by CancerBlaster on Mon Dec 13, 2004 12:05 am
About AMAS technology
The AMAS test measures serum levels of AMA, an antibody found to be elevated in most patients with a wide range of active non-terminal malignancies.
AMA is the antibody to Malignin, a 10,000 Dalton polypeptide which has been found to be present in most malignant cells regardless of cell type or location. Unlike tests such as CEA , which measure less well-defined antigens whose serum levels tend to be inconstant but elevated late in the disease, the AMAS test measures a well-defined antibody whose serum levels rise early in the course of the disease. In some cases, the AMAS test has been positive (elevated) early , i.e. 1 to 19 months before clinical detection.
All of the data, from both Bogoch et al. (ref.4) and from the independent study performed by SmithKline Laboratories(ref.6) 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% and false negatives 7% (3,315 double-blind tests of patients and controls).
Anti-Malignin Antibody is elevated in 93-100% of cases in which active non-terminal malignancy is the clinico-pathological diagnosis; overall asymptomatic (’false’) positives are 5% in sera kept shipped overnight. AMA is normal in 96% of cancer patients who no longer have evidence of disease (refs.4,6). Within-run, inter-technician-same-lab, and inter-lab variability are low, as reported in the Smith-Kline study(ref.6).
Every AMAS test is run under rigorous quality control. Control solutions containing known amounts ofstandard monoclonal AMA are run with each test. AMA, when produced in vivo as mouse (ref.3) or as human (ref.7) immunoglobulin, and when isolated from human serum (ref.7) is predominantly IgM. Target® reagent shelf life is as long as 7 years.
AMAS and diagnostic data
Both monitoring data (ref.4) and a retrospective survival study of 511 cancer patients (ref.6) 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 prognosisis poor. Anti-Malignin Antibody is the first general cancer antibody found 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 or gan and the presence of metastases in lymph nodes, or general symptoms such as anemia, weight loss and fatigue.
AMAS and survival data
Both monitoring data (ref.4) and a retrospective survival study of 511 cancer patients (ref.6) 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 found 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 or gan and the presence of metastases in lymph nodes, or general symptoms such as anemia, weight loss and fatigue.
Taking the test
Please ask your doctor about taking the AMAS test. Physicians around the country are recommending and administering the AMAS test on a regular basis for patients at high risk for cancer, and for followup purposes on patients already diagnosed and/or treated for cancer. If your doctor is not familiar with the test and does not have a shipping kit, please call and we can send a free kit. The kit contains reprints of scientific papers on the test a requisition form, and all supplies for drawing and sending a blood serum sample. The kit includes a Styrofoam packing box and silicone-free test tubes, as well as step-by-step instructions for the lab. The only other requirements are a centrifuge and a local supplier of dry ice for shipping (dryicedirectory.com). Your doctor should receive the results within 72 hours of our receiving the serum sample.
Doctors and labs
Oncolab now has expanded nationwide directories of physicians who are familiar with the test, and laboratories with experience drawing and shipping samples for the test. For assistance locating a physician or lab in your area, please call us at 617-536-0850, 9AM-5PM EST, Monday through Friday.
Medicare and Insurance
The AMAS test is covered by standard Medicare reimbursement to Oncolab. While we do not work directly with private insurers, HMOs or PPO plans, we can provide you with a receipt which you may be able to use to get reimbursement from your provider.
Quotes from physicians
Carol Ann Ryser, M.D.
"I believe that people with high risk in their family of cancer, or people over 45 or 50 should definitely take the test. People over 45 or 50 should be screened with the AMAS® Test in the same way people receive routine mammographies and other kinds of tests including the PSA. I think the AMAS® Test should be included.
In my practice I’ve also used this test effectively in patients with clinical symptoms that are not clear: i.e . vague clinical symptoms. To give you a short example a 35 year old woman was having pelvic pain and she had just delivered a baby. She had seen several physicians. They diagnosed here with irritable bowel but they didn’t know what was going on, so she came to see me. I did the AMAS® because the pain was getting more severe and more intense for her and no one could see anything. The AMAS® TEST was positive. So I called one of my Oncology/Gyn friends and said you have got to look over this lady very carefully. There is something going on in her pelvis. Amazingly they found a small malignant tumor at the junction of the cervix and the vaginal wall –a very small little knot. They took it out. The pain went away. Her AMAS® came back to normal after three or four months and that was two or three years ago and she’s been healthy ever since. It was a malignant tumor. It is phenomenal. And of course her family is grateful, three children, and her husband. Most people who come in will have some area in their body they are complaining about. She had focused discomfort and pain- clinical symptoms. When you zero in on that area first and then you expand to other general evaluations, you usually are able to find the source of the problem. This a classic example where a young lady would have probably developed severe cancer over the next two years. It was exciting to find the cancer early.
I rely on colleagues in the relevant areas of specialty to explore the lung, the breast. They do their part of the evaluation. I use the AMAS® Test with my patients as part of the total review which includes family history, personal history, physicians review. I use all of the diagnostic tests together.”
Carol Ann Ryser, M.D.
Kansas City, MO
Limitations and Warnings
The low false-positive and false-negative rates (<1% on repeat determinations of 24-hour sera) have permitted successful screening in selected high-risk populations, as in chemical workers and in the preclinical detection of cancer in 2.3% of medical-surgical cases, but the efficacy of screening in larger normal populations has yet to be determined.
A normal AMA level can occur in non-cancer, in terminal cancer, and in successfully treated cancer in which there is no further evidence of disease; clinical status must be used to distinguish these states.
As in all clinical laboratory tests, the AMAS®Test is not by itself diagnostic of the presence or absence of disease, and its results can only be assessed as an aid to diagnosis, detection or monitoring of disease in relation to the history, medical signs and symptoms and the overall condition of the patient.