Soluble epidermal growth factor receptor-like proteins and their uses in cancer detection methods
AssigneeTumor Biology Investment Group, Inc.
InventorsAndre T. Baron, Nita J. Maihle
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Abstract
The present invention relates to the discovery of soluble isoforms of an Epidermal Growth Factor Receptor, or sErbB 1/HER1 variants, the provision of the sequences of nucleic acids encoding these isoforms, purified recombinant proteins, novel antibodies specific for these isoforms, and the use of immunoassay and gene expression assay techniques to measure the concentration of these gene products in a patient biological sample. The present invention also provides methods for determining the presence of an ovarian carcinoma in the patient by assaying the concentration of soluble EGFR/ErbB1 variants in a biological sample from a patient.
Claims15
An assay for determining the concentration of a soluble epidermal growth factor receptor in a biological sample from a female patient, the assay comprising:
- a) obtaining a biological sample from the female;
- b) contacting an amount of a first purified antibody that specifically reacts with a first epitope of the extracellular ligand binding domain of soluble epidermal growth factor receptor with the biological sample to be tested, wherein the first purified antibody is modified with a first labeling moiety;
- c) contacting the sample with an amount of a second purified antibody that specifically reacts with a second epitope of the extracellular ligand binding domain of soluble epidermal growth factor receptor, wherein the second purified antibody is modified with a second labeling moiety, and wherein the second purified antibody does not competitively inhibit the binding of the first purified antibody;
- d) detecting the co-presence of the first and second labels to determine the concentration of the soluble epidermal growth factor receptor complexed with the antibodies;
- wherein one of the antibodies is chosen from the group consisting of mAb R.1 and an antibody which binds to the same epitope as mAb R.1;
- and wherein the other antibody is chosen from the group consisting of mAb 528 and an antibody which binds to the same epitope as mAb 528;
- e) comparing the concentration of soluble epidermal growth factor receptor obtained in step d) with a normal value;
- and
- f) correlating a decrease in the concentration of soluble epidermal growth factor receptor in the patient biological sample with the presence of an ovarian carcinoma in the patient.
Dependencies are inferred from the claim text.