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.
2022 Ranking of the World’s Top 12 IVD Corporations
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FDA Expected to Publish Proposed LDT Rule in August
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Despite COVID-19 Losses, IVD Executives Remain Upbeat
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IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
QuidelOrtho Earns $3.3 Billion in First Year as Combined Firm
IN OUR FEBRUARY 13, 2023, ISSUE OF THE DARK REPORT, we analyzed the 2022 full-year and Q4 earnings of major IVD companies. At the time our prior issue went to press, QuidelOrtho had not yet reported its year-end results. …
Public IVD Companies Report Q4, Full-Year 2022 Earnings
YEAR-END AND Q4 EARNINGS REPORTS FROM MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANIES pointed to a welcome sign of core diagnostic business rebounding. That’s the good news for IVD firms. The bad news? All of the SARS-CoV-2 testing revenue that th…
National Lab Says It Will Help with Supply Chain Services
RECOGNIZING THAT SUPPLY CHAIN ISSUES are troublesome to some of its clinical laboratory customers, one national lab company has announced it would like to help solve those issues. In September, Quest Diagnostics issued a press release describing …
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Siemens Healthineers Plans to Streamline Product Offerings
DURING A 15-MONTH STRETCH FROM 2006-2007, Siemens Healthineers spent $14 billion to acquire three competing companies and their various technologies. Today, Siemens is preparing to sunset as many as half of its legacy instruments and assays, whic…
2022’s Top 10 Lab Stories Confirm Challenging Times
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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