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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.
Evolution in Pap Marketplace Shows Impact of New Guidelines
NEW GUIDELINES for cervical cancer screening issued last year are fueling strong growth in the sales of Digene Corporation’s HPV test. For its fiscal second quarter that ended on December 31, 2004, Digene reported sales of $27.0 million. That’s a 28% increase from Digene’s sal…
Bi-Annual Look at Trends Reshaping Clinical Labs
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Roche/Affymetrix Microarray Cleared for Clinical Use by FDA
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Change Beneath Surface Marks 2004 Lab Stories
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…
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ONCE AGAIN, THE DARK REPORT IS FIRST TO ALERT YOU to a significant development in the laboratory testing marketplace. I am referring to a new and evolving Medicare policy which calls for the agency to reimburse for expensive new medical treatments and diagnostic tests. As you will r…
Medicare Changes Policy On New Med Procedures
CEO SUMMARY: Faced with a literal tidal wave of new medical procedures, new therapeutic drugs, and new diagnostic tests, Medicare is crafting a unique strategy. As a new clinical option reaches the market, Medicare will reimburse—but only if the patient participates in a clinical study …
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“November 1, 2004 Intelligence: Late Breaking Lab News”
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IMPATH Has a Buyer: Genzyme Pays $215 Mil
CEO SUMMARY: Two unexpected things happened in IMPATH’s Chapter 11 bankruptcy action. First, it attracted a buyer willing to pay the premium price of $215 million for its assets. Second, the buyer was not another laboratory company. Rather, it is a new entrant into the oncology diagnost…
Useful Info at War College On Molecular, Lean, et al
CEO SUMMARY: When the nation’s leading laboratory administrators and pathologists gather in New Orleans on April 27- 28, they will get the best and latest developments in laboratory management. From Aetna’s National Medical Director to the former Chief of the Industry Guidance Branch …
CURRENT ISSUE
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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