Beyond Clinical Diagnostics
Nonclinical diagnostics for biowarfare testing
  For diagnostics manufacturers, entering into a contract with the military can be very lucrative and worthwhile; however, it is not for the faint of heart. From initial discussions to production of the final product, the process is very involved and can take years. To learn more about what a diagnostic company can expect when forging a relationship with the military or with local first-responder teams, IVD Technology editor Richard Park spoke with Matt Scullion, business development...
Assessing the future of immunoassays
A report by Kalorama Information (New York), “The Worldwide Market for In Vitro Diagnostic Tests,” concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease...
Promises and challenges of companion IVDs for oncology
Several conferences held last summer provided a basis for the notion that a relative gold rush of companion diagnostics in oncology is nearing reality. However, cancer biomarkers also present unique complexities for the lab industry, regulators, and physicians. The American Society for Clinical Oncology (ASCO) focused its 2009 meeting on the idea that a personalized medicine approach must become the standard for effective clinical oncology. Three years ago, Her-2/neu stood...
Nonclinical IVDs: Growing interest in a growing field
    In Person: Online Expanded Version         Rocky Ganske is president and CEO of Axela Inc., a life sciences company based in Toronto. He has more than 25 years of experience in the medical diagnostics and life sciences fields. He can be reached at r.ganske@axela.com. Manufacturers of human IVD technologies have been contributing their skills and knowledge more and more to the nonclinical and agricultural diagnostic markets. Turning their attention...
Field use of biological IVD detection equipment
    Beyond Clinical Diagnostics         Photo by Andrew Brookes The responsibility of quickly ascertaining the validity of bioterrorist attacks and protecting the public from such potential attacks has fallen to first responders (i.e., police, military, public health authorities). They have come to rely on IVD technologies that have been adapted from clinical settings into various field arenas and can rapidly determine the degree of hazard in...
Building veterinary biodefense diagnostics
            Pam Hullinger is the chief veterinary officer and leader of the Food and Agricultural Security Program at Lawrence Livermore National Laboratory (Livermore, CA). In 2001, she was one of approximately 300 U.S. veterinarians selected to assist the United Kingdom's rapid response to a devastating outbreak of foot-and-mouth disease. She can be reached at hullinger2@llnl.gov. When the United Kingdom suffered an outbreak of foot-and-mouth disease (...
Integrating detection and identification of biothreat agents
            The public perception of the risks and dangers of potentially imminent biothreats has changed considerably since certain events occurred in the 1990s and earlier this decade. The 1995 sarin attack in the Tokyo subway system that killed 12 people and injured more than 5000, and the 2001 anthrax scare at U.S. postal offices that killed five and infected 15 made major headlines and served as a wake-up call. However, the 2004 ricin attacks in a U.S....
Adapting point-of-care technology to nonclinical settings
          The RAMP reader and clinical test kit. Point-of-care (POC) testing has become a standard element of patient care in a wide variety of clinical applications. However, the concepts that distinguish POC technology—operation simple enough for nonlaboratory users; little or no maintenance requirement; and rapid, reliable results—mean that it can be applied equally well in many nonclinical settings. First responders, for example, when...
The role of diagnostics in bioterrorism
          Samples are loaded into the Ruggedized Advanced Pathogen Detection System to screen for potential biological warfare agents using the Critical Reagent Program polymerase chain reaction reagents. The significance of the effects of bioterrorism-associated category A agents (e.g., anthrax, plague, tularemia, and smallpox) on human health, public safety, and the economy makes the availability of rapid and accurate diagnostic testing of...
Developing biodefense IVDs is still a priority
      Researchers at the California Animal Health and Food Safety Laboratory and Lawrence Livermore National Laboratory demonstrated that the Newcastle disease virus could be detected using an environmental air sampling system, which is much less labor-intensive and time-consuming than conventional swab sampling. As anthrax scares go, this one had as benign a beginning and ending as possible in today's terror-obsessed world. A New York City musician who returned from...