CUB and zona pellucida-like domain-containing protein 1 (CUZD1): a novel serological biomarker for ovarian cancer.

ObjectivesTo measure the levels of serum CUB and zona pellucida-like domain-containing protein 1 (CUZD1) in patients with ovarian cancer (OvCa), benign gynecological conditions and healthy women and in a number of other cancer types (breast, colorectal, lung, prostate and testicular).Design and methodsSerum CUZD1 levels were measured with a commercial enzyme-linked immunosorbent assay (ELISA). All specimens were analyzed in duplicate. Preliminary verification was performed in serum using 9 healthy women and 20 late stage (III-IV) OvCa patients. An independent cohort of serum samples was used to validate the verification results (18 late stage OvCa, 8 benign gynecological conditions and 8 healthy controls). The following specimens were used for the other cancer types of unknown stage-breast (n=11), colorectal (n=10), lung (n=10), prostate (n=15) and testicular (n=10).ResultsSerum CUZD1 was significantly elevated in ovarian cancer patients (range 95-668 μg/L) as compared to healthy controls (range 0.7-2.5 μg/L). The independent cohort of OvCa samples confirmed the preliminary verification results. CUZD1 was also elevated in breast and lung cancer specimens and not in colorectal, prostate and testicular cancer specimens.ConclusionsCUZD1 appears to be a highly promising novel serum biomarker for OvCa diagnosis. Its performance in the 2 independent cohorts examined, and in lung and breast cancer patients warrants further investigation.