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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.
Two MTs Launch New Lab In Aberdeen, North Carolina
CEO SUMMARY: Although located in the same region as two of the nation’s largest laboratory companies, newly-created Triune Laboratory, Inc., is reporting steady growth and acceptance by physicians in the community. Founded by two medical technologists and partially funded by a pathologi…
Low 2013 Molecular Rates May Bankrupt Some Labs
CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As…
Quest Sells OralDNA, HemoCue To Clear Its Decks for 2013
THIS WEEK, Quest Diagnostics Incorporated will issue its fourth quarter and full year 2012 financial report. In anticipation of this, the nation’s largest lab company has been cleaning out its closets, so to speak. With its new CEO finishing out his first eight months of service, …
Finding Lab Growth Opportunities Amid the Gloom
IN MANY WAYS, THE TRADITIONAL BUSINESS MODELS for laboratory testing services are proving deficient in the face of a swiftly-evolving healthcare system. I suspect that none of us fully understand how many laboratory organizations are already under extreme financial stress. We intuitively understand …
RDX Alters Business Plan Due to Lab Market Changes
CEO SUMMARY: Executives at Regional Diagnostic Laboratories (RDX) made a splash last May when they announced the new company’s plans to acquire hospital laboratory outreach programs, backed by a capital commitment of $250 million. Now, in recognition of swift changes in the lab test mar…
OURLab Founder Lays Out New Business Strategy
CEO SUMMARY: For OURLabs of Nashville, Tennessee, it was the host of changes in the lab testing marketplace that motivated it to go looking for a partner. Its recently-announced merger with OPKO Health, Inc., of Miami, Florida, creates opportunities for OURLab pathologists to do more in t…
Med Tech Finds “Grace” Aboard Lab of Mercy Ship
CEO SUMMARY: One intrepid medical technologist has spent almost two decades in volunteer service working in the clinical laboratories of hospital ships operated by Mercy Ships International. As the world’s largest hospital ship, the Africa Mercy contains six operating rooms, a 78-bed IC…
Unprecedented Growth Rates for Molecular Testing
CEO SUMMARY: There will be an expanding role for innovative clinical labs as healthcare moves forward on its path toward personalized medicine. However, to capitalize on this opportunity, pathology groups and clinical labs will need to beef up their information systems. They will also nee…
More IVD Consolidation as Danaher Acquires Iris
CEO SUMMARY: Danaher Corporation continues to fuel growth by continually acquiring in vitro diagnostics (IVD) companies. Its latest purchase is Iris International, which manufactures automated urine microscopy systems. Danaher also has $5 billion available that it could spend in the next …
Cleveland Clinic Lab Aims to Grow Reference Testing
CEO SUMMARY: In the national market for reference and esoteric testing, Cleveland Clinic Laboratories (CCL) is preparing to expand its presence. It has just moved into a $75 million state-of-the-art laboratory facility and wants to increase its outreach reference testing by four-fold with…
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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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