title: Discrimination of breast cancer by anti-malignin antibody serum test in women undergoing biopsy.
abstract: OBJECTIVE
  The anti-malignin antibody serum (AMAS) test (Oncolab, Boston, MA) has been reported as 97% sensitive and 95% specific for malignancies. To objectively assess accuracy of this test for discrimination of breast cancer, we studied a series of women undergoing core breast biopsy.
  
  
  METHODS
  Seventy-one core-needle breast biopsies were classified as malignant, suspicious, or benign by two independent pathologists blinded to AMAS results. Corresponding sera were read as AMAS positive, negative, or borderline by criteria used by Oncolab and also using criteria derived from receiver-operator curves based on values for slow (S-tag), fast (F-tag), and their difference (Net-tag) antibody reported by Oncolab. We calculated sensitivity and specificity and analyzed distributions by Fisher's exact test.
  
  
  RESULTS
  Biopsies were read as 42 (59%) benign, 12 (17%) suspicious, and 17 (24%) malignant. By Oncolab criteria, sensitivity (59%) and specificity (62%) were maximized by pooling suspicious with malignant and AMAS borderline with positive (P = 0.098). Receiver-operator curves showed best sensitivity (62%) and specificity (69%) for the criterion AMAS positive if Net-Tag > 135 microg/mL or S-Tag > 220 microg/mL (P = 0.015).
  
  
  CONCLUSIONS
  The AMAS test discriminates suspicious and malignant from benign lesions, but sensitivity is insufficient to identify patients to be spared biopsy and false-positive rates are too high for population screening.
authors.affiliation: Kronos Longevity Research Institute, 2222 North Highland, Suite 220, Phoenix, AZ 85016, USA. harman@kronosinstitute.org
authors.forename: S Mitchell
authors.initials: SM
authors.lastname: Harman
authors.forename: Frank
authors.initials: F
authors.lastname: Gucciardo
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Heward
authors.forename: Per
authors.initials: P
authors.lastname: Granstrom
authors.forename: Belinda
authors.initials: B
authors.lastname: Barclay-White
authors.forename: Lowell W
authors.initials: LW
authors.lastname: Rogers
authors.forename: Julio A
authors.initials: JA
authors.lastname: Ibarra
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000888:Antibodies, Anti-Idiotypic / Q000097:blood; D014408:Biomarkers, Tumor / Q000302:isolation & purification*; D001707:Biopsy, Needle; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis / Q000473:pathology*; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000097:blood / Q000276:immunology; D012372:ROC Curve; D012680:Sensitivity and Specificity
chemical_list: D000888:Antibodies, Anti-Idiotypic; D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins; C016548:malignin