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Digene, which is based in Gaithersburg, Md., has the only test approved by the Food and Drug Administration for the virus that is implicated in nearly all cervical cancer cases.
In the United Kingdom, Clarke said, 21 labs test for this marker, but only two use the test approved by U.K. regulators.
The Chagas Biovigilance Network reports current incidents of Chagas-positive blood products in the United States, as reported by labs using the screening test approved by the FDA in 2007.
MammaPrint became the first test approved by the FDA for predicting breast cancer relapse and is composed of 70 genes.
In March 2004, the OraQuick® rapid HIV antibody test became the first rapid HIV test approved by the US Food and Drug Administration for use on oral fluid specimens.
A successful case of the clinical utility of omics-derived molecular signatures is MammaPrint [ 19], a diagnostic test approved by the Food and Drug Administration for clinical use.
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The company says that it has taken steps to get its tests approved by the F.D.A.
In the last decade only about 10 proteins have been the basis for diagnostic tests approved by the F.D.A.
"The respective international federations will have to take into account reliable tests," said Bach. "This means tests approved by international authorities".
Students in vocational programs will still have to take five Regents exams or alternative tests approved by a state panel of experts.
The so-called stress tests approved by the Union are also a delicate matter for France, the world's second-biggest nuclear power producer after the United States.
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