Test name | Epidermal growth factor receptor |
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Other names | EGFR pharmDx, HER-1, Cetuximab (Erbitux) sensitivity |
Description | Dysregulation of the EGFR signaling pathway due to EGFR overexpression, genetic aberrations, or other causes leads to malignant transformation. Cetuximab inhibits binding of EGFR by EGF and transforming growth factor-α, thereby blocking downstream signal transduction pathways and arresting cell growth. |
Purpose | Diagnostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Tissue |
Methodology | IHC |
Cancers | Breast, prostate, lung, colorectal |
Other cancers | Head and neck |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics and UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | Estrogen/progesterone receptor |
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Other names | ER/PR |
Description | Breast cancers are dependent upon estrogen and/or progesterone for growth and this effect is mediated through ERs and progesterone receptors (ER/PR). Both receptors may be over-expressed in malignant breast tissue. |
Purpose | Diagnostic, prognostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Tissue |
Methodology | IHC |
Cancers | Breast |
Clinical use(s) a) Routine: |
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Source of information | UpToDate™ Web site |
Exploratory Medline search (8/2/05) |
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Test name | Fecal globin |
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Other names | InSure, FOBT |
Description | Cancerous and precancerous colorectal lesions tend to cause low-level bleeding. Annual screening with a fecal occult blood test (FOBT) can decrease colorectal cancer mortality by up to 33 percent. |
Purpose | Secondary prevention |
Availability | Commercial laboratories, academic hospitals |
Specimen | Stool |
Methodology | IHC |
Cancers | Colorectal |
Clinical use(s) a) Routine: |
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Source of information | Quest diagnostics, UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | FLT 3 mutation |
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Description | Mutations in FLT3 are common in AML and have been associated with poorer survival in children and in younger adults with normal cytogenetics receiving intensive chemotherapy. |
Purpose | Prognostic |
Availability | Quest Diagnostics |
Specimen | Blood |
Methodology | PCR |
Cancers | Acute myelogenous leukemia (AML) |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics and UpToDate™ Web sites |
Exploratory Medline search |
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Test name | HER-2/neu |
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Other names | c-erbB-2, trastuzumab (Herceptin) eligibility, HercepTest, PathVysion® |
Description | HER-2/neu is an oncogene encoding a growth factor receptor related to epidermal growth factor receptor (EGFR) and is amplified in approximately 25-30 percent of node-positive breast cancers. Overexpression of HER-2/neu is associated with decreased disease-free and overall survival. Over-expression of HER-2/neu may be used to identify patients who may be may benefit from trastuzumab (Herceptin™ ) and/or high dose chemotherapy. Trastuzumab is a humanized monoclonal antibody targeting the HER 2/neu (c-erbB-2) oncogene. |
Purpose | Diagnostic, prognostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Tumor tissue, serum |
Methodology | IHC, FISH, EIA |
Cancers | Breast |
Other cancers | HER2/neu may also be expressed in ovarian, gastric, colorectal, endometrial, lung, bladder, prostate, and salivary gland cancers. |
Clinical use(s) a) Routine: |
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Clinical use(s) b) Investigational |
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Source of information | Quest Diagnostics, LabCorp, Specialty Labs Web sites, UpToDate™ |
Exploratory Medline search (5/12/05) |
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Test name | 5-HIAA |
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Other names | 5-hydroxyindoleacetic acid |
Description | A serotonin analysis is most frequently performed for the diagnosis of carcinoid tumors of the small intestine. These tumors release large amounts of serotonin, which can produce the clinical syndrome of flushing, diarrhea, and right-sided heart failure. 5-HIAA is the final metabolite of serotonin and is the most frequently used diagnostic test for carcinoid tumors. |
Purpose | Diagnostic, prognostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Urine |
Methodology | Liquid chromatography |
Cancers | Carcinoid tumors |
Clinical use(s) a) Routine: |
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Clinical use(s) b) Investigational |
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Source of information | LabCorp, UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | Human papillomavirus hybrid capture |
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Other names | HPV, ThinPrep |
Description | Human papillomavirus (HPV) infection is a common infection that is associated with cancer. Although HPV infection does not always progress to cancer, > 93 percent of cervical cancer cases are associated with HPV. This test detects 13 viral strains that are associated with an intermediate to high risk of cancer. |
Purpose | Secondary prevention |
Availability | Commercial laboratories, academic hospitals |
Specimen | Pap smear |
Methodology | DNA probe cocktail |
Cancers | Cervical cancer |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics, UpToDate™ Web sites |
Exploratory Medline search (8/02/05) |
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Test name | IgVh mutation analysis |
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Description | Chronic lymphocytic leukemia (CLL) patients can be divided into two basic groups on the basis of the mutational status of the immunoglobulin heavy-chain variable-region (IgVH) gene in leukemic cells. Patients with IgVH mutations have longer survival than those without IgVH mutation. Thus, mutation analysis may be useful for planning management strategies. |
Purpose | Prognostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Blood, marrow |
Methodology | PCR |
Cancers | Chronic lymphocytic leukemia (CLL) |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics and UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | ImmunoCyt |
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Other names | Mucin, CEA |
Description | An immunocytochemistry assay for the detection of tumor cells shed in the urine of patients previously diagnosed with bladder cancer. This test is intended to augment the sensitivity of cytology for the detection of tumor cells in the urine of individuals previously diagnosed with bladder cancer. |
Purpose | Recurrence, monitoring |
Availability | Commercial laboratories, academic hospitals |
Specimen | Urine |
Methodology | Cytology, ICC |
Cancers | Bladder cancer |
Clinical use(s) a) Routine: |
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Source of information | LabCorp and UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | Kappa/lambda light chain |
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Description | Elevated serum levels of monoclonal free light chains are associated with malignant plasma cell proliferation (e.g., multiple myeloma), primary amyloidosis, and light chain deposition disease. The appearance of higher levels of free light chains in the urine may be indicative of kidney disease or malignant lymphoproliferative disease such as multiple myeloma. |
Purpose | Monitoring |
Availability | Commercial laboratories, academic hospitals |
Specimen | Serum, tissue, urine |
Methodology | IHC |
Cancers | Multiple myeloma, lymphoproliferative disorders |
Other cancers | Primary amyloidosis, light chain deposition disease |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics, UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | LAP |
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Other names | Leukocyte alkaline phosphatase |
Description | Low LAP scores have been associated with CML, PNH, and thrombocytopenic purpura. In CML, regardless of the total WBC, the LAP score remains low. High LAP scores have been seen in polycythemia vera, myelofibrosis, aplastic anemia, hairy cell leukemia, leukemoid reactions, and Hodgkin's disease. |
Purpose | Diagnostic, monitoring |
Availability | Commercial laboratories, academic hospitals |
Specimen | Blood, bone marrow |
Methodology | Enzyme assay |
Cancers | Chronic myelocytic leukemia (CML) |
Other cancers | Polycythemia vera, myelofibrosis, aplastic anemia, paroxysmal nocturnal hemoglobinuria, hairy cell leukemia, leukemoid reactions, lymphoma |
Clinical use(s) a) Routine: |
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Clinical use(s) b) Investigational |
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Source of information | Quest Diagnostics, UpToDate™ Web sites |
Exploratory Medline search (8/2/05) |
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Test name | Lipid associated sialic acid |
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Other names | LASA; Lipid-Bound Sialic Acid |
Description | Elevations in blood LASA levels have been reported in patients with mammary (63 percent), gastroenteric (65 percent), pulmonary (79 percent), and ovarian (94 percent) neoplasms as well as those with leukemia (86 percent), lymphoma (87 percent), melanoma (84 percent), sarcoma (97 percent), and Hodgkin disease (91 percent). As a result, this assay may not have high specificity or sensitivity necessary for cancer detection. |
Purpose | Recurrence, monitoring |
Availability | Commercial laboratories, academic hospitals |
Specimen | Serum |
Methodology | Spectrophotometry |
Cancers | Breast, lung, colorectal, pancreas, ovarian, liver, lymphoma, leukemia, melanoma, neuroblastoma, uterine, sarcoma |
Clinical use(s) b) Investigational |
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Source of information | LabCorps Web site |
Exploratory Medline search (8/2/05) |
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Test name | Melaris |
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Other names | p16 |
Description | p16 is a tumor suppressor gene that regulates cellular proliferation and growth by acting as a cyclin-dependent kinase 4 (CDK4) inhibitor. This test determines if a patient has a p16 gene mutation, indicating a predisposition for melanoma and pancreatic cancer. |
Purpose | Primary prevention |
Availability | Myriadtests.com |
Specimen | Blood |
Methodology | PCR |
Cancers | Melanoma, pancreas |
Clinical use(s) a) Routine: |
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Source of information | Myriad Tests Web site |
Exploratory Medline search (8/2/05) |
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Test name | MIB-1 antibody |
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Other names | Ki-67 antigen |
Description | There is a strong correlation between proliferation rate and clinical outcome in a variety of tumor types and measurement of cell proliferative activity is an important prognostic marker. This marker correlates with flow cytometric S-phase. |
Purpose | Prognostic |
Availability | Commercial laboratories, academic hospitals |
Specimen | Tissue |
Methodology | IHC |
Cancers | Breast, lymphomas, anaplastic large cell non-Hodgkin's lymphoma |
Clinical use(s) a) Routine: |
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Source of information | Quest Diagnostics, LabCorp, Specialty Laboratories Web sites |
Exploratory Medline search (8/02/05) |
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Test name | Micrometastasis detection |
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Other names | Cytokeratins |
Description | Cytokeratins are expressed by both normal and malignant epithelial cells, but not by lymph node or bone marrow cells. Thus, the presence of cytokeratin-positive cells in lymph nodes or the bone marrow is suggestive of metastatic tumor. Multiple chromosomal aberrations in these suspected cytokeratin-positive micrometastases further substantiate that these cells are tumor cells. |
Purpose | Recurrence, monitoring |
Availability | Commercial laboratories, academic hospitals |
Specimen | Marrow, tissue |
Methodology | IHC |
Cancers | Breast |
Clinical use(s) a) Routine: |
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Source of information | Specialty Laboratories, Quest Diagnostics Web sites |
Exploratory Medline search (8/2/05) |
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Test name | Microsatellite instability |
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Other names | MSI, BAT 26, RER+ |
Description | MSI is a marker for faulty DNA repair and is found in 90 percent of patients with hereditary non-polyposis colorectal cancer (HNPCC) but in only 15 percent of sporadic colorectal tumors. HNPCC (Lynch syndrome) is characterized by an autosomal dominant inheritance pattern of early-onset predisposition to colorectal cancer (average age 44 years). MSI is helpful in determining if colorectal cancer is due to HNPCC and whether further genetic testing of patients or their family members for HNPCC-associated mutations. |
Purpose | Primary and secondary prevention, diagnostic, prognostic |
Availability | Commercial labs, academic institutions |
Specimen | Blood, tumor tissue DNA |
Methodology | HPCR |
Cancers | Hereditary non-polyposis colorectal cancer |
Clinical use(s) b) Investigational |
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Source of information | Quest Diagnostics, LabCorp, Specialty Labs Web sites, UpToDate™ |
Exploratory Medline search (5/12/05) |
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