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in vitro diagnostics

In vitro diagnostics (IVDs) are diagnostic tests that that can detect diseases, conditions, or infections. In vitro diagnostics test a sample of tissue or bodily fluids, as opposed to testing inside the body, such as:

  • Microbiological culture, which determines the presence or absence of microbes in a sample from the body, usually targeted at detecting pathogenic bacteria
  • Genetic testing
  • Blood glucose
  • Liver function tests
  • Calcium

Electrolytes in the blood, such as sodium, potassium, creatinine and urea.

In vitro tests can be classified according to the location of the sample being tested, including blood and urine tests.

Some tests are used health professional settings such as clinical laboratories, and other tests are for consumers to use at home. The expression “in vitro” comes from Latin, literally meaning “within the glass.” The name reflects the fact that historically such tests were conducted in glass vessels, such as test tubes.

Unlike other forms of medical technology, IVDs never interact directly with the human body. Their value stems from the information they provide. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique among health technologies.

In the U.S., in vitro diagnostics products are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.

The IVD industry is growing steadily due to a number factors, such as increased demand for infectious disease testing as new pathogen strains develop each year, such as in seasonal influenza and H1N1, and increased incidences of hospital-acquired infections. Other factors include aging demographics common to all developed nations and the accompanying increased incidence of chronic disease across all age cohorts of the population; advances in DNA sequencing; and growing demand from emerging markets, which are only now becoming able to pay for diagnostic devices.

Global IVD Companies Report Second Quarter 2024 Earnings

IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leade…

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2023 Ranking of the World’s Top 13 IVD Corporations

BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. Th…

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What Labs with LDTs Must Do to Comply with FDA’s LDT Rule

CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…

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July 22, 2024, Intelligence: Late-Breaking Lab News

Some hospitals failing to comply with the federal price transparency regulation have been fined. The website of CMS.gov lists 15 hospitals and the amount each was fined. On June 6, 2022, the first fines were levied against Northside Hospital of Atlanta ($883,130) and Northsid…

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Global IVD Companies Report First Quarter 2024 Earnings

IN THEIR INITIAL FINANCIAL REPORTING F…

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ACLA President Van Meter Discusses LDT Lawsuit

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…

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How Private Health Insurers May Respond to FDA LDT Regulation

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Significant Developments Are Shaping Lab Market

CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…

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FDA Hosts Webinar to Explain Key Issues with Final LDT Rule

  ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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