Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1997-12-18
2001-02-13
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C530S387100, C530S387700, C530S388100, C530S388200, C530S388850, C530S389100, C530S391100, C435S007920
Reexamination Certificate
active
06187549
ABSTRACT:
BACKGROUND OF THE INVENTION
The diagnosis of cancer in individuals has remained a difficult task to accomplish. Although some diagnostic markers are available that are assayable from blood or tissue samples, e.g. Carcinoembryonic Antigen (CEA), Alpha Fetoprotein (AFP) or Prostate Specific Antigen (PSA), the assays using these markers have not, to date, been markedly predictive of the presence of cancer in these individuals, as verified by other clinical diagnoses. The sensitivity and specificity of these assays has been disappointingly low. Time-consuming and labor-intensive clinical assessments (e.g. palpations, x-rays, mammograms, biopsies) have remained the accepted methods for diagnosing cancer. Thus, a need exists for a marker, preferably present in a biological sample, from an individual, such as blood that is predictive of the presence of cancer in the individual. In particular, a need exists for the existence of a marker and an assay to measure the presence and amount of this marker for individuals who have cancer in an early stage. If such a diagnostic test were available, early treatment with beneficial outcomes would be more likely than at present.
It is an object of this invention to provide methods for detecting the presence of primary or metastatic cancer in an individual that involves the detection of a cancer-diagnostic protein. It is also an object of this invention to provide compositions of matter that can be used to detect the presence of primary or metastatic cancer in an individual.
SUMMARY OF THE INVENTION
This invention pertains to methods of detecting cancer in an individual from the results of an assay of a biological sample, such as a blood sample, from the individual. In this assay, the sample is incubated with at least one antibody that is immunoreactive with a cancer-diagnostic protein that may be present in the biological sample. The immunoconjugates that are formed in the cancer-diagnostic protein:antibody reaction are detected. The presence of an abnormally high concentration of these immunoconjugates indicates that the individual from whom the sample was taken has primary or metastatic cancer.
In a preferred embodiment of this invention, the cancer-diagnostic protein is A-protein and the sample is incubated in a sandwich assay for A-protein. An antibody that is immunoreactive with A-protein is attached to a solid support. The sample is allowed to immunoreact with the attached antibody and with a second antibody that is immunoreactive with another region of A-protein (i.e., a region other than the region immunoreactive with the solid support-attached antibody). The resultant two antibodies-A-protein complex thereby forms a sandwich. The amount of bound second antibody is detected. This amount of detected second antibody is directly proportional to the amount of attached A-protein. An abnormally large amount of detected second antibody is indicative of the presence of primary or metastatic cancer that is being detected by the assay of the biological sample.
Another embodiment of this invention is a test kit that contains one or more antibodies to be used in the assay for the cancer-diagnostic protein (e.g. A-protein). One of the antibodies is immunoreactive with one epitopic region of the cancer-diagnostic protein and, if a second antibody is included, the second antibody is immunoreactive with an epitopic region of the cancer-diagnostic protein separate from the epitopic region that is immunoreactive with the first antibody. In a preferred embodiment of the test kit, there are two antibodies that are immunoreactive with two epitopic regions of A-protein. One of the antibodies is attached to a solid support, such as the walls and bottoms of wells of a microtiter plate. The other antibody has a detection label bound to it.
Yet another embodiment of this invention is one or more antibodies that immunoreact with a cancer-diagnostic protein, i.e. A-protein. These antibodies are used to detect or assess the presence of the cancer-diagnostic protein. The assessment can be performed using biological samples such as blood.
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Hoffman Kenneth L.
Schmidt Geoffrey J.
Cytra Corporation
Hamilton Brook Smith & Reynolds P.C.
Huff Sheela
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