This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Harman, S. M. Articles by Ibarra, J. A. Search for Related Content PubMed PubMed Citation Articles by Harman, S. M. Articles by Ibarra, J. A., Jr.

Discrimination of Breast Cancer by Anti-Malignin Antibody Serum Test in Women Undergoing Biopsy

¹ Kronos Longevity Research Institute; ² Kronos Science Laboratories, Phoenix, Arizona; ³ University of Arizona Breast Center, Tucson, Arizona; ⁴ Breastnet, LLC, Scottsdale, Arizona; ⁵ Memorial Care Breast Center, Department of Pathology, Long Beach California; and ⁶ Orange Coast Memorial Medical Center, Fountain Valley, California

Requests for reprints: S. Mitchell Harman, Kronos Longevity Research Institute, 2222 North Highland, Suite 220, Phoenix, AZ 85016. Phone: 602-778-7484; Fax: 602-778-7485. E-mail: harman{at}kronosinstitute.org

Purpose: 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.

Subjects and 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 µg/mL or S-Tag > 220 µg/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.