January 14, 2008
RedLine
Trend: Rapid Testing Advances
The Food and Drug Administration cleared for marketing the xTag Respiratory Viral Panel manufactured by Luminex Molecular Diagnostics, Inc. The decision, issued on January 3, 2008, marks the first time FDA cleared an assay that detects and identifies 12 viruses and viral subtypes. Together, these viruses are responsible for more than 85 percent of respiratory viral infections. Within a few hours, this laboratory test provides patient results that may lead to improved diagnosis and more appropriate use of antibiotics.
First rapid test for malaria, manufactured by Binax, Inc., was cleared for marketing on June 4, 2007. Results detecting the circulating Plasmodium falciparum antigen become available 15 minutes after drops of whole blood are placed on a dipstick. Death from malaria, if the infection is diagnosed and treated early, may be prevented. The World Health Organization estimates that 1 million people die of malaria each year.
Verax Biomedical, Inc. received authorization to market its rapid test, Platelet PGD® Test System, to detect bacterial contaminants in blood platelets. Bacterial contaminants in blood may lead to lethal infections in transfusion medicine. The FDA approved this device in September 2007.
A rapid test to detect the presence of viral meningitis is intended to assist physicians in treating patients more promptly. Test results are available within 2.5 hours instead of the typical week needed for traditional diagnostic tests for meningitis. The Xpert EV test, manufactured by Cepheid, received marketing approval from the FDA in March 2007.
With the list of first-time rapid tests expanding, notes of caution have been urged in some instances. Regarding the use of rapid tests to detect influenza A viruses, the FDA states (July 30, 2007), “Rapid tests have been shown to have moderate sensitivities when compared to traditional detection methods for influenza A and B virus strains circulating during the influenza season… Although rapid influenza tests cleared for use in the US general demonstrate a sensitivity of >60%, false negatives are likely, and may vary by age and type of specimen…”
Latest Reports In
The US Department of Defense’s Task Force on the Future of Military Health Care released its final report on December 20, 2007. The report addresses "strategic sourcing and commodity councils" and the need to use a strategic sourcing approach to make informed business decisions. Undertaking this effort is the US Army Medical Research Acquisition Activity as it procures medical research laboratory supplies and services. The report mentions that strategic sourcing councils have been recommended also for certain labor categories: nurses, radiologists and dentists.
Discovering that the aggressive pursuit of neuroscience biomarkers is lacking, the Institute of Medicine held a workshop to discuss the challenges and opportunities in identifying biomarker targets for certain disorders and conditions, such as depression, addiction, multiple sclerosis, stroke, and retinal degeneration. The workshop focused on recognizing the current state of biomarker development and the necessary resources and processes for increasing development within the next five years. Workshop proceedings were released on January 8, 2008.
Coming up… The Centers for Disease Control and Prevention requested a fast-track report from the Institute of Medicine on recommendations for research priorities for emergency preparedness and response in public health systems. The IOM is expected to identify top research priorities that, if satisfied, would result in measurable outcomes within three to five years. Following a December workshop to discuss emergency preparedness gaps and processes, the IOM anticipates issuing a letter report later this month.