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By Tom Winnifrith | Saturday 31 January 2015
Disclosure: Financial Investigative Media Limited, which is not owned by Tom Winnifrith but by a trust for his dependants, owns shares in companies mentioned in this article. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from ShareProphets). I have no business relationship with any company whose stock is mentioned in this article.
Premaitha (NIPT) has announced that it is almost there on getting the crucial CE-mark for its IONA test. It has passed two key milestones including ISO 13485:2003 certification which 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.
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 reckons it will get the CE-mark within four weeks and says that it has opened a state of the art demonstration and training facility for prospects and customers in preparation and that commercial manufacturing has already begun.
Real bulls had been hoping for CE-mark this month. Well almost. But the progress towards commercialisation of IONA and tapping a vast market is clearly well advanced. The shares are now 21.625p in the middle.
We tipped this on the Nifty Fifty at a 15p offer. Our target for the shares remains 30p so it is a very strong hold with more news imminent.
This article first appeared on the Nifty Fifty website run by Tom Winnifrith, Steve Moore and Lucian Miers - sorry paying customers come first. To read Lucian's next shorting idea out this weekend and to catch the next value investment share tip from Tom & Steve out shortly click HERE
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