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FDA to Revise Herpes Test Rules in the US

The Food and Drug Administration (FDA) of the United States proposes to revise rules that could make herpes virus tests cheaper and more extensively available.//

The FDA said it might change the classification of tests for herpes simplex virus types 1 and 2 to class II from class III, which would reduce the regulatory burdens associated with the tests.

The change would pave the way for companies seeking to develop and market herpes tests, and also relax the training requirements for laboratories and medical offices that offer the tests, an FDA spokesperson said.

The FDA had considered reclassifying the tests as long ago as 1980, but had said the tests posed a "potential unreasonable risk of illness or injury" at the time. With the older tests, a false positive could expose a pregnant mother or her baby to unnecessary treatment with antiviral drugs or lead to an unnecessary Caesarean delivery of the child. A false negative could result in the infection of a newborn infant, which could be fatal.

The FDA says the reliability and performance of the tests has improved now. It has set a deadline of April 10 for comments on the reclassification.

At least 45 million Americans 12 and older have genital herpes, which is generally caused by the type 2 virus, according to the Centers for Disease Control and Prevention.


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