Tag: Diagnostic tests

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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.

FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access

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Powerful Forces Are Reshaping Lab, Pathology

THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep their labs positioned to offer sophisticated and financially-sustainable

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Some Labs Performing ADLTs May See Increased Medicare Fees

MIXED IN THE BAD NEWS concerning the proposed Clinical Laboratory Fee Schedule for 2018, there is some good news regarding what the federal Centers for Medicare and Medicaid Services proposes to pay for certain advanced diagnostic tests.

After analyzing the proposed fee schedule, Quorum Consulting of San Francisco, reported, as other analysts have concluded, that CMS

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