Tag: in vitro diagnostics

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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.

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 the Clinical Lab 2.0 model. Member labs of Project Santa Fe are themselves working to develop and

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FDA Issues Response to Draft Legislation to Regulate LDTs

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

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access

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Top 10 Lab Stories of 2017 Dominated by Part B Cuts

CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test prices aggressively, effective Jan. 1. For the anatomic pathology sector

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Finally, Abbott Buys Alere to Become #1 in POCT

CEO SUMMARY: After nearly two years of legal battles, Abbott Laboratories’ acquisition of Alere concluded on Oct. 3. Despite antitrust requirements to divest several of Alere’s diagnostic businesses to Quidel and Siemens Healthineers, the merger makes Abbott the world’s largest provider of point-of-care testing systems. Hospitals and clinical laboratories buying POC products from Abbott and

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Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis

This is an excerpt from a 1,400-word article in the April 24, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone

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