ARL-1 specific antibodies and uses thereof

1. A method for detecting breast cancer or prostate cancer or a precancerous lesion of the breast or prostate, comprising:

contacting, in vitro, a breast tissue sample or a prostate tissue sample from a human with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting expression of the ARL-1 protein in the sample based on said contacting step;

comparing expression of the ARL-1 protein, detected in said detecting step, with expression of the ARL-1 protein in a normal breast tissue sample or a normal prostate tissue sample; and

detecting breast cancer or prostate cancer or precancerous lesion of the breast or the prostate when expression of detected ARL-1 protein is greater than expression of detected ARL-1 protein in said normal breast tissue sample or said normal prostate tissue sample.

2. A method of claim 1 , wherein expression of the ARL-1 protein is detected by in situ immunohistochemistry or western blot analysis.

3. A method for identifying a human at risk for developing breast cancer or prostate cancer, comprising:

contacting, in vitro, a non-cancerous breast tissue sample or a non-cancerous prostate tissue sample from the human with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting expression of ARL-1 protein in the sample based on said contacting step; and

identifying said human at risk for developing breast cancer or prostate cancer when expression of ARL-1 protein detected in the non-cancerous breast or prostate sample is greater than expression of ARL-1 protein in a normal breast tissue sample or prostate tissue sample.

4. A method of claim 3 , wherein expression of the ARL-1 protein is detected by in situ immunohistochemistry or western blot analysis.

5. A method for identifying a human at risk for recurrence of breast cancer or prostate cancer, comprising:

contacting, in vitro, a breast tissue sample or a prostate tissue sample from a human who is in remission of breast cancer or prostate cancer with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting expression of ARL-1 protein in the sample based on said contacting step;

identifying said human at risk for recurrence of breast cancer or prostate cancer when expression of ARL-1 protein in said breast or prostate tissue sample is greater than expression of ARL-1 protein a normal breast or prostate tissue sample.

6. The method of claim 5 , wherein the expression of the ARL-1 protein is detected by in situ immunohistochemistry or western blot analysis.

7. A method for diagnosing cancer or a precancerous lesion thereof in a human, wherein the cancer is breast cancer, lung cancer, liver cancer, or prostate cancer, comprising:

contacting, in vitro, a bodily fluid sample from a human with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting amounts or concentrations of ARL-1 protein in the sample based on said contacting step; and

diagnosing the cancer or the precancerous lesion thereof in the human when the amounts or concentrations of detected ARL-1 protein is greater than the amounts or concentrations of ARL-1 protein in the sample from the normal human; and

subjecting the human to further testing to confirm the presence of the cancer or the precancerous lesion thereof in the human.

8. The method of claim 7 , wherein the bodily fluid is blood plasma, serum, lymph, urine, breast secretion, breast milk, prostate fluid or sputa.

9. The method of claim 7 , wherein the further testing comprises obtaining a tissue sample from the human for analysis, wherein the analysis comprises assaying the tissue sample to detect expression of the ARL-1 protein, wherein cancer or a precancerous lesion thereof is identified when expression of the ARL-1 protein ARL-1 expression in the tissue sample from the human is greater than expression of the ARL-1 protein in a normal tissue sample, wherein the tissue sample is a breast tissue, lung tissue, liver tissue or prostate tissue sample.

10. The method of claim 7 , wherein the amounts or concentrations of the ARL-1 protein is detected by western blot analysis, radioimmunoassay or enzyme-linked immunosorbent assay (ELISA).

11. A method for identifying cancer metastasis or cancer recurrence of breast cancer, lung cancer, liver cancer or prostate cancer, comprising

contacting, in vitro, a bodily fluid sample from a human who had primary tumor of breast, lung, liver or prostate and is in remission of the primary tumor with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting amounts or concentrations of ARL-1 protein in the sample based on said contacting step; and

identifying the cancer metastasis or recurrence when the amounts or concentrations of detected ARL-1 protein in said bodily fluid sample is greater than the amounts or concentrations of ARL-1 protein in a sample from a normal human.

12. The method of claim 11 , wherein the bodily fluid is blood plasma, serum, lymph, urine, breast secretion, breast milk, prostate fluid or sputa.

13. The method of claim 11 , wherein the cancer metastasis is breast cancer metastasis.

14. The method of claim 11 , wherein the amounts or concentrations of ARL-1 protein is detected by western blot analysis, radioimmunoassay or enzyme-linked immunosorbent assay (ELISA).

15. A method for identifying a human having cancer metastasis or at risk for cancer metastasis of breast cancer, lung cancer, liver cancer or prostate cancer, comprising:

contacting, in vitro, a bodily fluid sample from a human who had breast cancer, lung cancer, liver cancer or prostate cancer, and who is in remission of said cancer with one or more isolated antibodies or antigen-binding fragments thereof that specifically bind to human reductase-like-1 (ARL-1) protein, wherein the one or more isolated antibodies or antigen-binding fragments thereof comprise an isolated antibody produced by immunizing an animal using a peptide antigen with the amino acid sequence identified by SEQ ID NO:1, wherein the antibody is a monoclonal antibody;

detecting amounts or concentrations of ARL-1 protein in the sample based on said contacting step; and

identifying the human as having cancer metastasis or at risk for cancer metastasis when the amounts or concentrations of ARL-1 protein detected in the bodily fluid sample is greater than the amounts or concentrations of ARL-1 protein in a bodily fluid sample from a normal individual.

16. The method of claim 15 wherein the amounts or concentrations of ARL-1 protein is detected by western blot analysis, radioimmunoassay or enzyme-linked immunosorbent assay (ELISA).