CEO SUMMARY: Growing numbers of hospital labs report that higher costs of new diagnostic tests have become a new management problem. That’s because diagnostic manufacturers are developing tests around a new business model, one that calls for higher pricing based on a premise of higher clinical value. Marketing campaigns for these new assays will become
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: With the clinical laboratory industry now enjoying growing interest by professional investors, THE DARK REPORT traveled to New York City to meet with financial analyst William B. Bonello, of U S Bancorp Piper Jaffray. Bonello co-authored a just-released overview of what he calls the “diagnostic services industry.” He is bullish on the future
CEO SUMMARY: There are few examples of laboratory companies focused on a single medical specialty,a business model that is expected to become more common in coming years. One such company is Athena Diagnostics. For 12 years, this company has concentrated on providing diagnostic testing for neurology specialists. It grew steadily throughout the 1990s and is
CEO SUMMARY: Evidence accumulates that HPV testing may be an effective way to identify women at risk for cervical cancer. Both Laboratory Corporation of America and Quest Diagnostics Incorporated recently added Digene’s Hybrid Capture® II HPV test to their menu. The intent is to offer physicians a follow-up test for patients with Pap smears that
CEO SUMMARY: During the last five years, extensive consolidation among in vitro diagnostics (IVD) manufacturers has created a new class of industry giants. Their increased dominance of the IVD marketplace promises significant change to how laboratories acquire and use reagents, test kits, and new IVD instruments. Here’s how and why the IVD industry transformed itself
CEO SUMMARY: Chiron is respected for its leadership in branched DNA and viral load technologies. The company had high expectations for its diagnostics group, particularly after its purchase of Ciba Corning. But rapid consolidation of the diagnostics industry changed Chiron’s opportunity to reach the first tier of diagnostic companies. Its experience demonstrates the far-reaching impact
CEO SUMMARY: As expected, consolidation within the diagnostics industry continues. This time it is Bayer, spending $1.1 billion to acquire Chiron’s diagnostics business. Once completed, Bayer will be the fourth-largest diagnostics company in the world. Laboratory customers of both firms will see many changes during the 18 months following the merger.
ONCE AGAIN THE DIAGNOSTICS industry