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The sample probably is the substance. For example, the Kastle–Meyer test will show either that a sample is not blood or that the sample is probably blood, but may be a less common substance. Further chemical tests are needed to prove that the substance is blood. Confirmatory tests are the tests required to confirm the analysis. Confirmatory ...
Patients in response categories 4-9 should be considered as failing to respond to treatment (disease progression). Thus, an incorrect treatment schedule or drug administration does not result in exclusion from the analysis of the response rate. Precise definitions for categories 4-9 will be protocol specific.
Reflect the stage of cancer; By determining the stage of cancer, it's possible to give a prognosis and treatment plan. [4] Screening for cancers; No screening test is wholly specific, and a high level of tumor marker can still be found in benign tumors. The only tumor marker currently used in screening is PSA (prostate-specific antigen ...
A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen, because cancer is often linked to mutation. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound because standard carcinogen assays on mice and rats are time-consuming (taking two to three years to ...
In medicine and medical statistics, the gold standard, criterion standard, [1] or reference standard [2] is the diagnostic test or benchmark that is the best available under reasonable conditions. [3] It is the test against which new tests are compared to gauge their validity, and it is used to evaluate the efficacy of treatments. [1]
The Oncotype DX® breast cancer assay is one such test used to predict the likelihood of breast cancer recurrence. This test is intended for women with early-stage (Stage I or II), node-negative, estrogen receptor -positive (ER+) invasive breast cancer who will be treated with hormone therapy .
For example, the ColoGuard test may be used to screen people over 55 years old for colorectal cancer. [57] Cancer is a longtime-scale disease with various progression steps, molecular diagnostics tools can be used for prognosis of cancer progression. For example, the OncoType Dx test by Genomic Health can estimate risk of breast cancer.
The confirmatory trial should clarify key clinical questions relevant to efficacy and/or safety clearly and definitively. The target patient population segmented for the trial is clearly outlined, understood and defined as this may influence the test sites and scientists (practitioners, specialists, etc.) involved.
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