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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.
DIANON Systems, UroCor, Cytyc, Digene, McKesson HBOC, Abaton.com, Abbott
FEDERAL ATTORNEY SERVES SUBPOENA ON DIANON SYSTEMS NEWS BROKE LAST WEEK that DIANON Systems, Inc. had received a subpoena from the U.S. Attorney’s Office in Connecticut for documents relating to laboratory billing. Apparently “LabScam” is still alive …
Consumers Taking Active Role In Their Laboratory Testing
CEO SUMMARY: Two recent Internet surveys revealed that consumers rank access to their personal lab test results as the number one most wanted feature in healthcare services. This is an early warning for laboratories and pathology group practices. Today’s consumers have changing expectat…
DNA Diagnostics Market, Kaiser Permanente, TriPath Imaging, LifeScan
DNA DIAGNOSTICS MARKET GROWTH TO BE DOMINATED BY PCR TECHNOLOGY FOR THE YEAR 2000, total DNA diagnostic technology sales were estimated to be $517 million. By 2005, this number should increase to $771 million, a growth rate of 8.4% per year. This is the conclusion of Laura Roth, author of …
Business Premises Underlying Lab Industry Dynamics
This chapter addresses the characteristics of the laboratory industry which define the starting point for changes and ongoing evolution. The eight business premises listed in this White Paper describe unique situations which directly influence the ability of clinical laboratories to serve the medical…
Genetics Tidal Wave is Rapidly Approaching
EVERYONE IN THE CLINICAL LAB BUSINESS KNOWS that our business will soon be dominated by genetic and molecular testing technology. However, most lab administrators and pathologists believe that we are several years away from the widespread clinical use of such technology in laboratory testing. In pr…
Bill Bonello Sees Opportunities In Diagnostic Services Companies
CEO SUMMARY: With the clinical laboratory industry now enjoying growing interest by professional investors, THE DARK REPORT traveled to New York City to meet with financial analyst William B. Bonello, of U S Bancorp Piper Jaffray. Bonello co-authored a just-released overview of what he ca…
Dr. Bruce Friedman Identifies Market Dynamics Driving Evolution of Lab Information Services
CEO SUMMARY: Probably no one is better positioned to identify the evolution of laboratory information services than Bruce Friedman, M.D., Professor of Pathology at the University of Michigan Medical School in Ann Arbor. For almost 20 years, he has hosted the pre-eminent meeting in laborat…
Neurology is Test Focus For Athena Diagnostics
CEO SUMMARY: There are few examples of laboratory companies focused on a single medical specialty,a business model that is expected to become more common in coming years. One such company is Athena Diagnostics. For 12 years, this company has concentrated on providing diagnostic testing fo…
Express Scripts, InformInvestor.com, UroCor, Bio-Reference Laboratories
PRESCRIPTION DRUG SPENDING HITS A RECORD INCREASE OF 17.4% IN 1999 Just-released data from Express Scripts, Inc. indicates that spending on prescription drugs increased by a record 17.4% during 1999. This compares to a 9.6% spending increase for drugs in 1998. As most lab e…
Luminex Raises $83 Mil In Public Stock Offering
CEO SUMMARY: During the past year, Luminex Corporation moved swiftly to push its LabMAP™ multiplex testing technology into the bioassay marketplace. It found high interest among companies in the pharmaceutical, diagnostics, and bioresearch industries. Luminex executives say that a numbe…
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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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