Comparison of serum CYFRA 21-1 and ROMA in distinguishing ovarian cancer from benign pelvic masses.

e15565 Background: CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (OC) versus those with benign gynecological diseases, serum CYFRA 21-1 was reported sensitivities (SN) of 44% and 41% at specificity (SP) of 95% for OC detection using an ELISA assay by Hasholzner U (1994) and Tempfer C (1998), respectively. Nolen B (2010) reported a SN of 84.1% and 85.8% and a SP of 85% and 79.3% with a combination of CYFRA 21-1, CA 125 and HE4 using a multiplex bead-based immunoassay in a training and validation set, respectively. We carried out a cohort study to evaluate the serum CYFRA 21-1 as an ovarian cancer biomarker and compared it with ROMA (Risk of Ovarian Malignancy Algorithm), an FDA-cleared ovarian cancer algorithm. Methods: ARCHITECT CYFRA 21-1 assay was used to measure the levels of serum CYFRA 21-1. Single point serum samples from 170 female subjects with a pelvic mass were randomly selected from an archive cohort of female subjects. Among the 170 subjects, 47 had OC (42 with e...