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The completion of the human genome project and the bur- geoning use of genomic, transcriptional profiling, and proteomic technologies to investigate DNA, RNA, and protein levels in tumors, serum, plasma, and urine offer the exciting potential of identifying novel and effective cancer-specific screening mark- ers. If the markers are secreted or released from tumor cells and migrate to serum, plasma, urine, or other accessible sites, they may be useful as screening markers either alone or in combina- tion with currently identified tumor markers or screening ap- proaches. Thus, these technologies potentially provide for a rapid advance in the identification of novel tumor markers com- parable to that initiated by the introduction of monoclonal anti- body technology. In this issue of the Journal, Mok et al. (1), using transcrip- tional profiling of ovarian cancer cell lines, found that messen- ger RNA (mRNA) levels of prostasin (a serine protease, previ- ously identified in prostatic secretions), osteopontin (a secreted bone morphogen), and creatine kinase B (a marker for renal and lung cancers) are higher in ovarian cancer cell lines than in normal ovarian epithelial lines. Prostasin mRNA and protein levels subsequently were found to be markedly elevated in ovar- ian cancer cell lines and in ovarian cancer tissue. The prelimi- nary data presented by Mok et al. (1) suggest that prostasin is released from ovarian cancer cells, migrates to the bloodstream, and may be a novel marker for the diagnosis or management of ovarian cancer. This is exciting evidence that global, nondi- rected screening approaches at the level of DNA, RNA, or pro- tein may identify a series of markers complementing those found previously by antibody-based or candidate gene approaches. Prostasin has low sensitivity in early-stage disease and lower sensitivity than CA 125, the best characterized marker for ad- vanced epithelial ovarian cancers. Similar to CA 125 (2-4), prostasin levels were frequently elevated in serum from patients with serous epithelial ovarian cancers, with limited increases in serum from patients with mucinous tumors or serous borderline tumors. A lack of correlation between CA 125 and prostasin suggested that combining the two markers could increase the sensitivity. Indeed, in a screen of 37 patients and 100 control subjects, Mok et al. (1) reported that this combination resulted in 92% sensitivity (95% confidence interval (CI) 78.1% to 98.3%) and 94% specificity (95% CI 87.4% to 97.7%), com- pared with a sensitivity of 64.9% (95% CI 47.5% to 79.8%) for CA 125 and of 51.4% (95% CI 34.4% to 68.1%) for prostasin at a specificity of 94% for prostatin in the same set of samples.

Future for Ovarian Cancer Screening: Novel Markers From Emerging Technologies of Transcriptional Profiling and Proteomics