Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1986-04-24
1989-04-04
Rosen, Sam
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 4, 436 64, 436512, 436543, 436545, 436813, C12Q 100
Patent
active
048186821
DESCRIPTION:
BRIEF SUMMARY
This invention relates primarily to methods and systems for the diagnosis of mucinous cancers, particularly cancer of the gastrointestinal tract, as well as cancer of the breast, lung, stomach, ovary, and the like.
The mortality due to cancer of the intestinal tract ranks second only to that of lung cancer in men and breast cancer in women. Although much attention has been paid to these conditions, the death rate has not been significantly reduced in recent years. Early detection is essential for improvement to occur in the survival figures. Cancer cells at times produce substances which are undetectable or found only in very low levels in healthy individuals. This feature can be used to develop innovative diagnostic techniques. Tests aimed at detecting these cancer-associated substances are of great assistance in the differentiation between individuals with cancer in comparison with healthy individuals.
Carcinoembryonic antigen (CEA) is the most extensively investigated antigen associated with gastrointestinal cancer and indeed the most studied of all tumour-associated antigens. This antigen is present in the human fetal gastrointestinal tract, but is not present or is present at only low levels in the normal adult colon. CEA was first demonstrated in human colonic cancers by Gold and Freedman in 1965..sup.9 CEA was present in the blood of such cancer patients and therefore intially regarded as an oncofetal antigen which gave great hope for the early diagnosis of cancer of the human digestive system. Subsequently it has been shown that assay of CEA in blood is not specific enough to be of value for the early diagnosis of gastrointestinal cancer because it is often elevated in a number of non-neoplastic conditions including smokers' bronchitis and liver disease..sup.10 For instance, 10% of the normal population shows false positive results, in the sense that these individuals have elevated blood CEA levels although they do not have cancer or even benign tumours. Secondly, CEA is often undetectable even in patients with rather large tumours,.sup.11-13 i.e. there is a considerable false negative rate (about 50% of patients with gastrointestinal cancer do not show increased blood CEA levels). Despite these limitations, however, CEA assay is still of considerable value in preoperative assessment and postoperative management of cancer patients. CEA assays account for about 40% of current cancer tests.
Alpha fetoprotein (AFP) is another oncofetal antigen found in high levels in the fetus but not in normal adults. Increased blood levels of AFP are present in patients with primary liver cancer, secondary tumours of the liver, the majority of cases of some types of testicular cancer (teratoma); but also in toxic liver injury and cirrhosis. Despite this apparently limited usefulness, AFP represents about 20% of currently performed cancer tests.
Recently, monoclonal antibody-based radioimmunoassays for the measurement of the tumour-associated antigen CA 19-9.TM., have become commercially available.sup.14-19. This CA 19-9.TM. assay is claimed to have high sensitivity and specificity for all stages of pancreatic cancer, however, with respect to the detection of colorectal cancer, this assay seems to have low sensitivity.
In 1980, a new mucin glycoprotein antigen was isolated from cancer of the large bowel..sup.1 This substance is also present in normal adult small intestine and has therefore been named "small intestine mucin antigen" (SIMA). SIMA was shown to be an oncofetal antigen, in that in the 8-12 week old fetus it is found throughout the gastrointestinal tract, by the time of birth is no longer detected in normal circumstances other than the small intestine, but SIMA is found in cancer of many parts of the gatrointestinal tract and other organs. Another mucin substance, referred to as "large intestine mucin antigen" (LIMA) has also been isolated from normal large intestine. LIMA has also been shown to be an oncofetal antigen, and is produced to a varying extent by a number of cancers. Extensive immunohistologica
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Rosen Sam
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