The new DR‐70 immunoassay detects cancer of the gastrointestinal tract: a validation study

SummaryBackground : Malignant cells characteristically possess high levels of plasminogen activator, which induce local fibrinolysis. The DR‐70 immunoassay is a newly developed test, which quantifies fibrin degradation products in serum by a proprietary antibody.Aim : To evaluate the DR‐70 immunoassay as a detection assay for the presence of gastrointestinal cancers.Methods : We prospectively collected blood sera of 85 patients with histologically proven tumour and 100 healthy blood donors. Ten microlitres of the sera was used for the DR‐70 immunoassay. Nineteen patients had a hepatocellular and 10 cholangiocellular carcinoma, 13 cancer of the pancreas, 30 colorectal cancer, 10 stomach cancer and three cancer of the oesophagus.Results : Receiver–operator curve analysis revealed <0.7 μg/mL as the best cut‐off value to distinguish between patients with cancer and healthy controls. Using this cut‐off value, the DR‐70 immunoassay showed a good clinical performance with a sensitivity of 91% and a specificity of 93%. Patients with advanced tumour spread showed significantly higher DR‐70 values than those with early‐stage tumours (P < 0.0003).Conclusion : The DR‐70 immunoassay reliably differs between cancer patients and healthy controls. Therefore, it promises to become a useful test for the detection of cancer in clinical practice.