Global Diagnostics
Industry associations discuss mutually important issues
Last October, the European Diagnostic Manufacturers Association (EDMA; Brussels) hosted the European IVD Forum 2011. The primary purpose of the forum was to facilitate discussions among high-level stakeholders on the challenges faced by healthcare systems. To this end, the forum was attended by members of the IVD industry, key policymakers from European and national institutions, and representatives from patient and professional healthcare groups. According to EDMA officials, the key global...
Revision of Europe’s IVD Directive 98/79/EC
The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.1 It provides Europe with one single regulation for in vitro diagnostics (IVD). Devices receiving the CE mark after one successful conformity assessment procedure can be introduced into the member states of the European Union and the European Free Trade Association, and two countries with which mutual recognition agreements have been established (Switzerland and...
Sidebar: South Korea, an economic success story
Since the 1960s, South Korea has achieved massive growth and global integration to become a high-tech industrialized economy. Today South Korea boasts a GDP of approximately $1.459 trillion, and currently is among the world’s 20 largest economies. In 2007, the United States and South Korea signed a comprehensive free-trade agreement (FTA). It is the second-largest-ever free-trade agreement for the United States, and the United States’ first FTA with a major Asian economy. It is...
Thermo Fisher Scientific Continues Its Acquisition Trend
In a move consistent with its busy acquisition history in 2010, Thermo Fisher announced at the end of last year its plans to acquire chromatography-system manufacturer Dionex Corp. (Sunnyvale, CA). The proposed acquisition comes as the most recent in a string of acquisitions, mostly of companies integrated into Thermo Fisher’s Analytical Technologies segment. Dionex will be brought into the same group; however, unlike the other other three 2010 additions to that division, Dionex...
Cepheid earns WHO endorsement of rapid TB test
Cepheid’s Xpert MTB/RIF test won the endorsement of the World Health Organization (WHO) last December. The test has the potential to revolutionize TB care and treatment by accurately diagnosing patients in about 100 minutes—a huge reduction in time to results compared to conventional TB diagnosis, a WHO representative said in a press statement. Cepheid (Sunnyvale, CA) is offering a 75% discount on the price of the test and the table-top computer system that goes with it to...
Report: POL tests will enable more efficient diagnoses
A report issued by  Kalorama Information (New York City) characterizes the physician-office-lab (POL) testing market as “wide and diverse as one can imagine” and “an emerging tool for more efficient diagnosis and patient evaluation.” The report, “Physician Office Laboratory Markets,” published in November 2010, analyzes how the market for POL testing has evolved since 2007. It places the world market for POL diagnostics in 2009 at an estimated $2 billion...
GE Acquires Clarient: In vivo meets in vitro
GE Healthcare purchased Clarient Inc. (Aliso Viejo, CA) late last year. The acquisition was announced in October; U.S. regulators approved the transaction the following month.  GE, a well-known player in diagnostic imaging, is looking to lengthen its reach into molecular diagnostics (MDx), particularly in the oncology realm. With its acquisition of Clarient, it gains the potential for playing a large, comprehensive role in diagnosing and treating cancer. “Clarient is a clear leader...
Assessing the IVD markets of Brazil and Mexico
IVD Technology previously published an article (September 2007) on the IVD markets in Brazil and Mexico, Latin America’s two largest markets, which was written by McEvoy & Farmer (Seattle). At that time, growth was strong in both markets, and their futures looked optimistic, but no one knew that 2008 would bring a worldwide financial crisis. This article discusses how these two markets have fared during the past two years and what the future holds for them. McEvoy & Farmer has...
Report shows continued growth for India’s IVD market
A report published this summer by Kalorama Information (New York City) and McEvoy & Farmer (Seattle) points to continued strong growth in India’s clinical diagnostics market. As of 2008, the market totaled roughly $357 million, according to the report, and annual growth was about 15%. Growth in IVD market in India (1996-2008) in millions of U.S. dollars. (Click here to enlarge.) Source: Kalorama Information “This is the sixth study we have done on India’s IVD...
15th Anniversary Essay: Looking Back: A Review of International IVD Regulations
During the 1990s, IVD regulation changed dramatically, and this development has accelerated even into the new century. Regulators and the IVD industry found agreement on quality system requirements and acceptance of ISO 13485 to cover design to post-market.1 These are major achievements and should not be undermined. Worldwide, the principles of classification of IVD medical devices, labeling requirements, risk management, and even medical event reporting have also been agreed on in principle....