Zetiq Reports CE Conformity For Its Cervical Cancer Diagnostic Kit
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Zetiq Technologies Ltd. (”Zetiq”), a auxiliary of Bio-Light Ltd. (TASE: BOLT), reports that it has fulfilled the crucial requirements towards issuance a ego proclamation CE scratch of accord for its symptomatic ware for designation of cervical cancer in cytologic specimens.
The requirements fulfilled by the companionship follow with Council Directive 98/79/EEC for in vitro symptomatic checkup devices. As contribution of these requirements, the Zetiq lab has late standard an ISO 13485: 2003 security for underdeveloped and manufacture aesculapian products.
The ware for which the caller issued the CE crisscross of ossification is positioned at this arrange as an accessory symptomatic tryout towards identifying cervical cancer in cytologic specimens obtained from females undergoing cervical stain examinations by the touchstone methods.
According to Dr. Adi Elkeles, CEO of Zetiq, “The closing of the requirements towards issuance a CE scar of accord presents a pregnant tone in the festering of the accompany’s CellDetect® chopine engineering to propose symptomatic products. The incontrovertible results obtained from the clinical trials performed in the subject of cervical cancer, aboard the ontogenesis of our ware developing, enabled fulfilment of the necessary requirements. The latterly obtained ISO 13845:2003 security for our lab established another significant milepost in stretch this CE cross of compliance, pavage the way to enable the accompany to fabrication its products nether the ISO certification, and keep development extra products.”
The ego contract CE crisscross of conformism leave enable the party to tiro output and selling of this production in Europe, lock in collaborations with stellar companies and laboratories, and do prominent exfoliation clinical trials.
Source:
Zetiq Technologies Ltd.
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