# US 2014/0155288 A1 · Methods for diagnosing cancer > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155288 A1 - Document ID: US20140155288A1 - Status: Published application - Kind: A1 - Application number: 14/157,288 - Filed: 2014-01-16 - Published: 2014-06-05 - Earliest claimed: 1997-11-07 - Assignees: Incyte Corporation - Applicants: Incyte Corporation - Inventors: Preeti G. LAL; Janice Au-Young; Roopa Reddy; Lynn E. Murry; Preete Mathur - Web page: https://patentgrep.com/patent/US20140155288A1 ## CPC - G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites} - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 14/00: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof - C07K 14/435: from animals; from humans - C07K 14/47: from mammals - C12N 15/625: {containing a sequence coding for a signal sequence} - C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575) - G01N 33/575: for cancer - G01N 33/57515: of the breast - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53) - C07K 2319/02: containing a signal sequence - C07K 2319/036: targeting to the medium outside of the cell, e.g. type III secretion - C07K 2319/60: containing spectroscopic/fluorescent detection, e.g. green fluorescent protein [GFP] - C07K 2319/61: containing an enzyme fusion for detection (lacZ, luciferase) - C07K 2319/71: containing domain for transcriptional activaation, e.g. VP16 - C07K 2319/80: containing a DNA binding domain, e.g. Lacl or Tet-repressor - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The invention provides cDNAs which encodes a signal peptide-containing proteins. It also provides for the use of a cDNA, protein, and antibody in the diagnosis, prognosis, treatment and evaluation of therapies for cancer. The invention further provides vectors and host cells for the production of the protein and transgenic model systems. ## Claims ### Claim at position 1 -20. (canceled) ### Claim 21 A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises: (a) providing a biological sample from the subject; (b) contacting the biological sample with a polypeptide which specifically binds to antibodies present in the biological sample, wherein the polypeptide is selected from the group consisting of: (i) a polypeptide comprising the amino acid sequence of SEQ ID NO:16, and (ii) a polypeptide having an amino acid sequence at least about 90% identical to the amino acid sequence of SEQ ID NO:16, (c) detecting the presence of bound polypeptide in the biological sample; (d) comparing the presence of bound polypeptide in the biological sample with the presence of bound polypeptide in a control sample; (e) wherein a higher presence in the biological sample as compared to the control sample is correlated with the presence of cancer. ### Claim 22 (depends on 21) The method of claim 21, wherein the subject is a human. ### Claim 23 (depends on 21) The method of claim 21, wherein the biological sample comprises body fluids, tissues, or extracts of such tissues. ### Claim 24 (depends on 21) The method of claim 21, wherein the polypeptide is labeled. ### Claim 25 (depends on 24) The method of claim 24, wherein the label is a visible or radioactive label. ### Claim 26 (depends on 24) The method of claim 24, wherein the label is selected from the group consisting of anthocyanins, green fluorescent protein (OFP), 6 glucuronidase. luciferase, Cy3, and Cy5, radioactive forms of hydrogen, radioactive forms of iodine, radioactive forms of phosphorous, and radioactive forms of sulfur. ### Claim 27 (depends on 21) The method of claim 21, wherein differences between the polypeptide encoding the signal peptide-containing protein and SEQ ID NO:16 comprise conservative amino acid substitutions. ### Claim 28 (depends on 21) The method of claim 21, wherein the signal peptide-containing protein has: (a) a G protein coupled receptor signature at S125GMQFLACISIDRYVAV; (b) three potential N-glycosylation sites at N6, N19, and N276; (c) a potential glycosaminoglycan attachment site at S148; and (d) ten potential phosphorylation sites at S25, T74, T177, S195, T223, Y269, S278, S309, S323, and S330; or (e) any combination thereof. ### Claim 29 (depends on 21) The method of claim 21, wherein the cancer is selected from the group consisting of adenocarcinomas, prostate cancer, breast cancer, renal cell cancer, stomach cancer, testicular seminoma, mucinous cystadenoma of the ovary, transitional cell carcinoma of the bladder, uterine adenosquamous carcinoma ### Claim 30 (depends on 29) The method of claim 29, wherein the cancer is breast cancer. ### Claim 31 (depends on 30) The method of claim 30, wherein the breast cancer is ductal or lobular. ### Claim 32 (depends on 21) The method of claim 21, wherein the tissue sample is from a prostrate of the subject, and a higher presence of bound polypeptide in the biological sample is indicative of the presence of adenofibromatous hyperplasia in the subject, which is a prognostic of prostate cancer. ### Claim 33 A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises: (a) providing a biological sample from the subject; (b) contacting the biological sample with an antibody which specifically binds to a signal peptide-containing protein present in the biological sample, wherein the antibody specifically binds to a polypeptide selected from the group consisting of: (i) a polypeptide comprising the amino acid sequence of SEQ ID NO:16, and (ii) a polypeptide having an amino acid sequence at least about 90% identical to the amino acid sequence of SEQ ID NO:16, (c) detecting the presence of bound antibody in the biological sample; (d) comparing the presence of bound antibody in the biological sample with the presence of bound antibody in a control sample; (e) wherein a higher presence in the biological sample as compared to the control sample is correlated with the presence of cancer. ### Claim 34 (depends on 33) The method of claim 33, wherein the antibody is polyclonal or monoclonal. ### Claim 35 (depends on 33) The method of claim 33, wherein the antibody is labeled. ### Claim 36 A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises: (a) providing a biological sample from the subject; (b) contacting the biological sample with a nucleic acid probe at least 18 nucleic acids in length and having at least 50% sequence identity with the sequence of SEQ ID NO: 17; (c) detecting the presence of a hybridization complex in the biological sample; (d) comparing the presence of hybridization complex in the biological sample with the presence of hybridization complex in a control sample; (e) wherein a higher amount of hybridization complex in the biological sample is correlated with cancer. ### Claim 37 (depends on 36) The method of claim 36, wherein the subject is a human. ### Claim 38 (depends on 36) The method of claim 36, wherein the nucleic acid is labeled. ### Claim 39 (depends on 36) The method of claim 36, wherein the hybridization technique is selected from the group consisting of membrane hybridization and polymer coated slide hybridization. ### Claim 40 (depends on 36) The method of claim 36, wherein the nucleic acid is selected from the group consisting of: (a) a nucleic acid having the sequence shown in FIG. 1A from A24 to G44; (b) a nucleic acid having the sequence shown in FIG. 1A from G159 to C182; (c) a nucleic acid having the sequence shown in FIG. 1B from G561 to A596; (d) a nucleic acid having the sequence shown in FIG. 1D from A1011 to T1046; (e) a nucleic acid having the sequence as shown in any one of SEQ ID Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24, 25, 27, 28, 29, 30, 32, 33, 34, 36, 37, 38, 39, 40, 42, 43, 45, 46, 47, 48, 50, 51, 52, 54, 55, 56, 58, 59, 61, 62, 63, 66, 67, 70, 71, 77, 78; and (f) a nucleic acid having at least 50% sequence identity to a sequence as shown in any one of SEQ ID Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24, 25, 27, 28, 29, 30, 32, 33, 34, 36, 37, 38, 39, 40, 42, 43, 45, 46, 47, 48, 50, 51, 52, 54, 55, 56, 58, 59, 61, 62, 63, 66, 67, 70, 71, 77, 78.