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.
Most IVD Firms Increase Q3 2023 Base Business Revenue
By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
IVD and Lab Consolidation Reduces Choices for Labs
By Robert Michel | From the Volume XXX, No. 13 – September 11, 2023 Issue
CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…
IVD Companies Launch New Assays, Analyzers, Automation
By Donna Marie Pocius | From the Volume XXX, No. 12 – August 21, 2023 Issue
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
2022 Ranking of the World’s Top 12 IVD Corporations
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
WHILE THE TOP FOUR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS kept their collective hold on the market compared to 2021, the big surprise was that Thermo Fisher Scientific’s…
FDA Expected to Publish Proposed LDT Rule in August
By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
Despite COVID-19 Losses, IVD Executives Remain Upbeat
By Donna Marie Pocius | From the Volume XXX, No. 8 – May 30, 2023 Issue
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
IVD Firms Prepare for OTC, Home Test Market Expansion
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
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
By Robert Michel | From the Volume XXX No. 4 – March 6, 2023 Issue
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
By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue
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…
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