.9 (13.6 to 27.4)	−13.3 (−20.7 to −4.8)	0.001	53	37.6 (29.6 to 46.1)	4.4 (−4.4 to 13.7)	0.36
Proximal CRC or APCL	461	170	36.9 (32.5 to 41.5)	146	33	22.6 (16.1 to 30.3)	−14.3 (−21.8 to −5.7)	0.001	58	39.7 (31.7 to 48.1)	2.9 (−6.0 to 12.0)	0.56
Distal CRC	35	33	94.3 (80.8 to 99.3)	25	24	96.9 (79.6 to 99.9)	1.7 (−14.4 to 15.0)	1.00	24	96.9 (79.6 to 99.9)	1.7 (−14.4 to 15.0)	1.0
Distal APCL	325	177	54.5 (48.9 to 60.0)	236	104	44.1 (37.6 to 50.7)	−10.4 (−18.6 to −2.0)	0.017	132	55.9 (49.3 to 62.4)	1.5 (−6.8 to 9.7)	0.73
Distal CRC or APCL	360	210	58.3 (53.1 to 63.5)	261	128	49.0 (42.8 to 55.3)	−9.3 (−17.1 to −1.4)	0.023	156	59.8 (53.5 to 65.8)	1.4 (−6.4 to 9.2)	0.74

Notes: Results for FOB Gold are derived for the original cutoff given by the manufacturer (17 µg hb/g feces) and for an adjusted cutoff (8.4 µg hb/g feces) yielding the same specificity with respect to advanced neoplasms (86.6%) as reported for Cologuard. APCL including advanced adenomas and sessile serrated polyps ≥1 cm; N_pos, number of positive results.

^*Participants with the respective most advanced finding in both the proximal colon and distal colon or rectum were included in site-specific analyses for both sites.

^{^}Differences and p-values refer to comparison with Cologuard.⁷ p≤0.05 are in bold.

Abbreviations: MSDT, multitarget stool DNA test; APCL, advanced precancerous lesion; CRC, colorectal cancer; N_pos, number of positive results.