Achieves significant milestones in preparing for CE-mark and commercial launch
Manchester, UK – 30 January 2015 – Premaitha Health plc (”Premaitha” or the “Company”, AIM: NIPT), an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal testing (NIPT) today announces 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 Organisation for Standardisation) 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, state-of-the art 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.”
Notes To Editors
About Premaitha Health
Premaitha is an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal screening (NIPT) and other applications. Premaitha’s flagship product, the IONA® test is the first non-invasive in vitro diagnostic product for prenatal screening enabling clinical laboratories to offer CE-marked NIPT in-house for the first time.
The IONA® test estimates the risk of a fetus having Down’s syndrome or other serious genetic diseases. The IONA® test has a higher detection rate and lower false positive rate than existing screening tests, giving pregnant women, their families and their doctors greater confidence in the result and reducing the need for unnecessary invasive follow-up tests and the associated anxiety and stress.
The IONA® test is a complete diagnostic system that is simple and standardised, enabling Premaitha’s clinical laboratory customers to perform the test in their own facilities. This supports Premaitha’s strategy of accelerating the broad dissemination of NIPT tests to ensure that their benefits are available to pregnant women everywhere.
Premaitha is listed on the London Stock Exchange (AIM). Its R&D, manufacturing and commercial operation is located at Manchester Science Park, UK.
For further information please visit www.premaitha.com.
Issued for and on behalf of Premaitha Health by Instinctif Partners.
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Melanie Toyne-SewellManaging Partner