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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    
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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.

  • 12 July 2017 - Investment Agreement Extension with Thermo Fisher Scientific +

    Premaitha Health Plc
    (“Premaitha”, the “Company” or the “Group”)

    Investment Agreement Extension with Thermo Fisher Scientific

    Manchester, UK – 12 July 2017 - Premaitha Health Plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing, is pleased to announce that it has entered into a further extension of the investment agreement with Thermo Fisher Scientific (“Thermo Fisher”) announced on 14 December 2015 and extended as announced on 23 September 2016, further developing

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  • 10 July 2017 - Premaitha announces two laboratory hub contracts in South East Asia +

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

    Premaitha announces two laboratory hub contracts in South East Asia

    Manchester, UK – 10 July 2017: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), announces that it has signed contracts with two significant laboratories in South East Asia through its Taiwanese subsidiary, Yourgene Bioscience (“Yourgene”).

    The agreements have been signed with two partners for laboratories which

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  • 3 July 2017 - Litigation Update +

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

    Litigation Update

    Manchester, UK – 3 July 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), provides the following update on the legal proceedings in connection with patent infringement suits filed by Illumina, Inc. and others (together the “Claimants”). The patents in issue in these proceedings fall into three families: European Patent (UK) 0 994 963; European Patent (UK)

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  • 26 June 2017 - The IONA® test updated to include the first trimester combined test result +

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

    The IONA ® test updated to include the first trimester combined test result

    Manchester, UK – 26 June 2017: Premaitha Health, a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), is pleased to announce enhancements to the IONA ® test, which now incorporates the first trimester combined test risk score into its software.

    The IONA ® test is Premaitha’s leading CE-marked non-invasive prenatal test which

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  • 16 June 2017 - Premaitha launches Sage™ prenatal screening solution in Hong Kong +

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

    Premaitha launches Sage™ prenatal screening solution in Hong Kong

    Manchester, UK – 16 June 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), announces the launch of Sage™, an NIPT solution incorporating additional prenatal screening analysis tools.

    Sage™ is an advanced NIPT analysis solution, available through Yourgene Bioscience Singapore (“Yourgene”), which was acquired by Premaitha in March 2017. It

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  • 5 June 2017 - India Business Update +

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

    India Business Update

    Manchester, UK – 5 June 2017: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing, is pleased to provide an update on commercial progress in India.

    Yourgene Bioscience (“Yourgene”), acquired by Premaitha in March 2017, is now firmly established as one of India’s leading providers in the emerging non-invasive prenatal testing (“NIPT”) market,  with representation

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  • 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
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  • 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
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  • 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

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  • 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
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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

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