Final Thoughts
Insights into lab automation's future
        Andy Thomson is senior vice president, centralized diagnostics, at Roche Diagnostics Corp. (Indianapolis). He brings to this role well-developed strategic and financial skills and a demonstrated record of managing commercial operations, product lines and business integrations. He can be reached at andrew.thomson @roche.com. Ten years ago, there were two competing schools of thought for lab automation: total lab automation versus task-targeted...
Overcoming fears associated with new IVD equipment purchases
        Maxfield L. Williams is the director of policy and external affairs at COLA (Columbia, MD). He can be reached at mwilliams@cola.org.   Physician office laboratories are complex operations in part because of the state and federal regulations that govern them. The prospect of complying with such regulations can cause doctors to think twice before purchasing new IVD equipment. Since 60–70% of healthcare decisions are made using IVD...
How molecular diagnostics has responded to industry trends
        Tiffany Olson is president and chief executive officer of Roche Diagnostics Corp. (Indianapolis). She can be reached at tiffany.olson@roche.com. An article published two years ago (IVD Technology, September 2004) discussed several trends in the healthcare industry as a whole, and their influence on the evolution and growth of molecular diagnostics. Those trends are still relevant today. In the infectious diseases area, the SARS scare has been supplanted...
European economic crisis drives healthcare organization
  EUROPEAN IVD MARKET       PHOTO BY RONI RAMOS. Several events have taken place since the beginning of the 21st century that have changed the environment for marketing IVD products in Europe. On January 1, 2002, 12 of the 13 members of the European Union (Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, and The Netherlands) adopted the Euro as a common currency. In April 2004, 10 more countries (The Czech...
Ensuring accurate diagnoses: Challenges from the manufacturing floor to the exam room
  COMMENTARY     Attila T. Lorincz, PhD, (left) is the senior vice president of research and development and chief scientific officer, and Mark del Vecchio is vice president of regulatory and clinical affairs at Digene Corp. (Gaithersburg, MD). The authors can be reached at attila.lorincz@digene.com and mark.delvecchio@digene.com, respectively. Considering that an estimated 60 to 70% of healthcare decision making is based on IVD test results, IVDs represent a...
The evolution of personalized medicine
      Emily S. Winn-Deen, PhD, is vice president, strategic planning and business development, at Cepheid (Sunnyvale, CA). She can be reached at emily.winn-deen@cepheid.com. Over the past year, there has been real progress in advancing “personalized medicine” from a concept to a standard part of medical care. Convincing genotype-phenotype correlation data have been developed for a few clinical applications, and corresponding tests...
Emerging trends in lab automation and instrumentation
      David P. Herzog, PhD, is senior vice president, instrument systems division, at Diagnostic Products Corp. (Los Angeles). He can be reached at dherzog@dpconline.com. During the past 20 to 30 years, the clinical laboratory has evolved from a medical endeavor characterized by the skills of individual artisans to an efficient, professional business focused on quality, accuracy, and continuous improvement of processes. Lab automation and instrumentation have played...
Challenges in the new molecular marker business
      James R. Prudent is chief scientific officer at EraGen Biosciences Inc. (Madison, WI). He can be reached at jprudent@eragen.com. In 2005, the molecular diagnostics industry took a significant leap forward, marked by a number of major events and several companies experiencing record growth. For the first time, FDA approved two highly multiplexed molecular IVDs: the Tag-It cystic fibrosis kit by TM Bioscience (Toronto) and the AmpliChip CYP450 test by Roche...
Expiration of Core PCR Patents
      Sidebar: Challenges in the new molecular marker business On March 28, 2005, the following eight polymerase chain reaction (PCR) patents owned by Roche Molecular Diagnostics (Pleasanton, CA) expired in the United States. On the same day in 2006, the equivalent foundational PCR patents will also expire overseas. • 4,683,195—Process for amplifying, detecting, and/or cloning nucleic acid sequences. • 4,683,202—Process for amplifying...
An international effort to achieve comparability of test results
      L to R: Craig M. Jackson, PhD, is quality system procedures team leader of JCTLM Working Group 1 and is president and cofounder of Hemosaga Diagnostics Corp. (San Diego). Robert I. Wielgosz, PhD, is JCTLM secretariat and head of the chemistry section of the Bureau International des Poids et Mèsures (Sèvres, France). Willie E. May, PhD, is cochair of JCTLM Working Group 1 and director of the Chemical Science and Technology Laboratory at the National...