All of the data, from both Bogoch et al. (ref 04) and from the independent study performed by Smith-Kline Laboratories (ref 06) support the fact that the AMA (Anti-Malignin Antibody) is elevated almost regardless of the site or cell type of the malignancy; that is, AMA is a general transformation antibody, not just for one particular kind of cancer. For sera shipped overnight, false positives are 5 percent and false negatives 7 percent (3,315 double-blind tests of patients and controls,
Anti-Malignin Antibody is elevated in 93 to 100 percent of cases in which active non-terminal malignancy is the clinical-pathological diagnosis. Overall asymptomatic ('false') positives are 5 percent in sera shipped overnight (ref 04-08).
AMA is normal in 96 percent of cancer patients who no longer have evidence of disease (ref 04, 06). Internally run, inter-technician-same-lab, and inter-lab variability are low, as reported in the Smith-Kline study (ref 06).
Both monitoring data (ref 04) and a retrospective survival study of 511 cancer patients (ref 06) have shown that the AMAS test may be useful in indicating disease progression and prognosis. Thus in known cancer patients, when the immune response is good as evidenced by high antibody levels, the prognosis is good. And when the antibody level falls, the prognosis is poor.
Anti-Malignin Antibody is the first general cancer antibody to relate to patient survival. The test therefore may be useful as an adjunct to standard (sometimes less accurate) staging information such as the spread of malignancy beyond the capsule of the primary organ and the presence of metastases in lymph nodes, or general symptoms such as anemia, weight loss, and fatigue.
Control solutions containing known amounts of standard monoclonal AMA are run with each test. AMA, when produced in vivo as mouse (ref 03) or as human (ref 07) immunoglobulin, and when isolated from human serum (ref 07) is predominantly IgM. Target® reagent shelf life is as long as 7 years.