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Ciphergen Hires Emergo to Help Win CE Mark for Ovarian Cancer IVD

NEW YORK (GenomeWeb News) — Ciphergen has hired European international standards consulting company Emergo to help it win CE Mark clearance for its ovarian cancer in vitro diagnostic, the company said today.
 
The company said it also is preparing a clinical trial toward gaining clearance with the US Food and Drug Administration.
 
Under the agreement, Emergo will serve as a liaison with the European Ministries of Health to help Ciphergen earn Good Manufacturing Practices approval. Ciphergen said this will enable it to market the test in at least one European country in 2007.  
 
The test uses a panel of biomarkers that provide information that may help oncologists stratify risk of developing ovarian cancer. It would be used in medical triage for differentiating malignant and benign pelvic masses.
 
Financial terms of the agreement were not released.

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