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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.
NeoGenomics to Acquire Clarient for $275 Million
CEO SUMMARY: In a surprise move that further consolidates national anatomic pathology services, NeoGenomics will acquire Clarient Inc., from General Electric Healthcare. General Electric is getting cash, and preferred and common stock. The two companies announced plans to pursue integrate…
Labs Have Questions for CMS on Proposed Rule
CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…
Detroit Hospital Develops 10 Ways To Add More Value
CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has identified 10 ways that it c…
Theranos, Capital Blue Sign Lab Test Agreement
CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…
LabCorp, Sysmex Will Collaborate To Develop Liquid Biopsy Tests
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer. The collaboration call…
New MoPath Lab Coalition Takes its Case to Congress
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnosti…
March 30, 2015 Intelligence: Late Breaking Lab News
Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation system…
March 9, 2015 Intelligence: Late Breaking Lab News
Many laboratory professionals are closely watching the development of Theranos, the lab testing company based in Palo Alto, California, that claims it has technology and a business model that will disrupt the clinical laboratory testing market. Recently Forbes announced its annual li…
February 17 Intelligence: Late Breaking Lab News
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the…
Meaningful Use Stage 2 Is Problem for EHR Firms
CEO SUMMARY: EHR system vendors must now comply with the federal government’s Meaningful Use Stage 2 requirements. Well-established EHR vendors will survive. But smaller EHR companies may struggle to provide the enhancements to their first generation EHR products that are require…
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Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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