Editor's Page
Across the pond
      This special supplement marks the first time that IVD Technology magazine has had the opportunity to devote an entire publication to the IVD market in Europe. The last time that the European IVD market was a major editorial topic was 2003 when IVD Technology published a series of articles on the IVD Directive. The editors felt the time was right to conduct a thorough examination of the IVD market in Europe. With a 30% market share, Europe is the second-largest IVD...
New big kid on the block
      Siemens Medical Solutions (Malvern, PA) did some very serious shopping this past spring (see Industry News). Within a couple of months, Siemens spent more than $7 billion to acquire two major IVD manufacturers: Diagnostic Products Corp. (DPC; Los Angeles) and Bayer Diagnostics (Tarrytown, NY). With these acquisitions, besides becoming the second-largest developer of immunoassays overnight, Siemens has joined the ranks of the top IVD companies in the world. The...
Supreme Court speaks (not) on patent issues
      A previous editorial (May 2006) discussed the patent infringement case of Laboratory Corp. of America v. Metabolite Laboratories, recently heard by the U.S. Supreme Court, and how its outcome could affect the IVD industry. Last month, the Court dismissed the case entirely. In the original case, Metabolite had sued LabCorp for infringing its patent on a test for homocysteine level, which is used to ascertain a subject's vitamin B level. LabCorp counterargued that...
Ending misconceptions
      It wouldn't be surprising to learn that more than a few IVD manufacturers were a bit disconcerted by an article that appeared recently on the Web site of the Wall Street Journal. The article was written by Forrest, IL, physician Benjamin Brewer, MD, in which he explained that many of his patients avoid getting recommended screening tests primarily because they know very little about IVDs and do not see the benefits that IVDs can offer to their health. Unfortunately...
Clarifying patent issues
  EDITOR'S PAGE   The results of a patent infringement case that was recently argued before the U.S. Supreme Court could have a significant impact on the IVD industry and the development of diagnostic technologies. In the case, Laboratory Corp. of America (LabCorp) v. Metabolite Laboratories, Metabolite sued LabCorp for infringing its patent on a method for testing homocysteine levels, which in turn are used to correlate vitamin B levels. In rebuttal, LabCorp argued that the...
For the sake of public health
      Several months ago, President Bush announced a national strategy to prepare for a possible avian influenza pandemic. Part of that strategy has already come to fruition. In February, FDA approved a new laboratory test that is designed to diagnose strains of bird flu within four hours. Developed by the Centers for Disease Control and Prevention (CDC; Atlanta), the test will be distributed to approximately 140 labs designated as part of the Laboratory Response Network...
Stepping up in cancer testing
      This year could witness significant advances and progress in cancer testing. In an article forecasting major business trends and developments for 2006, the Wall Street Journal predicted that the discovery and validation of a greater number of cancer biomarkers could lead to “a revolution in cancer diagnosis.” One cancer researcher is quoted in the article as saying “biomarker medicine is an enormously revealing and important technique, and offers...
An emotional link
  Attaining proper reimbursement for IVDs continues to be one of the major challenges for the IVD industry. One of the primary factors contributing to this problem is the lack of recognition among policymakers about the important role of IVDs in healthcare. In addition to policymakers, many patients do not know what IVDs are and what they are used for, even though physicians routinely use them to make critical treatment decisions. Instead of being involved in knowing what tests are being...
Coming to fruition
Molecular diagnostics is the wave of the future in the IVD industry—still. Analysts and market reports support this view by projecting that the annual growth rate in molecular diagnostics will be 15–20% during the next three to five years. According to Kalorama Information (New York City), molecular diagnostics will be one of the fastest-growing segments in the IVD market. Such high expectations for molecular diagnostics are nothing new. When the Human Genome Project was completed...
Putting China in perspective
Everyone is talking about and focusing on China. No other country has been creating so much buzz regarding its growth potential and opportunities. While such hyperbole may be justified in a number of different business areas, it is less certain whether that same level of excitement is appropriate when applied to the IVD market in China. Economic reports indicate that the Chinese IVD market is still in its early stages of development. In 2004, the IVD market in China generated $840 million in...