Ciphergen Biosystems(CIPH): Message Board

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Biotech / Medical : Ciphergen Biosystems(CIPH):

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To: tuck who wrote (205)	2/25/2004 1:13:47 PM
From: tuck	Read Replies (1) of 510

Correologic -- CIPH's one time partner, now an apparent competitor -- is running into the same problem that Roche and Affymetrix ran into with their AmpliChip for DNA-based diagnostic testing: the FDA thinks its product is a device. This had the affect of delaying the launch of the Amplichip into end markets (it can be used for research purposes) by a number of months and counting. The total delay there looks to be a year or more. What the FDA does here is of obvious import to CIPH. . . . >>FDA Asks Correlogic Systems for a Meeting on Marketing of its Ovarian Cancer Test By a GenomeWeb staff reporter NEW YORK, Feb. 25 (GenomeWeb News) - Steve Gutman, the director of the US Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety, has asked Correlogic Systems to discuss the marketing of the company's test for predicting ovarian cancer, GenomeWeb News has learned. In the letter to company president Peter Levine, which is dated Feb. 18, Gutman said the test is a device and may be subject to the agency's premarket review requirements. The test, called OvaCheck, was developed by Correlogic and scientists at the National Cancer Institute and the FDA, and is licensed to clinical lab giants Quest Diagnostics and LabCorp. Click here ( fda.gov ) to view a copy of the letter, which is posted on the FDA website.<< Cheers, Tuck

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