Development of radioimmunoassay of intact laminin and its clinical evaluation as a tumor marker.

The concentration of laminin including laminin variants in serum samples was measured by a double-antibody radioimmunoassay using intact laminin. The mean level in 92 normal subjects (47 men and 45 women) was defined as 1 unit (U)/ml, and the cut-off value (2 S.D. above the mean) was 1.37 U/ml. Mean laminin level in 391 patients with various malignancies was 1.50 +/- 0.86 U/ml. Laminin levels were elevated in various cancer patients, and in 45.0% (176/391) the values exceeded the cut-off level; in patients with cancer of the stomach or pancreas, positivity rate exceeded 60%. Mean laminin concentration for 130 pregnant women (2.06 +/- 0.65 U/ml) was also significantly higher than that of normal controls, but concentrations for patients with various benign diseases were within a low range (0.55 +/- 0.29-1.10 +/- 0.29 U/ml). In the stomach or pancreas cancer patients, a positive correlation between laminin level and tumor progression or course of the disease was observed. These findings indicate that serum laminin level is potentially useful in the diagnosis and monitoring of certain cancers.