Mesomark Assay
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Mesomark Assay
The Mesomark Assay is an '' in vitro'' test to monitor and possibly diagnose pleural mesothelioma and peritoneal mesothelioma. Developed by Fujirebio Diagnostics and approved in late January 2007 by the U.S. Food and Drug Administration (FDA), it works by measuring levels of soluble mesothelin-related proteins (SMRPs) released by diseased mesothelioma cells. The SMRP levels correlate directly with tumor volume thus permitting less invasive monitoring and improved assessment of treatment response. The MESOMARK assay is the most well-known and the world's first blood serum-based test for diagnosing mesothelioma. However, as certain types of tumors (such as sarcomatoid mesothelioma) do not release SMRP, the FDA recommends that doctors use the MESOMARK assay in conjunction with other tests to ensure an accurate mesothelioma diagnosis. In the future, the test may be used as an early detection measure as evidenced by recently sponsored tests by the Early Detection Research Network { ...
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In Vitro
''In vitro'' (meaning in glass, or ''in the glass'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called "test-tube experiments", these studies in biology and its subdisciplines are traditionally done in labware such as test tubes, flasks, Petri dishes, and microtiter plates. Studies conducted using components of an organism that have been isolated from their usual biological surroundings permit a more detailed or more convenient analysis than can be done with whole organisms; however, results obtained from ''in vitro'' experiments may not fully or accurately predict the effects on a whole organism. In contrast to ''in vitro'' experiments, ''in vivo'' studies are those conducted in living organisms, including humans, and whole plants. Definition ''In vitro'' ( la, in glass; often not italicized in English usage) studies are conducted using components of an organism that have been isolated fro ...
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Pleural
The pleural cavity, pleural space, or interpleural space is the potential space between the pleurae of the pleural sac that surrounds each lung. A small amount of serous pleural fluid is maintained in the pleural cavity to enable lubrication between the membranes, and also to create a pressure gradient. The serous membrane that covers the surface of the lung is the visceral pleura and is separated from the outer membrane the parietal pleura by just the film of pleural fluid in the pleural cavity. The visceral pleura follows the fissures of the lung and the root of the lung structures. The parietal pleura is attached to the mediastinum, the upper surface of the diaphragm, and to the inside of the ribcage. Structure In humans, the left and right lungs are completely separated by the mediastinum, and there is no communication between their pleural cavities. Therefore, in cases of a unilateral pneumothorax, the contralateral lung will remain functioning normally unless there is a ...
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Mesothelioma
Mesothelioma is a type of cancer that develops from the thin layer of tissue that covers many of the internal organs (known as the mesothelium). The most common area affected is the lining of the lungs and chest wall. Less commonly the lining of the abdomen and rarely the sac surrounding the heart, or the sac surrounding the testis may be affected. Signs and symptoms of mesothelioma may include shortness of breath due to fluid around the lung, a swollen abdomen, chest wall pain, cough, feeling tired, and weight loss. These symptoms typically come on slowly. More than 80% of mesothelioma cases are caused by exposure to asbestos. The greater the exposure the greater the risk. As of 2013, about 125 million people worldwide have been exposed to asbestos at work. High rates of disease occur in people who mine asbestos, produce products from asbestos, work with asbestos products, live with asbestos workers, or work in buildings containing asbestos. Asbestos exposure and the onse ...
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Fujirebio
Fujirebio is a Japanese multinational biotechnology company, founded and headquartered in Tokyo, Japan, and present locally with offices in Japan, Asia, Europe and the United States and through a large international distribution network. The company has manufacturing facilities in Japan, Europe and the United States. Fujirebio specializes in innovation, development, manufacturing, and marketing of in vitro diagnostics (IVD) testing reagents, instruments, and software for clinical diagnostics and for research use. Fujirebio is today an H.U. Group company (listed on the Tokyo Stock Exchange - TYO: 4544). History Fujirebio was founded in Tokyo, Japan in 1950 under the name Fujizoki Pharmaceutical, Co., Inc. In its early days the company developed and manufactured pharmaceutical products. The company's first IVD test was launched in 1966, a TPHA kit for syphilis testing. In 1983 the company changed name to Fujirebio Inc. Between 1998 and 2010 Fujirebio acquired several specialized ...
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Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ...
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Mesothelin
Mesothelin, also known as MSLN, is a protein that in humans is encoded by the ''MSLN'' gene. Function Mesothelin is a 40 kDa protein that is expressed in mesothelial cells. The protein was first identified by its reactivity with monoclonal antibody K1. Subsequent cloning studies showed that the mesothelin gene encodes a precursor protein that is processed to yield mesothelin which is attached to the cell membrane by a glycophosphatidylinositol linkage and a 31-kDa shed fragment named megakaryocyte-potentiating factor (MPF). Although it has been proposed that mesothelin may be involved in cell adhesion, its biological function is not known. A knockout mouse line that lacks mesothelin reproduces and develops normally. Mesothelin is over expressed in several human tumors, including mesothelioma, ovarian cancer, pancreatic adenocarcinoma, lung adenocarcinoma, and cholangiocarcinoma. Mesothelin binds MUC16 (also known as CA125), indicating that the interaction of mesothelin and MU ...
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EDRN
{{Short description, Cancer biomarker discovery project The Early Detection Research Network (EDRN) is a collaboration led by the National Cancer Institute (NCI) focused on the discovery of cancer biomarkers. The effort, started in 2000, includes both principal investigators and associate members from leading research institutions across the United States. The objectives of EDRN include: * Developing and testing promising biomarkers and technologies to obtain preliminary information to guide further testing; * Evaluating promising, analytically proven biomarkers and technologies, such as measures of accuracy, sensitivity, specificity and, when possible, as potential predictors of outcomes or surrogate endpoints for clinical trials; * Analyzing biomarkers and their expression patterns to serve as background for large, definitive validation studies; * Collaborating with academic and industrial leaders to develop high-throughput, sensitive assay methods; * Conducting early ...
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