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.
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
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…
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
2020 Rankings of the World’s Largest IVD Corporations
IN VITRO DIAGNOSTICS (IVD) MANUFACTURING continues to be dominated by a handful of companies, all of which sell their products worldwide. As the rankings below demonstrate, for 2020, just 11 companies accounted for 82.7% of international IVD sales. The …
PacBio Beefs Up with Purchase of Omniome for $800 Million
FORWARD-LOOKING PATHOLOGISTS AND LAB ADMINISTRATORS understand that the next big game in medical laboratory testing will be assays built upon genome sequencing. They also know that several companies are racing to produce gene sequencing instruments that are faster, simpler, and less costly in order t…
BioReference Labs to Use Gestalt for Digital Pathology
ONE OF THE NATION’S LARGEST CLINICAL LABORATORIEScis moving forward with plans to expand its use of digital pathology and whole-slide imaging. On Mar. 30, it was announced that BioReference Laboratories, Inc. would move forward with Gestalt Diagnostics’ PathFlow digital pathology solu…
IVD Firms Report Strong Growth Because of COVID-19 Testing
TO NO ONE’S SURPRISE, THOSE IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS that produce molecular tests, instruments, and automation used for COVID-19 testing reported strong growth in revenue and profits during 2020. In recent weeks, these companies issued t…
Roche to Acquire GenMark, Ovation.io Raises $21.5M
Roche to Pay $1.8 Billion for GenMark THERE’S MORE CONSOLIDATION in the in vitro diagnostics (IVD) industry. It was announced on Mar. 15 that Roche Diagnostics would acquire GenMa…
Truvian Sciences Raises $105M for Near-Patient Lab Test System
DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu…
hc1, Visiun, and Viewics: Analytics Market Evolves
CEO SUMMARY: To understand any development in the marketplace, it is best to follow the money. That Roche, Quest Diagnostics, and LabCorp spent money either to purchase or partner with a lab analytics company in the past 36 months indicates that these enterprises believe acquiring or …
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Volume XXXII, No. 6 – April 21, 2025
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