Originally Published IVD Technology June 2003
INDUSTRY NEWS
Notables
Researchers from The Institute for Genomic Research (TIGR) have deciphered the genome of the Bacillus anthracis Ames strain of the bacterium that causes anthrax. Knowledge of the sequence may aid in the development of improved diagnostics. The anthrax bacterium is carried naturally in farm and other mammals. However in the past few years, it has captured much attention as a probable weapon for biowarfare and bioterrorism.
B. anthracis is a virulent strain that differs by only 11 letters from the strain used during the postal attacks that occurred throughout the United States in 2001. TIGR researchers hypothesize that B. anthracis has evolved from Bacillus cereus, a common soil bacterium. The Ames strain differs from B. cereus primarily in its two plasmids, which carry most of the genes related to the virulence and toxicity of the bug. The completed sequence should lead to follow-up studies of the biology, epidemiology, and functioning of the bacterium. More information is available on-line at http://www.tigr.org.
Photo Credit: Human Genome Project
The Center for Devices and Radiological Health is creating a proposal defining when IVD manufacturers may replace text on IVD labels with internationally harmonized symbols. The EU IVD Directive goes into effect on December 7, 2003, and IVD manufacturers in the United States may avoid printing labels in multiple languages for devices to be sold in the EU if they are able to use symbols in lieu of text.
Although FDA recognizes the advantages of using harmonized symbols for IVD manufacturers, the agency must also consider the needs of the user population in the United States. Agency officials have expressed concern over whether the symbols will communicate as clearly as text will. In its June 2001 proposition to the FDA commissioner, Bio-Rad Laboratories (Hercules, CA) argued that the use of symbols would make labels more informative and user-friendly. FDA will review this and similar proposals before coming to a firm decision.
During an FDA Professional Society IVD Roundtable in February, Carolyn Jones, JD, associate vice president, technology and regulatory affairs, at AdvaMed (Washington, DC), reported that FDA intends to recognize parts of several standards that include IVD-specific symbols. AdvaMed plans to make a template of wall charts listing these symbols available to manufacturers.
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