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MammaPrint
MammaPrint is a prognostic and predictive diagnostic test for early stage breast cancer patients that assess the risk that a tumor will metastasize to other parts of the body. It gives a binary result, high-risk or low-risk classification, and helps physicians determine whether or not a patient will benefit from chemotherapy. Women with a low risk result can safely forego chemotherapy without decreasing likelihood of disease free survival. MammaPrint is part of the personalized medicine portfolio marketed by Agendia. MammaPrint is based on the Amsterdam 70-gene breast cancer gene signature and uses formalin-fixed-paraffin-embedded (FFPE) or fresh tissue for microarray analysis. It is a laboratory developed test (LDT) which falls into the class of ''In Vitro'' Diagnostic Multivariate Index Assays (IVDMIA). MammaPrint was the first (2007) IVDMIA to be cleared by the Food and Drug Administration (FDA) in a ''De Novo'' Classification Process (Evaluation of Automatic Class III Designati ...
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Breast Cancer Classification
Breast cancer classification divides breast cancer into categories according to different schemes criteria and serving a different purpose. The major categories are the histopathological type, the grade of the tumor, the stage of the tumor, and the expression of proteins and genes. As knowledge of cancer cell biology develops these classifications are updated. The purpose of classification is to select the best treatment. The effectiveness of a specific treatment is demonstrated for a specific breast cancer (usually by randomized, controlled trials). That treatment may not be effective in a different breast cancer. Some breast cancers are aggressive and life-threatening, and must be treated with aggressive treatments that have major adverse effects. Other breast cancers are less aggressive and can be treated with less aggressive treatments, such as lumpectomy. Treatment algorithms rely on breast cancer classification to define specific subgroups that are each treated according to ...
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Prognosis
Prognosis (Greek: πρόγνωσις "fore-knowing, foreseeing") is a medical term for predicting the likely or expected development of a disease, including whether the signs and symptoms will improve or worsen (and how quickly) or remain stable over time; expectations of quality of life, such as the ability to carry out daily activities; the potential for complications and associated health issues; and the likelihood of survival (including life expectancy). A prognosis is made on the basis of the normal course of the diagnosed disease, the individual's physical and mental condition, the available treatments, and additional factors. A complete prognosis includes the expected duration, function, and description of the course of the disease, such as progressive decline, intermittent crisis, or sudden, unpredictable crisis. When applied to large statistical populations, prognostic estimates can be very accurate: for example the statement "45% of patients with severe septic shock w ...
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Estrogen Receptor Negative
Estrogen receptors (ERs) are a group of proteins found inside cells. They are receptors that are activated by the hormone estrogen (17β-estradiol). Two classes of ER exist: nuclear estrogen receptors (ERα and ERβ), which are members of the nuclear receptor family of intracellular receptors, and membrane estrogen receptors (mERs) (GPER (GPR30), ER-X, and Gq-mER), which are mostly G protein-coupled receptors. This article refers to the former (ER). Once activated by estrogen, the ER is able to translocate into the nucleus and bind to DNA to regulate the activity of different genes (i.e. it is a DNA-binding transcription factor). However, it also has additional functions independent of DNA binding. As hormone receptors for sex steroids (steroid hormone receptors), ERs, androgen receptors (ARs), and progesterone receptors (PRs) are important in sexual maturation and gestation. Proteomics There are two different forms of the estrogen receptor, usually referred to as α and β ...
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Adjuvant Chemotherapy
Adjuvant therapy, also known as adjunct therapy, adjuvant care, or augmentation therapy, is a therapy that is given in addition to the primary or initial therapy to maximize its effectiveness. The surgeries and complex treatment regimens used in cancer therapy have led the term to be used mainly to describe adjuvant cancer treatments. An example of such adjuvant therapy is the additional treatment usually given after surgery where all detectable disease has been removed, but where there remains a statistical risk of relapse due to the presence of undetected disease. If known disease is left behind following surgery, then further treatment is not technically adjuvant. An adjuvant used on its own specifically refers to an agent that improves the effect of a vaccine. Medications used to help primary medications are known as add-ons. History The term "adjuvant therapy," derived from the Latin term ''adjuvāre'', meaning "to help," was first coined by Paul Carbone and his team at the ...
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Evidence-based Medicine
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients. Background, history and definition Medicine has a long history of scientific inquiry about the prevention, diagnosis, and treatment of human disease. The concept of a controlled clinical trial was first described in 1662 by Jan Baptist van Helmont in reference to the practice of bloodletting. Wrote Van Helmont: The first published report describing the conduct and results of a controlled clinical trial was by James Lind, a Scottish naval surgeon who conducted rese ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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Expert Review Of Pharmacoeconomics & Outcomes Research
''Expert Review of Pharmacoeconomics & Outcomes Research'' is a bimonthly peer-reviewed medical journal covering all aspects of pharmacoeconomics. It was established in 2001 and is published by Informa. The editor-in-chief is A. Bottomley (European Organisation for Research and Treatment of Cancer). Abstracting and indexing The journal is abstracted and indexed in: According to the ''Journal Citation Reports'', the journal has a 2014 impact factor The impact factor (IF) or journal impact factor (JIF) of an academic journal is a scientometric index calculated by Clarivate that reflects the yearly mean number of citations of articles published in the last two years in a given journal, as i ... of 1.669. References External links * {{DEFAULTSORT:Expert Review of Pharmacoeconomics and Outcomes Research English-language journals Expert Review journals Bimonthly journals Publications established in 2001 Pharmacology journals ...
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Amsterdam
Amsterdam ( , , , lit. ''The Dam on the River Amstel'') is the Capital of the Netherlands, capital and Municipalities of the Netherlands, most populous city of the Netherlands, with The Hague being the seat of government. It has a population of 907,976 within the city proper, 1,558,755 in the City Region of Amsterdam, urban area and 2,480,394 in the Amsterdam metropolitan area, metropolitan area. Located in the Provinces of the Netherlands, Dutch province of North Holland, Amsterdam is colloquially referred to as the "Venice of the North", for its large number of canals, now designated a World Heritage Site, UNESCO World Heritage Site. Amsterdam was founded at the mouth of the Amstel River that was dammed to control flooding; the city's name derives from the Amstel dam. Originally a small fishing village in the late 12th century, Amsterdam became a major world port during the Dutch Golden Age of the 17th century, when the Netherlands was an economic powerhouse. Amsterdam is th ...
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Irvine, California
Irvine () is a Planned community, master-planned city in South Orange County, California, United States, in the Los Angeles metropolitan area. The Irvine Company started developing the area in the 1960s and the city was formally incorporated on December 28, 1971. The city had a population of 307,670 at the 2020 United States Census, 2020 census. A number of corporations, particularly in the technology and semiconductor sectors, have their national or international headquarters in Irvine. Irvine is also home to several higher education institutions including the University of California, Irvine (UCI), Concordia University Irvine, Concordia University, Irvine Valley College, the Orange County Center of the University of Southern California (USC), and campuses of California State University Fullerton (CSUF), University of La Verne, and Pepperdine University. History The Gabrieleño indigenous group inhabited Irvine about 2,000 years ago. Gaspar de Portolà, a Spanish explorer, cam ...
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Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. CLIA Program In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: * diagnosis, prevention, or treatment of disease or impairment * health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs. Per CLIA, each specific laboratory system, assay, examination is graded for level of complexit ...
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Current Procedural Terminology
The Current Procedural Terminology (CPT) code set is a procedural code set developed by the American Medical Association (AMA). It is maintained by the CPT Editorial Panel. The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. New editions are released each October, with CPT 2021 being in use since October 2021. It is available in both a standard edition and a professional edition. CPT coding is similar to ICD-10-CM coding, except that it identifies the services rendered, rather than the diagnosis on the claim. Whilst the ICD-10-PCS codes also contains procedure codes, those are only used in the inpatient setting. CPT is identified by the Centers for Medicare and Medicaid Services (CMS) as Level 1 of the Healthcare Common Procedure Coding Syste ...
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Medicaid
Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and personal care services. The main difference between the two programs is that Medicaid covers healthcare costs for people with low incomes while Medicare provides health coverage for the elderly. There are also dual health plans for people who have both Medicaid and Medicare. The Health Insurance Association of America describes Medicaid as "a government insurance program for persons of all ages whose income and resources are insufficient to pay for health care." Medicaid is the largest source of funding for medical and health-related services for people with low income in the United States, providing free health insurance to 74 million low-income and disabled people (23% of Americans) as of 2017, as well as paying for half of all U.S. births i ...
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