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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.

FDA’s Gottlieb Favors Flexibility with LDTs, NGS

CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…

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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 professio…

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A coming transformation: Control over important diagnostic technologies is about to change hands

This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: He…

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Labs Begin Applying Lean to Cut Costs, Add Value

CEO SUMMARY: In more than 40 presentations by 55 speakers, two big themes dominated the 11th annual Lab Quality Confab in New Orleans last week. One theme is the urgent need to cut clinical laboratory costs. The second theme is the need for both clinical labs and anatomic pathology groups…

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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, …

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Federal Regulation of LDTs Subject of Proposed Bill

THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…

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PAMA Fee Cuts a Factor in Outreach Lab’s Sale

THROUGHOUT THE WORLD, THE UNITED STATES IS ENVIED for the quality and ready access to medical laboratory tests that it delivers to physicians and their patients. Yes, there are criticisms that healt…

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January 30, 2017 Intelligence: Late Breaking Lab News

In New Jersey, a U.S. attorney has put laboratory sales reps on notice that they can be prosecuted for violating federal anti-kickback laws and sent to prison. On January 18, Paul Fishman, U.S. Attorney for New Jersey, announced the sentencing of Michael J. Zarrelli, of Berkeley Heights, N.J., forme…

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Can Clinical Laboratories Adjust To ‘New’ Healthcare System?

CEO SUMMARY: Month by month, there is increased clarity in the path the American healthcare system will follow as hospitals, health systems, and physicians integrate clinical care, manage populations, and practice personalized and precision medicine. While these changes play out, clinical…

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