Thursday, June 03, 2010 10:34:39 AM
ABBOTT PARK, Ill., June 3 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has cleared a new diagnostic test to monitor ovarian cancer, a disease that will strike an estimated one out of every 71 women in the United States in their lifetimes. Abbott's new ARCHITECT HE4 (human epididymis protein 4) assay, the first automated test of its kind available in the United States, uses a simple blood test to aid in monitoring for the recurrence or progression of this disease....
http://www.earthtimes.org/articles/show/abbott-receives-fda-clearance-for-new-ovarian-cancer-test,1328555.shtml
Quest has a HE4 monitoring test that was approved by the FDA in 2008. So I'm not sure why Abbott's press release says that this is "the first automated test of its kind available in the United States". There must be some difference between the two tests.
Abbot submitted application to FDA in Feb 2010. The FDA approved it rather quickly.
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