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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.
iTunes Business Model For Digital Path Scans
CEO SUMMARY: If BioImagene’s CEO is to be believed, the company is ready to deliver a digital pathology system that is robust and affordable, even in settings with just two or three pathologists. One key to the BioImagene strategy is “per scan” pricing that avoids the need for upfro…
CMS Anti-Markup Rules Target In-Office Ancillaries
CEO SUMMARY: Medicare officials are again attempting to rein in what they consider to be potentially abusive forms of in-office ancillary services, including anatomic pathology. Proposed new rules published this month would clarify and perhaps expand the application of the Medicare anti-m…
July 28, 2008 “Intelligence: Late Breaking Lab News”
Last Monday, UroPath, Inc., an Arlington, Texas, company operating anatomic pathology laboratory condominium complexes in several states, disclosed its sale to HealthTronics, Inc., of Austin, Texas. Sales price was $7.75 million. UroPath’s former owners are urologi…
May 27, 2008 “Intelligence: Late Breaking Lab News”
A simple telemedicine system that incorporates cheap cell phone cameras is being developed by researchers in the United States and Brazil, according to an article in the May 15 issue of the American Chemical Society’s journal, Analytical Chemistry. The goal is to capture medical da…
PhyTest Assists Doctors With Lab Testing Revenue
CEO SUMMARY: PhyTest, Inc., created a unique business model upon its founding in 1998. It primarily specializes in handling laboratory test billing and collection services to office-based physicians. It also provides evaluation, consulting, and implementation services to help physicians i…
Hospital Lab Evolves Into A Consultative Resource
CEO SUMMARY: Every laboratory recognizes it has the knowledge and expertise to become more of a consultative resource to its referring physicians. At 248-bed J.T. Mather Hospital in Port Jefferson, New York, the laboratory director took advantage of administration’s interest in improving …
April 14, 2008 “Intelligence: Late Breaking Lab News”
Psychiatry may soon have its first set of objective clinical laboratory blood tests for mood disorders. Researchers at the Indiana University School of Medicine recently published their findings in Molecular Psychiatry. Working with 11 different genes, they described a “predictive …
Digitization of Pathology Is Making Steady Progress
CEO SUMMARY: Pathology digitization incorporates a greater scope of work-changing technologies than telepathology. It incorporates information technology, new diagnostic knowledge, and other engineering innovations to help pathologists move past glass and paper. Existing digital pathology…
Powerful Trends Reshaping Anatomic Path Profession
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
CMS Spotlights AP as It Delays Anti-Markup Rule
CEO SUMMARY: When Medicare officials postponed implementing a new anti-markup rule late last month, it did so because of questions about how the new rule will be applied. However, the Centers for Medicare & Medicaid Services (CMS) did implement an aspect of the anti-markup rule on Jan…
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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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