Cancer Detection with the AMAS Test
Predictive Value of the Anti-malignin Antibody Serum (AMAS) Test in Early Breast Cancer
Principal Investigator: S. Mitchell Harman, MD, PhD
Co-investigators: Panayiotis D. Tsitouras, MD, Frank Gucciardo, PA, Christopher Heward, PhD, Per Granström, MD, Belinda Barclay-White, MD, Julio Ibarra, MD, Lowell Rogers, MD
Cancer is a feared diagnosis. It is the second most common killer (after coronary heart disease) of U.S. citizens. It has been estimated that of the nearly 600,000 deaths occurring yearly from cancer, approximately half could be saved by early diagnosis and treatment. Survival rates are directly and closely related to stage at diagnosis for a variety of cancers, with large differences in survival when early and late stages are compared. Although part of the apparent increase in survival with early diagnosis is an artifact of the longer time to mortality when cancer is detected in its initial stages, (without any real alteration of the natural history of the disease) some of the increase in survival also reflects the greater effectiveness of available treatments when they are employed early. Unfortunately, less than 20% of common cancers are diagnosed in Stage I. Therefore, improvements in the methods of screening for and detecting early stage cancers are highly desirable.
Results of 20 years experience, during which data from over 5,000 patients was analyzed, suggest that a test that quantifies anti-malignin antibody (AMAS test, performed at Oncolabs, Inc., Boston, MA) detects more than 97% of patients harboring active cancers, whether occult or manifest, and has less than a 5% false positive rate. This research, performed almost exclusively by the originator of the test and proprietor of the commercial laboratory, lacks sufficient independent verification to be widely accepted, despite approval by the FDA and Medicare accreditation of the test. If such results could be reproduced and independently verified it would represent a major step forward in the methodology of clinical cancer detection and management. On the other hand, if results show the test to be non-discriminating, this finding should be made available to the medical/scientific community.
| Procedures |
Participants were seen by the attending radiologic physician who explained the study and obtained informed consent. A certified medical technician, nurse practitioner, PA, or physician drew 15 ml of blood for the AMAS test, which was submitted blinded to Oncolabs. Breast biopsies were read by two highly skilled board certified surgical pathologists. Patients were not informed of the result of the AMAS test. |
Collaborating Institution
- Christopher B. Heward, PhD, Kronos Science Laboratories, Phoenix, Arizona
- Per Granstrom, MD, University of Arizona Breast Center, Tucson, Arizona
- Belinda Barclay-White, MD, Breastnet, LLC, Scottsdale, Arizona
- Lowell W. Rogers, MD, Memorial Care Breast Center, Department of Pathology, Long Beach California
- Julio A. Ibarra, Jr. MD, Orange Coast Memorial Medical Center, Fountain Valley, California
Outcome: 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 Mg/mL or S-Tag > 220 Mg/mL (P = 0.015). We concluded that 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 the test to be useful for population screening.
Journal Publication: Cancer Epidemiol Biomarkers Prev 2005;14(10): 2310-5
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