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Diagnostic tests
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example, such a test may be used to confirm that a person is free from disease, or to fully diagnose a disease, including to sub-classify it regarding severity and susceptibility to treatment. Diagnostic tests help physicians make clinical decisions for patient care.
Some diagnostic tests are parts of a physical examination that require only simple tools in the hands of a skilled practitioner, and can be performed in an office environment. Some other tests require elaborate equipment used by medical technologists in clinical laboratories, or the use of a sterile operating theater environment.
Some tests require samples of tissue or body fluids to be sent off to a pathology lab for further analysis. Some simple chemical tests, such as urine pH, can be measured directly in the doctor’s office.
The validity of such test results produced in each laboratory is entirely dependent on the measures employed before, during, and after each assay. Consistency in the production of good results requires an overall program that includes quality assurance, quality control, and quality assessment.
Diagnostic tests can be classified into three categories: invasive, minimally invasive and non-invasive.
Every test that shows an association between test results and the target disease is potentially useful. If it is not on its own thought to be useful, then a combination of it with other test results and/or data can potentially lead to a post-test probability that is thought to be high enough to rule the diagnosis in or low enough to rule the diagnosis out.
Companion diagnostics have also been developed to preselect patients for specific treatments based on their own biology, where such targeted therapy may hold promise in personalized treatment of diseases such as cancer.
Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. It has become increasingly common for pharmaceutical companies to make agreements with in vitro diagnostics (IVD) manufacturers to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.
As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs.
Quantum Dots Targeting Multiplexed Bioassays
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“State of Lab Industry” Holds Surprises for All
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Abbott, CARESIDE, Bio-Reference Labs, DIANON Systems
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Point-Of-Care Chemistry Ready To Transform Labs
CEO SUMMARY: Following on the heels of our prediction about web-based test ordering/results reporting, here’s another equally revolutionary development. CARESIDE, Inc. is ready to launch a point-of-care instrument suite for routine, high-volume chemistry and hematology tests. Early peek…
New Internet Companies Target Clinical Lab Services
CEO SUMMARY: During the coming transition from proprietary PC-based to web-based lab test ordering/reporting systems, it will be Internet start-up companies that have the competitive jump over traditional LIS vendors. There are many reasons why this is true. Here is a first look at the ma…
Unilab, DIANON Systems, UroCor Report 1998 Financial Results
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“April 5, 1999 Intelligence: Late Breaking Lab News”
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IMPATH Points Pathology Toward a Winning Future
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Private Consortium Plans To Decode Human Genes
CEO SUMMARY: Five years ago, the only option for mapping was to involve the government. New advancements in technology have lowered costs so radically that now private companies are willing to use their own funds to map the human genome. This brings the day ever closer when genetics-based…
Innovative Management Ideas Theme of Laboratory War College
ONCE AGAIN, THE Executive War College on Laboratory Management promises to be the management event of the year. Scheduled for May 12-13 at the New Orleans Sheraton, the program features 26 presentations covering the latest developments inn laboratory management. As in past years, there will…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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