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JNCI Journal of the National Cancer Institute 2004 96(7):500-501; doi:10.1093/jnci/96.7.500
© 2004 by Oxford University Press
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© 2004 Oxford University Press

NEWS

A Test Before Its Time? FDA Stalls Distribution Process of Proteomic Test

Lynn Wagner

The first 150 words of the full text of this article appear below.

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.

The science behind the test, called OvaCheck, was developed by research scientists Emanuel Petricoin, Ph.D., from the U.S. Food and Drug Administration and Lance Liotta, M.D., Ph.D., of the National Institutes of Health, in conjunction with Correlogic Systems in Bethesda, Md., which owns the patent. The test uses mass spectroscopy to look for a protein pattern, or "fingerprint," in blood samples that the group reported is indicative of ovarian cancer.

Designed for women at high risk for ovarian cancer, the screening test is being hailed for . . . [Full Text of this Article]


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Related Resource

The Clinical Laboratory Improvement Amendments
J Natl Cancer Inst 2004 96: 501. [Extract] [Full Text] [PDF]



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D. F. Ransohoff
Lessons from Controversy: Ovarian Cancer Screening and Serum Proteomics
J Natl Cancer Inst, February 16, 2005; 97(4): 315 - 319.
[Abstract] [Full Text] [PDF]