DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At
In Vitro DiagnosticsSkip to articles
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
- 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.
CEO SUMMARY: In Ireland, the big story in healthcare at the moment is the discovery that the nation’s cervical cancer screening program has failed hundreds of women who had pre-cancerous conditions or cervical cancer, but, as alleged in numerous court cases, their tests were inaccurate or the results not communicated to their physicians, or both.
CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers are slow to accept this diagnostic technology, despite its demonstrated clinical benefit
THIS MAY BE A FIRST IN LABORATORY TEST SALES AND MARKETING! Mickey Mouse will star in a new children’s book designed to educate children and parents about diagnosis and management of allergies.
This unique marketing campaign is the brainchild of Siemens Healthcare and Walt Disney Corporation. The book is called Mickey and the Giant Kachoo! It
CEO SUMMARY: It will be no surprise to lab directors and pathologists that Kalorama Information, in its latest report on point-of-care (POC) testing, estimates that glucose testing comprises 67% of this market segment. What is notable is Kalorama’s prediction that worldwide POC testing will grow by 30% during the next four years. Because of new
CEO SUMMARY: One of the hottest market segments in in vitro diagnostics (IVD) is rapid testing. However, because labs now often have multiple choices when selecting a rapid test, IVD manufacturers recognize the need to differentiate their products by adding additional features and benefits. In the case of 3M’s new rapid test for influenza, the
CEO SUMMARY: In just 15 months, Siemens AG has pulled out its checkbook three times to spend more than $14 billion to acquire major in vitro diagnostics (IVD) companies. When it closes the purchase of Dade Behring, Siemens will be in the first rank of global IVD manufacturers. It has also declared that it is
CEO SUMMARY: Biggest deal in recent weeks was the $1.55 billion Beckman Coulter paid to acquire BioSite and its Triage BNP test. But the most interesting news may be the entry of 3M Corporation into clinical diagnostics, based on its acquisition of Acolyte Biomedica Ltd., a company which offers a five-hour rapid culture-based MRSA test.
CEO SUMMARY: PerkinElmer’s interest in the multiplex capabilities of Luminex’s xMap technology led to this new licensing agreement. PerkinElmer’s instrument systems played a major role in accelerating the work of the Human Genome Project. Now, besides bioresearch applications, PerkinElmer wants to look for opportunities to develop high-volume, multi-analyte assays for in vitro diagnostics.
IN RECENT MONTHS,
CEO SUMMARY: Manufacturers across the IVD industry are aggressively seeking new marketing channels to reach their laboratory customers in more productive ways. That means moving outside the traditional emphasis on the exhibit halls of laboratory professional association meetings. In the case of Abbott Laboratories’ Architour, it is a huge semi-tractor trailer rig that brings its