X-Message-Number: 12444 Date: Mon, 20 Sep 1999 21:04:44 -0700 From: Olaf Henny <> Subject: Why Is This Cancer Detection Not Used. I stumbled over a couple of abstracts in Medline, which describe an apparently simple method to detect if any cancer is present in a body. If this method is as effective as claimed (95% on first test; 99% on second) it would safe an enormous amount on healthcare cost in cancer treatment due to early detection. So why are there no fast-track approvals? Why does the FDA or whoever is responsible for such approvals in Italy, Israel or everywhere else not run with it? Not enough money (profit) in marketing such tests to warrant the expenditures of large scale studies? Resistance by the large pharmaceutical companies, which prefer the no doubt profitable sale of medications? I'd like to know. Best, Olaf Cancer Detect Prev 1994;18(1):65-78 Early detection and monitoring of cancer with the anti-malignin antibody test. Abrams MB, Bednarek KT, Bogoch S, Bogoch ES, Dardik HJ, Dowden R, Fox SC, Goins EE, Goodfried G, Herrman RA, et al Beth Israel Hospital, New York, NY. The serum anti-malignin antibody (AMA) test determines the antibody to malignin, a 10,000-Da peptide present in patients with a wide variety of cancers. A total of 3315 double-blind tests demonstrated that AMA is a general transformation antibody, elevated in active nonterminal cancer, regardless of the site or tissue type, with sensitivity and specificity of 95% on the first determination and > 99% on repeat determinations. Data have not however been published yet that indicate whether, in daily clinical practice, the AMA test provides accurate prospective and predictive information. Forty-two physicians from 11 states, who ordered the AMA test, performed blind, report here on their results on 208 determinations in the first consecutive 181 patients and controls. Used in monitoring treatment in 56 patients, the test predicted or agreed 94.1% overall with the clinical status. Used in early detection in 125 patients and controls, of which 118 now have confirmed diagnoses, AMA was elevated in 21, all of whom were proven to have cancer; AMA was normal in 97, none of whom had cancer. Transient elevated AMA occurred in 3%, followed by normal values. Seven patients with still uncertain diagnosis who have had elevated AMA on repeated tests for 1 year or longer include six who are symptomatic, and three whose families have a high frequency of cancer. The conditions of these 7 may include undetected cancer because of the 118 with now certain diagnosis the AMA test predicted all correctly. From our experience, the AMA test should be used together with other routine procedures whenever signs and symptoms suggest cancer to facilitate early detection. PMID: 8162608, UI: 94215202 Int J Biol Markers 1997 Oct-Dec;12(4):141-7 Anti-malignin antibody evaluation: a possible challenge for cancer management. Botti C, Martinetti A, Nerini-Molteni S, Ferrari L Nuclear Medicine Division, National Cancer Institute, Milano, Italy. The major problem in the management of cancer is the difficulty of an early diagnosis. Clinical signs and symptoms generally appear late in the course of the disease. The availability of a non-invasive test which detects a blood molecule closely associated with the malignant transformation of the cells could be of help in the early detection of cancer. Malignin is a 10 kDa polypeptide located in the cytoplasmic and outer membranes of all malignant cells. Anti-malignin antibodies (AMAs) are IgM immunoglobulins spontaneously produced by the host against the oncoprotein malignin when neoplastic transformation occurs; since AMAs are IgM, they can represent an "early" transformation indicator useful for the early detection of cancer. Elevated AMA serum concentrations, measured by means of TARGET@ reagent, have been demonstrated in patients with a wide spectrum of non-terminal active cancers, regardless of the anatomical site and histotype of the tumor. The AMA test showed a sensitivity and specificity of 95% on first determination and > 99% on repeated determinations, and has been reported to be a promising diagnostic tool for the early detection of cancer, as well as for monitoring of the response to treatment and possibly for screening of an asymptomatic population. Publication Types: Review Review, tutorial PMID: 9582602, UI: 98243408 Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=12444