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- Title
'Omic diagnostics trip up on way to clinic.
- Authors
Branca, Malorye A.
- Abstract
The article reports that the U.S. Food and Drug Administration (FDA) is taking a hard look at gene and protein expression-based tests. Perhaps harder than some developers had hoped, after another kind of "omic test," based on genetic variation, first received approval in late 2004. For now, diagnostics companies developing expression-based tests are expected to follow the same regulatory pathway, even though they have yet to prove those tests are dependable enough to be used as clinical diagnostics. Chip-based expression tests should be able to follow the same path to market as variation tests have taken.
- Subjects
UNITED States; MEDICAL function tests; UNITED States. Food &; Drug Administration; DIAGNOSIS; PROTEINS; CLINICAL medicine; GENETIC regulation
- Publication
Nature Biotechnology, 2005, Vol 23, Issue 7, p769
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0705-769