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.
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…
Lab Briefs
DOJ Obtains $140 Mil. Settlement in Drug Testing Case Last Friday, the U.S. Department of Justice (DOJ) announced a settlement totaling $136,025,077 with multiple defendants accused of using illegal inducements to encourage physicians to re…
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 …
What Labs and Pathology Groups Can Expect in 2022
IN RECENT WEEKS, OUR EDITORIAL TEAM has been developing session topics and speakers for the upcoming Executive War College Presents: Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success, which happens on Nov. 2-3, 2021. It has been an eye-opening process because of …
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…
Amazon Now Interested in Home Testing Services
CEO SUMMARY: In the past year, internet retailing giant Amazon has built sizeable clinical laboratories in the United States and the United Kingdom. Now it has regulatory clearance to sell a molecular COVID-19 test to consumers for home collection. Comments made in the past month by…
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…
IVD Firms Report Robust Growth In Third Quarter Financial Reports
FOR THE BIGGER IN VITRO (IVD) COMPANIES, the third quarter (Q3) ending Sept. 30 was a time when diagnostic sales rose—molecular testing is skyrocketing, actually—while other corporate divisions continued to lag amid the COVID-19 pandemic. …
Covid-19 Pandemic May Be Creating New IVD Winners and Losers
WITH THE PANDEMIC NOW IN ITS NINTH MONTH, in vitro diagnostics (IVD) company executives and industry consultants recognize the market for clinical laboratory instruments, tests, and products is changing in fundamental ways. “Evidence accumulates that the pandemic is helping create …
CURRENT ISSUE
Volume XXVIII, No. 13 – September 27, 2021
This issue highlights the young and upcoming IVD firms that are creating a new class of such companies, dedicated to point of care and near-patient technologies. Also, artificial intelligence has made its first breakthrough into clinical care in digital pathology.
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