Premaitha Health plc has announced that it has met two key requirements for obtaining a CE-mark for its IONA® test: ISO 13485:2003 certification and a successful audit of Annex IV of the In Vitro Diagnostic Medical Device Directive (98/79/EC).
The ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. The ISO 13485:2003 certification confirms that Premaitha’s quality management system has been approved as applicable to the design, development and manufacture of in vitro diagnostic reagents and associated software for non-invasive assessment of genetic abnormalities. Certification provides a framework for the award of a CE-mark for Premaitha’s IONA® test, which is now expected in February 2015.
The Company has also been audited against the requirements of Annex IV of the In Vitro Diagnostic Medical Device Directive (98/79/EC) and recommended by the Notified Body, UL International, for a European Commission (EC) certificate demonstrating full quality assurance system approval. Under the Directive this, in addition to Notified Body review of the technical documentation, will cover the requirements for placing the IONA® test on the European market as an in vitro diagnostic medical device.
Premaitha has made further operational progress in preparation for commercial launch upon award of the CE mark. The Company opened a dedicated, demonstration and training facility for prospects and customers at the end of 2014. Commercial manufacturing has also begun and the Company recently completed the development of a new warehouse facility. Both operations are located at the Company’s headquarters in Manchester, UK.
Dr Stephen Little, CEO of Premaitha, said: “We are making clear progress in achieving the CE-mark for the IONA® test and its commercial launch. The ISO certification and Annex IV approval provide evidence of the quality of our world-class operational and commercial functions, and we anticipate receipt of the CE-mark very shortly. We look forward to bringing this ground-breaking screening test to market, making it available to any pregnant woman who needs it.”