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Frequently Asked Questions (FAQs):

1) What is the Anti-Malignin Antibody in Serum (AMAS) Test?
2) What special value does the AMAS Test have?
3) Who is Dr. Samuel Bogoch?
4) How does the AMAS Test work?
5) Is the cost of the AMAS Test covered by the Medical Services Plan of B.C.?
6) Who will help me interpret the results?
7) What happens if I get a positive result?
8) How do I access the AMAS Test?
9) May I speak with someone at Somasave directly about questions regarding accessing the AMAS Test?

1) What is the Anti-Malignin Antibody in Serum (AMAS) Test?

The Anti-Malignin Antibody in Serum (AMAS) Test is a blood test that is valuable as an aid in the detection, diagnosis and monitoring of cancer present virtually anywhere within the human body. While many medical practitioners in British Columbia seem generally unaware of the AMAS Test, it has had an excellent track record in the United States established over many years. Although the AMAS Test was first made available in 1977 through Oncolab Inc. (the Boston-based laboratory of its discoverer, Dr. Samuel Bogoch), clinical trials involving more than 4000 patients that validated the test's effectiveness were only completed in 1994.

The AMAS Test has been granted "permission to market" status by the United States Food & Drug Administration, and the US Medicare system pays for the AMAS Test for eligible recipients. The AMAS Test is also used by a number of US Health Management Organizations (HMOs).

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2) What special value does the AMAS Test have?

Cancer is a family of diseases that exacts a terrible toll world-wide. Roughly 0.2% of the population of British Columbia die each year from malignant disease. Both the Canadian and the American Cancer Societies have long acknowledged that the key to reducing the harmful effects of cancer is its early detection and early appropriate treatment.

The AMAS Test measures the level of certain anti-cancer antibodies within the blood serum. Unlike most other cancer blood tests (e.g., PSA, CEA, AFP, HCG, CA 15-3, CA 19-9, CA-125, etc), the AMAS Test does not look for the presence of cancer antigens within the bloodstream---a condition, when specific for cancer, that generally reflects a late-stage, relatively large tumor mass (of perhaps 1 billion malignant cells) or metastatic disease. As a consequence of its targeting specific anti-cancer antibodies, the AMAS Test may be used as an aid to the early detection of the presence of relatively small numbers of cancer cells within the body, since even small tumor masses can elicit this immune AMAS response in immuno-competent individuals.

In addition, when "clinical cancer" has been identified and specific anti-cancer treatments initiated, the AMAS Test may be used to monitor the efficacy of ongoing therapy. If tumor eradication is achieved, the AMAS Test can also be used to assess the duration of tumor remission, as well as to detect the later possible return of the "clinical cancer" state.

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3) Who is Dr. Samuel Bogoch?

Dr. Sam Bogoch (MD: Toronto, 1951;PhD: Harvard, 1956), founder of the Neurochemistry Laboratory, Harvard Medical School (1956-1961), taught at Harvard and later at Boston University School of Medicine (1961-1991). While working at Harvard, Dr. Bogoch was among the first to describe the structure of brain gangliosides. Since the late 1950's, Dr. Bogoch has characterized the structure and function of brain glycoconjugates, investigated cell-cell recognition, training, and memory, and studied the nature of malignant transformation in brain cells, as well as the cancer process in other tissue types.

This cumulative body of scientific work by Dr. Bogoch and his colleagues led ultimately to the discovery of the tumor marker malignin---a peptide (protein fragment) present on the surface of cancer cells. Malignin appears to represent a general transformation antigen, produced in cancers of lung, colon, prostate, and breast, as well as in most other common forms of cancer. The discovery of malignin by Dr. Bogoch led shortly thereafter to identification of the presence of specific anti-malignin antibodies within the blood sera of both normal and cancer-afflicted individuals. It is the determination of the relative level of these antibodies within the blood serum (i.e., the AMAS Test) that permits most cancer patients to be distinguished from the vast majority of most normal (clinically cancer-free) individuals.

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4) How does the AMAS Test work?

The characteristics of the AMAS Test described in the following paragraphs are based upon scientific investigations extending over a 30-year period (see Scientific Bibliography on the AMAS Test). In that time, three independent participating laboratories conducted single-blind or double-blind studies of AMAS involving 25,000 human sera, and Oncolab Inc., Boston MA has performed more than 200,000 physician-requisitioned clinical AMAS determinations.

  1. The presence of Anti-Malignin Antibody (AMA) in blood serum represents a marker of malignant transformation (i.e. the conversion of normal body cells to cancerous cells). AMA is a type of IgM antibody (i.e., a soluble protective protein produced by the body's immune system) present in blood and extracellular fluid. AMA specifically binds to a cell-surface protein (i.e., antigen) present on cancer cells. This cancer antigen has been named "malignin".

  2. Malignin is a 10 kilodalton peptide (i.e., a short protein fragment) released from a larger 250 kilodalton membrane glycoprotein (designated by Dr. Bogoch as 10B). Malignin is expressed within the plasma membranes of malignant tumor cells, but not within the membranes of normal cells or benign tumor cells. The reason for this cancer cell-specific expression of malignin is unclear; however, it may reflect the shift of the cell's biochemistry during malignant transformation from aerobic (i.e., oxygen-requiring) metabolism to anaerobic (i.e., non-oxygen-requiring) metabolism.

  3. Low levels of AMA are present in the blood sera of normal individuals, but AMA can rise several-fold (i.e. > 134 µg/ml) within days of the development of "clinical cancer" (i.e., a large malignant cell mass or multiple smaller metastatic tumor masses). This means that small numbers of malignantly transformed cells are present even in normal individuals, and the expression of malignin peptide by these small clusters of cancerous cells accounts for the presence of the low ("normal") levels of AMA in blood serum of "clinically cancer-free" persons.

  4. AMA is an extremely potent cancer cell-specific cytotoxin (i.e., cell poison), killing malignant cells at picogram (10-12 gm) quantities per cell. As such, AMA appears to be a key component of the body's anti-cancer immuno-surveillance system. When AMA levels in blood serum rise, following the emergence of a state of "clinical cancer", successful anti-cancer therapeutic interventions (e.g. cytotoxic drug therapy, radiation, surgery, immunotherapy, etc) lead to a lowering of blood AMA to non-cancer "normal" levels (i.e. < 135 µg/ml) ---a clinical indicator of cancer remission. On average, this change is seen to occur within about 3 months of completion of effective anti-cancer therapy.

  5. "Normal" AMA levels in blood serum (viz., < 135 µg/ml, and even better < 100 µg/ml, since 100-134 µg/ml may be considered "borderline") are seen in normal (non-cancer) individuals, and in successfully-treated cancer patients who are in remission from clinical cancer. In addition, sub-normal or seemingly-normal serum AMA values ("false negatives") may be observed in a significant number of advanced or terminally-ill cancer patients who are in a state of "antibody failure" due to disease-induced immunosuppression (i.e., individuals no longer able to synthesize sufficient amounts of cancer-fighting cells and antibodies, like AMA). Thus, four different clinical states can usually be distinguished by experienced medical practitioners (e.g., oncologists) by consideration of the overall clinical picture of the patient: the normal/non-cancer state, the successfully-treated remitted-cancer state, the active cancer state, and the advanced/terminal-cancer state. For example, it is usually possible to discriminate advanced or terminal cancer patients who may show low-normal or apparently normal AMAS levels from successfully-treated cancer-patients in remission who show normal AMAS Test values. This is a clinical judgement based upon the physician's clinical oncology experience, and is often made on the basis of the presence or absence of cachexia, anemia, paraneoplastic syndromes, etc. Continuing ambiguous cases may often be resolved by repeat AMAS Test determinations, in combination with ongoing monitoring of the patient's other clinical laboratory indices.

  6. Abnormally high serum AMA levels (i.e. > 134 µg/ml) have been observed to be a usual feature of all types of malignancies studied to date by Dr. Bogoch and his colleagues. These include cancers of the breast, lung, and brain, as well as melanomas, lymphomas, leukemias, and colorectal cancer, malignancies of the larynx, uterus, cervix, ovary, anus, stomach, esophagus, prostate, bladder, urethra, kidney, testis, thyroid, and skin, and fibrosarcoma, leiomyosarcoma, osteosarcoma, rhabdomyosarcoma, mesothelioma, liposarcoma, hemangioblastoma. It is noteworthy that normal AMAS Test values are seen in individuals having benign (non-malignant) neoplasms, hyperplastic tissue conditions, inflammatory disorders, etc. It is wise to keep in mind that some late-stage advanced and terminal malignant tumors deceptively give low-normal to normal AMAS Test values.

  7. The AMAS Test shows high accuracy, high sensitivity and high specificity. Based upon published scientific papers and other submissions, the US Food & Drug Administration has granted Dr. Bogoch "permission to market" the AMAS Test with the following FDA-reviewed scientific statement: "If repeat determinations agree, the false-positive and false-negative rates are less than 1% (specificity and sensitivity greater than 99%); in single determinations, false-positives are 5% and false-negatives 7% (3,315 double-blind tests of patients and controls)".

    These low rates of false-positive and false-negative results mean that the AMAS Test appears to be a superior cancer diagnostic aid compared with other currently available tumor markers (e.g., PSA, CEA, AFP, HCG, CA 15-3, CA 19-9, CA-125, etc). These other tumor markers are generally only useful in late-stage cancer detection involving large tumor cell masses and/or multiple metastases, and they often show high false-negative rates during early stages of clinical cancer, as well as high false-positive rates in various benign neoplastic and non-neoplastic disorders and physiological states, erroneously giving blood marker values consistent with a diagnosis of cancer.

  8. The AMAS Test is highly sensitive. The abnormal rise of AMA within blood serum (i.e., to levels greater than 134 µg/ml) is a very early marker of cancer occurring somewhere within the human body and in some instances may be seen up to 19 months prior to diagnosis by standard methods. Recent work from Dr. Bogoch's laboratory suggests that some virally-induced cancers (e.g., hepatocellular carcinomas caused by hepatitis B or C virus) may be detected years in advance by conversion to an AMAS positive state.

    For malignant tumors located in well immuno-surveilled parts of the body, the AMAS Test can detect malignant cell masses smaller than 1 mm in diameter ----a size which represents the presence of a few thousand cancer cells, rather than the billion or more cancer cells that must be present to be detected by standard cancer diagnostic methods. This means that the detection of cancer may often be made during the pre-symptomatic stage of malignant disease, allowing for the possibility of early-initiation of appropriate effective therapy and a potentially better long-term prognosis (i.e. reduced morbidity, better "quality of life", and prolonged survival).


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5) Is the cost of the AMAS Test covered by the Medical Services Plan of B.C.?

No. The AMAS Test has not been submitted to Health Canada for evaluation and approval and therefore is not officially recognized either by the Government of Canada or by the Government of British Columbia. At present, Dr. Samuel Bogoch, MD, PhD (the originator of the AMAS Test) continues to offer this aid to cancer detection, diagnosis and monitoring to patients worldwide from a single site, Oncolab Inc, Boston MA USA. As stated above, the AMAS Test does have official US Food & Drug Administration "permission to market" with the specified FDA-reviewed scientific statement (see FAQ #4, para "g" above).

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6) Who will help me interpret the results?

Patients cannot access the AMAS Test without a physician's authorization, and it is primarily your requisitioning physician's responsibility to help you understand the meaning of the test results and how they might apply to your particular situation. While your physician may not have had previous experience using the AMAS Test and interpreting the results, he/she is encouraged to contact Dr. Bogoch by telephone (1-800-9CATest) for assistance in the appropriate application of AMAS Test results to your case. Personnel of Somasave Products and Services, Ltd. do not interpret AMAS Test results.

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7) What happens if I get a positive result?

It is recommended that a second confirmatory AMAS Test be performed. If the repeat determination agrees with the first test result and indicates the likelihood that you are harboring a malignant tumor, then you and your doctor will need to decide how best to proceed. The AMAS Test may detect cancer up to 19 months before it can be recognized by usual means (i.e., clinical examination, biopsy, laboratory serum assay, diagnostic imaging).

While the AMAS Test is highly specific for cancer, it is non-informative with respect to one's particular cancer type and tumor location(s). Because the AMAS Test is not officially part of the Canadian health care system, the Medical Services Plan of British Columbia will not pay for localization and identification of tumors detected solely on the basis of a positive AMAS Test. Therefore, unless you have other recognizable signs or symptoms referable to a possible neoplasm and requiring investigation, you should be prepared either to wait for the subsequent onset of such disease manifestations or to bear the cost personally of further tumor detection/documentation.

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8) How do I access the AMAS Test?

These are the steps that you will need to follow to access the AMAS Test from Vancouver, B.C. with the assistance of Somasave Products and Services, Ltd. ("Somasave").

  1. You will need to telephone Oncolab Inc., Boston MA (1-800-9CATest) and request that an AMAS Test shipping kit be mailed to you.

  2. When you do receive the AMAS Test shipping kit (in approx. two weeks), you should carefully read the enclosed documentation pertaining to the AMAS Test. Further information is also obtainable online from Dr. Bogoch's website www.amascancertest.com. If you still wish to take the test, make an appointment with your family physician and have him/her help you to complete the 3 forms (listed below). You will need to bring these 3 forms with you to your doctor's appointment and then to your blood collection appointment.

    The forms requiring completion and signature are:

    1. an AMAS Test requisition form for Oncolab Inc., Boston MA (part of the AMAS Test shipping kit sent at your request) (requires both the patient's and physician's signatures),

    2. a blood collection requisition form for MDS Metro (the clinical laboratory drawing the blood specimen) (requires the physician's signature), and

    3. a declaration/authorization/waiver form for Somasave (requires the patient's signature)


    Please Note: these latter two forms (ii & iii, above) are available as downloads from our website www.somasave.com, or can be mailed to you upon request by telephoning us at 604-216-7999 and leaving a message requesting these forms and clearly stating your name, telephone number and mailing address.

  3. Once you and your doctor have completed the forms with signatures (where appropriate), you should call Somasave at 604-216-7999, and we will book an appointment date for your blood draw. AMAS blood draw clinics are held every Tuesday between 9:00 AM and 10:30 AM and only take place at one specific MDS Metro laboratory site in Vancouver. On your appointed date, you should arrive as early as possible bringing with you the 3 fully-completed, signed forms (including credit card information for billing purposes) AND bringing the AMAS Test shipping kit. No blood specimen will be collected without these items. Blood draws are done on a first-come/first-served basis, and must be entirely completed by 10:45 AM to allow time for Somasave staff to pick up the blood from the clinical lab, process it, separate the blood serum, package it in dry ice and send it via FEDEX as a Priority Overnight Delivery to Oncolab, Boston MA. For your test results to have the highest level of accuracy, your blood serum specimen must be received by Oncolab within 24 hours of blood collection.

  4. The total cost of the AMAS Test is $180 CAD + $135 USD. The cost breakdown is as follows:

    1. Canadian costs ($180 CAD total):
      * $25 CAD = the cost of blood sample collection (This fee is paid directly to MDS Metro laboratory by you at the time of your blood draw)

      * $155 CAD = Somasave's fee for facilitating access to the Boston-based AMAS Test (This fee includes the costs of picking up the blood from MDS Metro clinical lab, blood processing and serum separation by the Oncolab-specified protocol, dry ice-packaging and priority overnight delivery via FEDEX to Oncolab Boston. Somasave will bill this fee to the VISA or Mastercard number provided by you on the completed declaration/authorization/waiver form.)

    2. American costs: The $135 USD covers Oncolab's fee for performing the AMAS Test and informing your physician of the test results. Oncolab, Inc., Boston MA will bill this fee to the VISA or Mastercard number provided by you on the completed Oncolab form.


  5. Your physician should receive a fax from Oncolab within 4-5 working days stating your AMAS Test results. Once these data are received, you will need to book an appointment with your doctor to discuss them.


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9) May I speak with someone at Somasave directly about questions regarding accessing the AMAS Test?

If you have any questions relating to these instructions do not hesitate to contact us at our voicemail box (telephone #604-216-7999). Please leave us a message, stating your question, your name and telephone number. We will gladly return your call.

THANK YOU FOR VISITING US AT SOMASAVE.COM!


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