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Alpha methylacyl a coenzyme racemase detectionRelated Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Antigen-antibody Binding, Specific Binding Protein Assay Or Specific Ligand-receptor Binding Assay, Involving A Micro-organism Or Cell Membrane Bound Antigen Or Cell Membrane Bound Receptor Or Cell Membrane Bound Antibody Or Microbial Lysate, Animal Cell, Tumor Cell Or Cancer CellAlpha methylacyl a coenzyme racemase detection description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070287164, Alpha methylacyl a coenzyme racemase detection. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority under 35 U.S.C. .sctn.119(e) to U.S. Provisional Patent Application No. 60/804,025, filed Jun. 6, 2006, the entirety of which is incorporated by reference herein. BIBLIOGRAPHY [0002] Complete bibliographic citations of the references referred to herein by bracketed numerals can be found in the Bibliography section, immediately preceding the claims. The references listed in the bibliography are incorporated by reference into the application in their entireties. FIELD OF THE INVENTION [0003] The invention relates to methods of and kits for diagnosing cancer and precancerous conditions and for determining prognosis in a cancer patient, and more particularly to methods of and kits for diagnosing prostate cancer and precancerous prostate condition and for determining prognosis in a prostate cancer patient. DESCRIPTION OF THE RELATED ART [0004] Prostate cancer is the most common cancer for men in the U.S. In 2005, over 232,000 men will be diagnosed with prostate cancer, and over 30,000 men will die from it. One new case occurs every 2.5 minutes and a man dies from prostate cancer every 17 minutes. After lung cancer, prostate cancer is the leading cause of cancer-related deaths among men in the U.S. [0005] Early prostate cancer usually has no symptoms and is most commonly detected through prostate cancer screening tests such as the prostate specific antigen (PSA) blood test and digital rectal exam (DRE). Both tests have their limitations. PSA is elevated in both benign and malignant prostate diseases and has only 30% specificity, so it is a non-specific test. A digital rectal examination allows a doctor to feel only the back wall of the prostate gland, any abnormalities located in the middle or front part of the gland cannot be felt. Thus, the DRE and PSA tests cannot diagnose prostate cancer; they merely indicate that further testing is needed. [0006] Biopsy remains the gold standard in the diagnosis of prostate cancer. A prostate needle biopsy is a surgical procedure in which a small sample of tissue is removed from the prostate gland and examined under the microscope by a pathologist to make a diagnosis. While biopsies are the most accurate means of detecting the presence of cancer in the prostate, it is possible to miss a significant cancer during a biopsy--or receive a false-negative result. Prostate cancer does not typically grow as one single tumor or grouping of cancer cells. Rather, prostate cancer is usually comprised of many different small tumors or cancer cell groupings in different areas of the prostate. For this reason, the exact location of these various small tumors can be difficult to pinpoint with the biopsy needles. Moreover, it is a costly and painful procedure with complications, such as bleeding, infection and urinary retention. Each year many men with persistently elevated PSA are subject to prostate biopsy. But only 30% are diagnosed with cancer on first biopsy. [2] The rest of them may have to go through repeat biopsies without finding any evidence of malignancy, but still live with anxiety. [1] [0007] Alpha methylacyl A coenzyme racemase (AMACR) is a peroxisomal and mitochondrial enzyme involved in the .beta.-oxidation of branched fatty acids. The gene encoding AMACR is over-expressed in prostate cancer. Currently, AMACR immunohistochemical staining has become a common practice in morphologically diagnosing small, morphologically ambiguous prostate cancer in biopsy specimen. AMACR is also known as P504S. [3-6] Although serum AMACR has been reported undetectable, studies have shown that AMACR protein and mRNA can be detected from urine cellular component post prostate biopsy or massage manipulation. [7, 8] However, this detection requires collecting exfoliated cancer cells by prostate biopsy or massage manipulation. A humoral immune response against AMACR in prostate cancer patients has also been reported recently. [9] [0008] The major component of the semen ejaculate volume (average 5 mL) is made up of secretions from the accessory glands. Between 0.5 and 1 ml originates from the prostate. Studies have shown that some other putative prostate cancer biomarkers (beta HCG and GSTP1) have been detected in semen ejaculate. [10, 11] [0009] In view of the foregoing, it would be desirable to provide a specific test that can identify patients who have prostate cancer or precancerous disorder and that is superior to the current non-specific screening test, i.e., the PSA test. There is also a need for a more accurate, non-invasive method of diagnosing prostate cancer. SUMMARY OF THE INVENTION [0010] The invention is intended to solve at least some of the problems noted above. A method of detecting the presence or absence of alpha methylacyl A coenzyme racemase (AMACR) is provided. [0011] In one embodiment of the method, a fluid including a secretion chosen from at least one of a prostate secretion or a secretion from an accessory glad or a cellular component of the fluid is obtained from a subject. The fluid is contacted with a reagent for detecting AMACR under conditions such that the reagent detects AMACR in the semen. The level of AMACR is determined such as by comparing it to a standard curve. [0012] The fluid can be semen or a prostate secretion or another fluid. [0013] The presence of AMACR at a level above a minimum age-appropriate threshold level can be used as an indication of a diagnosis of prostate cancer or a precancerous prostate condition in the subject. [0014] In one embodiment of the method, the method is for diagnosing prostate cancer or a precancerous prostate condition in a subject. In the method, a sample including a secretion chosen from at least one of a prostate secretion or a secretion from an accessory gland or a cellular component of the fluid from the subject is provided. A a level of alpha methylacyl A coenzyme racemase (AMACR) in the sample is detected. The level of AMACR present in the sample is used to determine whether the subject has prostate cancer or a precancerous prostate condition. [0015] The reagent used in the methods can be an antibody. The antibody is capable of forming a complex with the AMACR. The amount of complex formed can be determined and used as a measure of the presence or amount of AMACR in the semen. The amount of complex determined can be used as an indication of a diagnosis of prostate cancer, a precancerous condition, or a prognosis of prostate cancer in the subject. [0016] In one embodiment, the antibody includes a label, such as an enzyme, a radioactive label, a fluorescent label, a fluorescence emitting metal, a chemiluminescent label, a chromophoric label, a bioluminescent label, or another label known in the art. [0017] Also provided is a method for diagnosing prostate cancer or a precancerous prostate condition in a subject. In one embodiment of the method, a semen sample from the subject is provided. A level of AMACR in the sample is detected. The level of AMACR present in the sample is used to determine whether the subject has prostate cancer or a precancerous prostate condition. [0018] The level of AMACR can be detected by exposing the sample to a first antibody specific to AMACR and detecting binding of the antibody to AMACR. A second antibody specific to AMACR can be provided, as can a third antibody. At least one the second and third antibody can include a label, such as an enzyme, a radioactive label, a fluorescent label, a fluorescence emitting metal, a chemiluminescent label, a chromophoric label, a bioluminescent label, or another label known in the art. The subject can be a human subject. [0019] Kits are also provided. In one embodiment, the kit includes a positive control that reacts with a reagent for detecting AMACR and a negative control that does not react with the reagent. Continue reading about Alpha methylacyl a coenzyme racemase detection... 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