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 

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