title: The new DR-70 immunoassay detects cancer of the gastrointestinal tract: a validation study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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 microg/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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical Department II, University Hospital, Frankfurt/Main, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kerber
authors.forename: J
authors.initials: J
authors.lastname: Trojan
authors.forename: K
authors.initials: K
authors.lastname: Herrlinger
authors.forename: D
authors.initials: D
authors.lastname: Zgouras
authors.forename: W F
authors.initials: WF
authors.lastname: Caspary
authors.forename: B
authors.initials: B
authors.lastname: Braden
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis; D005770:Gastrointestinal Neoplasms / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D005338:Fibrin Fibrinogen Degradation Products