FDA News Digest November 25, 2002 _____________________________________________________________ New Lab Test Screens Pregnant Women Quickly for Group B Strep FDA has cleared for marketing the IDI-Strep B test, which screens pregnant women for Group B Streptococcus, giving results in one hour, as opposed to standard culture methods, which take 18 to 48 hours. Group B strep is a leading cause of illness and death among newborns in the United States. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01172.html _____________________________________________________________ FDA Clears Automated Test for Diagnosing Congestive Heart Failure The NT-proBNP, the first fully automated laboratory test to help diagnose congestive heart failure, has received FDA clearance for marketing. The test can help doctors differentiate between congestive heart failure and other disorders, such as lung disease. Congestive heart failure affects as much as two percent of the U.S. population. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01173.html _____________________________________________________________ FDA Takes Action on Corn Bioengineered to Produce Pharmaceuticals Following discovery of a small amount of bioengineered corn in a Nebraska soybean field, the biotechnology company ProdiGene has agreed to strengthen controls on any bioengineered plants it grows for pharmaceutical use. Though FDA says material from the corn poses virtually no health risk, about 500,000 bushels of soybeans that mingled with the corn will be disposed of to prevent them from entering the human or animal food supply. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01174.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be December 2. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
