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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.
High Cost of New Assays Stretching Lab Budgets
CEO SUMMARY: Growing numbers of hospital labs report that higher costs of new diagnostic tests have become a new management problem. That’s because diagnostic manufacturers are developing tests around a new business model, one that calls for higher pricing based on a premise of higher c…
Dynacare, LabCorp, IMPATH, Visible Genetics, Abbott Labs
ACTIVITY AT DYNACARE HINTS AT POSSIBLE SALE, LABCORP MAY BE BUYER With Quest Diagnostics Incorporated snapping up independent lab companies right and left in recent months, the question asked by many is “Where’s Laboratory Corporation of America?” On …
DIANON Systems, United Health, Aetna, Quest Diagnostics, Orchid, AmeriPath
DIANON SYSTEMS INKS NATIONAL AGREEMENT WITH UNITEDHEALTHCARE A NEW NATIONAL AGREEMENT between DIANON Systems, Inc. and UnitedHealthcare was announced last week. The agreement allows DIANON Systems to provide pathology and genetic testing services to all the…
Beckman Coulter Positions Itself For Biotech Testing Continuum
CEO SUMMARY: Here’s a little-known side to diagnostics giant Beckman Coulter Inc. Its efforts to expand into the fields of biomedical R&D and clinical research is a strategic shift designed to give it early access to promising technology that could be introduced into the clinical di…
Certain Medicare Lab Reforms May Make It Through Congress
ONE CONSEQUENCE of the terrorist attacks on September 11 is that proposed reforms to Medicare lab reimbursement policies have assumed a lesser priority with the current Congress. Despite that fact, Congress must still address the day-to-day requirements of managing government functions. Thus, there …
Big Jump Predicted In Health Insurance Costs
CEO SUMMARY: Spiraling health costs are about to become a headline issue once again. There is widespread evidence that health insurers are seeking premium increases of 20% from the nation’s biggest employers. Aetna recently announced a second quarter 2001 operating loss of $95.9 million…
Public Labs Enjoy Boom Times As Revenues & Profits Climb
TAKEN COLLECTIVELY, second quarter earnings reports by public lab and pathology companies send a strong message: the lab industry is in the midst of a revenue and profit boom. It’s been more than a decade since every public lab and pathology company reported strong growth in both revenues and oper…
“May 21, 2001 Intelligence: Late Breaking Lab News”
As predicted in the last issue of THE DARK REPORT, Quest Diagnostics Incorporated did acquire all the remaining shares of MedPlus, Inc. which it didn’t already own. MedPlus offers a variety of clinical information products, including one to create and manage electr…
Luminex Test Technology Entering Clinical Usage
CEO SUMMARY: Multi-analyte diagnostic testing is moving closer to widespread clinical usage. During the past 12 months, several of the nation’s largest laboratory companies have begun to use Luminex Corporation’s LabMAP™ system to generate patient test results. At the same time, the…
Market Changes Lead LabCorp To Follow New Strategic Direction
CEO SUMMARY: When formed in 1995, Laboratory Corporation of America faced a financially-hostile marketplace for lab testing services. However, strategic planning retreats in 1997 and 1999 were pivotal in redirecting this billion-dollar lab behemoth toward financial stability. During 2000,…
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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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