A test before its time? FDA stalls distribution process of proteomic test.
Open Access
- 6 April 2004
- journal article
- research article
- Published by Oxford University Press (OUP) in JNCI Journal of the National Cancer Institute
- Vol. 96 (7) , 500-501
- https://doi.org/10.1093/jnci/96.7.500
Abstract
The recent controversy surrounding the clinical use of a proteomic test for the early detection of ovarian cancer has underscored the regulatory gaps for an emerging breed of laboratory tests, and it is raising questions about how best to balance the interests of patients who want access to cutting edge diagnostics with the need to ensure the efficacy and appropriate use of new technology.Keywords
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