Zetiq Reports CE Conformity For Its Cervical Cancer Diagnostic Kit

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology
Article Date: 28 Jul 2010 - 1:00 PDT

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Zetiq Technologies Ltd. ("Zetiq"), a subsidiary of Bio-Light Ltd. (TASE: BOLT), reports that it has fulfilled the essential requirements towards issuing a self declaration CE mark of conformity for its diagnostic product for identification of cervical cancer in cytological specimens.

The requirements fulfilled by the company comply with Council Directive 98/79/EEC for in vitro diagnostic medical devices. As part of these requirements, the Zetiq laboratory has recently received an ISO 13485: 2003 certificate for developing and manufacturing medical products.

The product for which the company issued the CE mark of conformity is positioned at this stage as an adjunct diagnostic test towards identifying cervical cancer in cytological specimens obtained from females undergoing cervical smear examinations by the standard methods.

According to Dr. Adi Elkeles, CEO of Zetiq, "The completion of the requirements towards issuing a CE mark of conformity presents a significant step in the maturation of the company's CellDetect® platform technology to offer diagnostic products. The positive results obtained from the clinical trials performed in the field of cervical cancer, alongside the maturation of our product development, enabled fulfillment of the essential requirements. The recently obtained ISO 13845:2003 certificate for our laboratory constituted another important milestone in reaching this CE mark of conformity, paving the way to enable the company to manufacture its products under the ISO certificate, and continue developing additional products."

The self declaration CE mark of conformity will enable the company to initiate production and marketing of this product in Europe, engage in collaborations with leading companies and laboratories, and perform large scale clinical trials.

Source:
Zetiq Technologies Ltd.

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