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.

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…

Read More



Biggest IVD Manufacturers Report Robust Third Quarter Earnings

In a time of shrinking lab budgets and falling prices for lab tests in the United States, how are the larger in vitro diagnostic (IVD) manufacturers doing? A look at third-quarter financial reports provides useful insights as to which segments within the IVD industry are doing better than ot…

Read More



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…

Read More



Pap Test Errors in Ireland Attributed to Quest, CPL

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 …

Read More



Mass Spec Tests Struggle To Gain Insurers’ Attention

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 …

Read More



Mickey Mouse to Educate Kids About Allergy Lab Test Options

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…

Read More



New Report: POC Market Will Grow 30% by 2013

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…

Read More



Competition in Rapid Tests Means Value to Labs

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 an…

Read More



Siemens Acquires Dade, Builds IVD Powerhouse

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…

Read More



Lots of IVD Acquisitions as Buyers Spend Money

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.,…

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Powered by Americaneagle.com

Hosted by Americaneagle.com, Inc.