Article: A major breakthrough and global first in Group B Streptococcus detection in pregnant women - FDA authorizes IDI-Strep B(TM) test for commercialization on the American market.

QUEBEC CITY -- In a press release issued yesterday, the U.S. Food and Drug Administration (FDA) announced that the IDI-Strep B(TM) test has been authorized for commercialization on the American market. Designed and developed by Infectio Diagnostic Inc. (IDI) of Quebec City, Canada, this test enables health professionals to detect Group B Streptococcus in pregnant women in under an hour at the time of delivery. IDI-Strep B(TM) is also authorized for use at all other phases of pregnancy, primarily between the 35th and 37th weeks. "This is important news for the diagnostic of infectious diseases. Our IDI-Strep B(TM) assay is the first clinical diagnostic test cleared by the ...

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