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.
Top Public IVD Companies Report Q3/Q4 2022 Earnings
IT WAS A MIXED BAG OF THIRD QUARTER FINANCIAL RESULTS for the nation’s largest in vitro diagnostics (IVD) manufacturers, with COVID-19 testing volume a contributing factor. Fluctuating demand for SARS-CoV-2 testing proved perplexing, as some IV…
Babson Diagnostics’ Hybrid Model Combines Quality, Convenience
CEO SUMMARY: Responding to its own data about consumer preferences, healthcare technology company Babson Diagnostics is pursuing a new hybrid model for blood draws that it believes brings together the best of clinical laboratories and retail pharmacies. Laboratory managers and patho…
Reports Say Qiagen and Bio-Rad Discussing Potential IVD Merger
More consolidation in the in vitro diagnostics (IVD) market may soon happen. Bio-Rad Laboratories and Qiagen are reportedly in merger discussions. The Wall Street Journal, which broke the story on Oct. 10, tabbed the potential deal as being worth …
Thermo Fisher Expands Menu to Offset COVID-19 Decreases
IT’S NOT JUST CLINICAL LABORATORIES seeking ways to repurpose the analyzers and automation they used to perform SARS-CoV-2 testing. As the pandemic continues to ease, some in vitro diagnostics (IVD) companies want to help their lab customers by expanding the types of diagnostic tests than can …
2021 Rankings of the World’s Top 12 IVD Companies
WHILE THERE WAS SOME JOCKEYING FOR NEW positions, in vitro diagnostics (IVD) manufacturers remain entrenched in their market based on The Dark Report’s 2021 ranking of the Top 12 IVD Companies. COVID-1…
Coverage, Reimbursement Still Difficult for New Lab Tests
CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…
In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges
CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have t…
Lab Vendors Adjusting to Changing Sales Practices
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Intermountain Health Merges with SCL Health
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
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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Volume XXXII, No. 6 – April 21, 2025
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