Analysis of Serum Proteomic Patterns for Early Cancer Diagnosis: Drawing Attention to Potential Problems

Abstract

In a recent update (1) of already impressive data (2), it was reported that the use of proteomic patterns in serum to diagnose ovarian and prostate cancers can achieve perfect diagnostic sensitivity and specificity. A diagnostic sensitivity and specificity of 100% is unprecedented for any tumor marker known to date and, if reproducible, this finding could have a major impact on the way we diagnose cancer in the future. Over the last 2 years, results reported by several groups (2–6) have suggested that such proteomic patterns, particularly those generated by surface-enhanced laser desorption/ionization time-of-flight (SELDI-TOF) mass spectrometry, may facilitate the early diagnosis of various cancers, including those of the ovary, prostate, breast, and bladder. SELDI-TOF proteomic profiling technology has been reviewed (7,8). The impressive results reported with this new technology were welcomed by scientists, the popular press, the public, and even by politicians (9). Although there has been little published criticism of this methodology (10–12), serious skepticism about its utility has been expressed publicly at various scientific meetings. Many investigators and clinicians have adopted a wait-and-see approach pending the outcomes of prospective clinical studies using this technology which are starting now but will require years to complete.