Global Diagnostics
China used to be called the sleeping giant. Anyone who follows the IVD space knows that the giant has awoken and is climbing down the beanstalk, hungry for market share. China is gradually becoming a competitive force and evolving into the world’s fastest growing market for both domestic and foreign IVD products. China’s total IVD market, which is valued at more than $4.5 billion, doubles every three years, and it will surpass the United States to become the world’s largest...
  HiberGene Diagnostics CEO Tony Hill As part of our new monthly series on emerging IVD companies, IVD Technology spoke with Tony Hill, CEO of HiberGene Diagnostics Ltd., a young company based in Dublin, Ireland. Hill's company has developed a rapid and highly sensitive molecular diagnostic test for bacterial meningitis, which the company hopes to introduce to the European market in Quarter 4 of this year, with a U.S. introduction a year later.   Please give us...
  Consumers worried about their risk for osteoporosis soon will have a new resource at their fingertips. By the end of Q2 2013, Crescent Diagnostics' CEO Brendan Farrell Crescent Diagnostics (Dublin) will launch its Bone Quality Test (BQT), which measures keratin levels in nail clippings as a surrogate marker for collagen, an indicator of bone quality. The consumer-to-lab kit initially will be available in Ireland and the United Kingdom, with other European markets, notably...
The ride started on September 26, 2012, with the publication by the European Commission of the proposed new EU IVD regulation. So far, nothing much has happened at the official level, but industry has had enough time to attentively read the 143-page document. This led to nascent concerns and an uneasy feeling that some elements of the proposal, if wrongly interpreted and applied, could seriously jeopardize the EU regulatory framework for IVDs that has been in place for a dozen or so years and...
  Well, it finally arrived. The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market is available on the EU website. Industry was apprehensive about the repercussions of the PIP breast-implant and metal-on-metal prosthesis scandals on the regulations. At one point, there were even rumors that the whole EU legislative system would abandon “new approach” principles in favor of a rigid pharma-like pre-market approval...
  Shopping for parts, components, services, and new technologies at the Clinical Lab Expo next week? You're in luck. Here's just a tiny sampling of what will be on display there. Isolation Miniature Valves Solenoid-operated valves use a flexible diaphragm to isolate the solenoid actuation mechanism from the fluid path. When the valve is energized, the solenoid retracts an armature that is attached to a flexible diaphragm. In a normally closed valve, this raises the diaphragm, allowing...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow. Overall...
The late Angus Maddison, an economist from the University of Groningen, compiled data that suggests China and India were the biggest economies in the world for almost all of the past 2000 years. They only lost this position during the Industrial Revolution. It now appears that China will regain its place as the world’s largest economy, overtaking the United States, sometime during the next decade.1 The IVD markets of China and India, two countries that account for approximately one-third...
Samsung Electronics Company, Ltd., a globally recognizable brand of semiconductor, telecommunication, digital media, and digital convergence technologies based in Seoul, South Korea, has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing products. Nexus, based in San Diego and founded not quite three years ago, manufactures and markets the Cardiac STATus, DECISION Point, and VYENT lines of rapid test kits that aid in the diagnosis and...