TAG:

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.

IVD Firms Grow During 2022, but COVID-19 Revenue Dropped

MOST MAJOR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS started strong in 2022 as their base businesses regained steam and made up for the significant falloff in COVID-19 diagnostic test revenue.  During first quarter 2022 earnings calls with invest…

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2021 Closes with Two Major Lab Industry Events

Normally, the time around Christmas and New Year passes quietly, typically without any significant developments. Such was not the case for the clinical laboratory industry in the last month of 2021 because of two announcements, each of which confirms ongoing market trends in healthcare and the lab te…

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Ortho Clinical Diagnostics to Be Acquired by Quidel

CEO SUMMARY: In an announcement released before the end of 2021, Quidel said it had signed an agreement to acquire Ortho Clinical Diagnostics (OCD) for $6 billion. Laboratories that are customers of either company should expect changes after the deal closes as Quidel moves to integr…

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IVD Companies Report Record Sales as 2021 Draws to Close

JUDGING BY THE THIRD QUARTER FINANCIAL PERFORMANCE of the major in vitro diagnostics (IVD) manufacturers, the demand for COVID-19 testing continues to generate a substantial stream of revenue.  During their respective conference calls with investo…

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Congress May Soon Act on LDT, IVCT Regulation

CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…

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Congress May Soon Act on IVCT, LDT Regulation

This is an excerpt of a 2,017-word article in the November 29, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …

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It’s Flu Season and COVID-19 Cases Continue

SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….

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New Lab, Pathology Trends at Executive War College 2021

CEO SUMMARY: Hundreds of lab leaders traveled to San Antonio last week for the 27th annual Executive War College on Laboratory and Pathology Management. After almost two years of virtual conference and meetings using Zoom, attendees were ready to gather for a live event, complete with speakers,…

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CLIA Lab Director Testimony Shows Risks to Pathologists

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…

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Post-COVID: Repurposing Excess PCR Instruments

CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…

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