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.
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 …
Thermo–Qaigen Merger Stopped, More IVDs Report Q2 Earnings
EACH TIME A MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANY reports its quarterly earnings, clinical lab executives and pathologists gain useful new perspectives as to how the COVID-19 pandemic is fueling demand for IVD instruments, tests, and lab consumables. In this round-up of the most r…
IVD Firms Report Boom in Sales of COVID-19 Instruments, Tests
Because of the COVID-19 pandemic, second quarter earnings reports were a good news/bad news situation for most of the nation’s major in vitro diagnostic (IVD) companies. The good news was that demand for COVID-19 tests meant increased sales and revenues for IVD firms selling those…
Project Santa Fe Labs Deliver Value with Tests
CEO SUMMARY: No bigger threat looms over the financial security of the nation’s clinical laboratories than healthcare’s transition from fee-for-service payment to value-based reimbursement. To navigate that transition successfully, medical labs and pathology groups will need to adopt …
Quest Acquires Two Labs, Two Other Health Firms
CEO SUMMARY: In the span of four days in September, Quest Diagnostics agreed to buy two lab companies and the lab testing service line of a third firm. In August, it purchased wellness company Provant Health, which had earlier filed a bankruptcy action. Each of these transactions helps Qu…
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Volume XXVIII, No. 10 – July 26, 2021
In the past 24 to 36 months, some labs have quietly begun using AI-powered applications that are being used to improve operational work processes, to streamline coding/billing/collections, and for analyzing digital pathology images. Also, genetic tests are growing in number and complexity, making it ever harder for labs to get paid.
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