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Premaitha Health PLC
(“Premaitha” or the “Company”)

Publication of scientific paper on Premaitha’s IONA® test

Manchester, UK – 16 February 2017: Premaitha Health, developer of a leading CE-marked non-invasive prenatal screening system, is pleased to announce the publication of “The IONA® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform” in Fetal Diagnosis and Therapy.

The paper concludes that the accuracy, robustness and speed of non-invasive prenatal testing (“NIPT”) will result in a positive clinical impact by significantly reducing the number of unnecessary invasive procedures and associated miscarriages, stress, and anxiety of expectant women.

Premaitha’s IONA® test has been developed to provide a simple-to-use, CE-marked, automated workflow comprising instrumentation and analysis software to allow it to be adopted by standard screening laboratories.
 
The paper outlines how the IONA® test has been established as a robust, automated, CE-IVD test that uses the Ion Proton next generation DNA sequencing platform from ThermoFisher, in a rapid turnaround time of just three days. The software algorithm has been developed, verified and validated on more than 350 samples showing 100% sensitivity and specificity, and a sample failure rate of <0.03%.

Dr William Denman, Chief Medical Officer, of Premaitha Health, commented: “We at Premaitha are seeing the benefits of the IONA® test in practice and are pleased with the accomplishments and achievements of the entire team. The current publication shows the attention to detail, depth of expertise and commitment to improved access and care for pregnant women and their healthcare providers brought to bear on challenging opportunities by Premaitha.”

The article is available with open access:

The IONA ® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform
Crea, F, Forman, M, Hulme, R, Old, RW, Ryan, D, Mazey, R and Risley, M.
https://www.karger.com/Article/FullText/455025

For more information, please contact:

Premaitha Health PLC    
Jo Cross, Head of Marketing    
This email address is being protected from spambots. You need JavaScript enabled to view it. 
Tel: +44 (0) 161 667 6865

About Premaitha
Premaitha is a molecular diagnostics company which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved non-invasive screening tests for pregnant women.

Premaitha’s lead test – the IONA® test – was launched in February 2015 and is the leading CE marked complete system which estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions. The IONA® test is performed on a maternal blood sample - which contains traces of fetal DNA - and then analysed using next generation DNA sequencing technology from ThermoFisher Scientific.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary stressful and invasive follow up diagnostic procedures which are costly, resource intensive and carry a risk of miscarriage.

Non-invasive prenatal screening is an emerging, multi-billion dollar global market and Premaitha’s complete CE Marked system enables laboratories and health care practitioners to offer an approved, non-invasive prenatal screening system in-house.  

Premaitha is based in Manchester Science Park, United Kingdom and its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.

  • 26 May 2017 - Premaitha completes IONA test validation on Thermo Fisher’s Ion S5 instrument +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)
     
    Premaitha completes IONA test validation on Thermo Fisher’s Ion S5 instrument
     
    Manchester, UK – 26 May 2017: Premaitha Health plc (AIM: NIPT, “Premaitha” or the “Company”), a leading international molecular diagnostics group focused on prenatal testing, announces that the IONA ® test, the Company’s CE-IVD non-invasive prenatal test (“NIPT”), has been validated for use on Thermo Fisher Scientific’s Ion S5 range of instruments.
     
    The validation
    Read More
  • 19 May 2017 - Premaitha welcomes NIPT recommendation in France +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)
     
    Premaitha welcomes NIPT recommendation in France
     
    Haute Authorité de Santé recommends introduction of NIPT for high and intermediate risk women
     
    Manchester, UK – 19 May 2017: Premaitha Health plc (AIM: NIPT, “Premaitha” or the “Company”), a leading international molecular diagnostics group focused on prenatal testing, welcomes the recommendation by the Haute Authorité de Santé (“HAS”), the French National Authority for Health, to make non-invasive prenatal
    Read More
  • 12 May 2017 - Update Re. Swiss Customer +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    Update Re. Swiss Customer

    Manchester, UK – 12 May 2017: Premaitha Health plc (AIM: NIPT, “Premaitha” or the “Company”), a leading international molecular diagnostics group focused on prenatal testing, announces that the Company’s application for its Swiss customer, Genoma SA (“Genoma”), to be placed into bankruptcy for non-payment of debts has been successful (the “Ruling”).

    As previously announced in the Company’s interim results (see RNS announcement on 21

    Read More
  • 13 March 2017 - Premaitha Raises Awareness of the IONA® Test at Key International Medical Events +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    Premaitha Raises Awareness of the IONA ® Test at Key International Medical Events

    Manchester, UK – 13 March 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on prenatal testing, will be attending a series of key international fetal medicine and OB/GYN events during March to broaden awareness of the IONA ® test. The events will include:

    The Royal College of Obstetricians and Gynaecologists

    Read More
  • 27 February 2017 - Completion of Yourgene Acquisition, Issue of Shares and Director Appointments +

    Premaitha Health PLC
    (“Premaitha” or the “Company” or the “Group”)

    Completion of Yourgene Acquisition, Issue of Shares and Director Appointments

    Manchester, UK – 27 February 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on prenatal testing, announces regulatory clearance for the completion of the acquisition of Yourgene Bioscience Co., Ltd (“Yourgene”).

    The acquisition of Yourgene, announced on 21 December 2016, has now received regulatory clearance as required by Taiwanese law. 

    Read More
  • 20 February 2017 - Middle East Business Update +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    Middle East Business Update

    Manchester, UK – 20 February 2017: Premaitha Health PLC (AIM: NIPT), developer of a leading CE-marked non-invasive prenatal screening system, is pleased to announce significant commercial progress in the Middle East through its distribution network.

    Premaitha has appointed distributors across the Middle East and these partners have signed a number of new Middle Eastern customers which in aggregate are expected to generate over 10,000

    Read More
  • 16 February 2017 - Publication of scientific paper on Premaitha’s IONA® test +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    Publication of scientific paper on Premaitha’s IONA ® test

    Manchester, UK – 16 February 2017 : Premaitha Health, developer of a leading CE-marked non-invasive prenatal screening system, is pleased to announce the publication of “ The IONA® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform ” in Fetal Diagnosis and Therapy.

    The paper

    Read More
  • 15 February 2017 - Issue of Equity +

    Premaitha Health plc
    ("Premaitha" or the "Company")

    Issue of Equity

    Manchester, UK - 15 February 2017: Premaitha Health plc (AIM: NIPT), developer of a leading CE-marked non-invasive prenatal screening system, announces that it has agreed to issue to Harwood Capital ("Harwood") 17,000,000 new ordinary shares of 0.1 pence per share, subject to admission to AIM, raising £1,487,500 at a price of 8.75 pence per share. Following the allotment of the shares, Harwood's holding will represent 6.9%

    Read More
  • 13 February 2017 - New partnership with major European diagnostics group +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    New partnership with major European diagnostics group

    Manchester, UK – 13 February 2017: Premaitha Health PLC (AIM: NIPT), developer of a leading CE-marked non-invasive prenatal screening system, announces a partnership with a major international diagnostics services group to implement the IONA ® test in at least two laboratories.

    Premaitha, through its distribution network, has secured a four-year Master Procurement Agreement (the “MPA”) with a major European diagnostics services

    Read More
  • 7 February 2017 - Southern Europe Business Update +

    Premaitha Health PLC
    (“Premaitha” or the “Company”)

    Southern Europe Business Update

    Manchester, UK – 7 February 2017: Premaitha Health PLC (AIM: NIPT), developer of a leading CE-marked non-invasive prenatal screening system, announces a number of new customers through its distribution network in Southern Europe.

    Italy
    Premaitha’s Italian distributor has won a public hospital tender to implement the first public non-invasive prenatal testing (“NIPT”) programme in southern Italy. The hospital will act as a regional hub

    Read More
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Investor Relations
Ben Simons / Fiona Henson
Vigo Communications
180 Piccadilly
London W1J 9HF
premaitha@vigocomms.com
T : +44 (0) 20 7830 9700

Public Relations
Sophie Burness / Ellie Scott
Kindred Agency
4th Floor, Dean Bradley House
52 Horseferry Road
London SW1P 2AF
IONAcampaigns@kindredagency.com
T : +44 (0) 20 7830 9700

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