. 2022 Mar 16;17(3):e0264138. doi: 10.1371/journal.pone.0264138

Table 5. Clinical utility of F1CDx for BRCA1/2 alteration companion diagnostic claims.

Therapy	Clinical endpoint	F1CDx results	Full analysis set results
Olaparib	PFS^a, months	N = 206	N = 260
	HR^b (95% CI)	Not reached	Not reached
	HR^b (95% CI)	0.28 (0.20, 0.38)	0.30 (0.23, 0.41)
Rucaparib	PFS^c, months	N = 124	NR
	HR^b (95% CI)	16.6	NR
	HR^b (95% CI)	0.23 (0.16, 0.34)	NR

CI = confidence interval; F1CDx = FoundationOne^®CDx; HR = hazard ratio; NR = not reported; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumors.

^a Investigator-assessed median PFS evaluated according to RECIST v1.1.

^a HR for both F1CDx and full analysis set (olaparib only) compares olaparib or rucaparib to placebo for risk of disease progression or death.

^c Investigator-assessed median PFS.