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.
Lab Vendors Adjusting to Changing Sales Practices
By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue
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June 6, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue
Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possib…
Intermountain Health Merges with SCL Health
By Robert Michel | From the Volume XXIX, No. 7 – May 16, 2022 Issue
CEO SUMMARY: Mergers and acquisitions involving large integrated delivery networks (IDNs) are not only reshaping the nation’s hospital industry. These transactions also transform the way hospitals organize their clinical laboratories. Last month’s merger of Intermountain Health …
IVD Firms Grow During 2022, but COVID-19 Revenue Dropped
By Robert Michel | From the Volume XXIX, No. 7 – May 16, 2022 Issue
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…
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…
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…
IVD Companies Report Record Sales as 2021 Draws to Close
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
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…
Congress May Soon Act on LDT, IVCT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
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…
Congress May Soon Act on IVCT, LDT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
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 …
It’s Flu Season and COVID-19 Cases Continue
By R. Lewis Dark | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
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….
CURRENT ISSUE

Volume XXIX, No. 8 – June 6, 2022
More changes are coming for the clinical lab industry, including the Department of Justice’s move to hold individuals accountable for lab fraud, even after company settlements have been reached. Also, integrated delivery networks are forming new mergers to create ever-larger business entities, all of which has implications for labs.
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