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Showing page 14 of 14 (133 total posts)
  • EUA: Help or Hindrance?

    This week, the FDA issued another emergency use authorization (EUA), this time allowing Focus Diagnostics to market and offer its Simplexa™ Influenza A H1N1 (2009) test for use on the 3M™ Integrated Cycler from 3M to CLIA high-complexity laboratories for the duration of the recently-declared national emergency. For new viruses and in ...
    Posted to ADVANCE Discourse: Lab (Weblog) on October 30, 2009
  • Newborn Screening Is a Big Win for Babies

    The times have caught up with the technology for newborns: All states now have laws and rules mandating the screening of all babies for a panel of serious genetic or functional disorders. All 50 states and the District of Columbia require every newborn is screened for at least 21 of the 29 disorders on the panel recommended by the American College ...
    Posted to ADVANCE Discourse: Lab (Weblog) on February 19, 2009
  • LabCorp Slammed by FDA

    The Food and Drug Administration (FDA) has notified LabCorp that it is illegally marketing a blood test to detect ovarian cancer, according to a warning letter (www.fda.gov/foi/warning_letters/s6947c.htm) posted Wednesday on the FDA's Web site. The letter states that LabCorp's OvaSure test is ''not within the scope of laboratory-developed tests ...
    Posted to ADVANCE Discourse: Lab (Weblog) on October 8, 2008