Most of the presently available cancer markers are neither specific fo
r malignancy nor allow early diagnosis. However, the recent elucidatio
n of the molecular events occurring during tumorigenesis may provide n
ew markers that are likely to be both specific for cancer and sensitiv
e for early disease. The key molecules undergoing alterations during c
arcinogenesis are the cellular oncogenes and suppressor genes. Alterat
ions in these genes can be detected in cells shed from malignant and p
remalignant lesions. Thus, mutant p53 genes have been found in urine f
rom patients with bladder cancer, mutant ras genes in stools from pati
ents with colorectal and pancreatic cancers, and both mutant p53 and r
as genes in sputum from patients with lung cancer. These findings show
that the genetic alterations in cancer can be detected in fluids or s
ecretions that had contact with the malignant tissue, The preliminary
studies, however, had small numbers of both patients and controls and
used time-consuming, labor-intensive, and expensive assays. For routin
e applications, these assays must be simplified, automated, and tested
for sensitivity, specificity, and predictive value.