ADVFN Logo

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for discussion Register to chat with like-minded investors on our interactive forums.

NIPT Premaitha

9.10
0.00 (0.00%)
Last Updated: 00:00:00
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Premaitha LSE:NIPT London Ordinary Share GB00BN31ZD89 ORD 0.1P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 9.10 9.00 9.20 0.00 00:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Premaitha Health PLC Premaitha's IONA test approved for sale in Brazil (8534D)

05/02/2018 7:00am

UK Regulatory


Premaitha (LSE:NIPT)
Historical Stock Chart


From Mar 2019 to Mar 2024

Click Here for more Premaitha Charts.

TIDMNIPT

RNS Number : 8534D

Premaitha Health PLC

05 February 2018

Premaitha Health plc

("Premaitha" or the "Company")

Premaitha's IONA(R) test approved for sale in Brazil

Manchester, UK - 5 February 2018: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on prenatal testing, announces that the IONA(R) test has been approved by Brazil's regulatory authority, Agência Nacional de Vigilância Sanitária ("ANVISA"), for sale as an in vitro diagnostic ("IVD") test.

In September 2017, Premaitha announced that the Company's IONA(R) test had been approved by ANVISA for Brazilian Good Manufacturing Practice ("B-GMP"). B-GMP approval was required to enable Premaitha to proceed with this official application to register the IONA(R) test with ANVISA, which was completed ahead of expectations, in under three months.

The Company is now seeking commercial partners in Brazil to bring the benefits of non-invasive prenatal testing to pregnant women and their clinicians in the country.

Premaitha's IONA(R) test estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analysed using next generation DNA sequencing technology. The test is highly accurate and significantly reduces the number of women who are unnecessarily subjected to risky, invasive follow up procedures to diagnose Down's syndrome and other genetic conditions.

Dr Stephen Little, CEO of Premaitha, commented: "Commercialising the IONA(R) test in this significant South American market is another key step in Premaitha's diversification and de-risking strategy. Whilst the territory will not be immediately revenue generating, with over three million births per annum, we anticipate Brazil will become a major market for Premaitha and that it will in due course provide a springboard to other South and Central America regions.

"Furthermore, the rapid regulatory approval process is another endorsement of the quality management system Premaitha has built from the outset that is of a calibre suitable for multiple regulatory regimes of the highest standards globally."

-Ends-

 
For more information, please contact: 
                                            Tel: +44 (0)161 
  Premaitha Health PLC                       667 1053 
  Dr Stephen Little, Chief Executive 
  Officer 
  Barry Hextall, Chief Financial Officer 
  Joanne Cross, Head of Marketing 
  investors@premaitha.com 
Cairn Financial Advisers LLP (NOMAD)        Tel: +44 (0)20 
 Liam Murray / James Caithie                 7213 0880 
                                            Tel: +44 (0)20 
  finnCap (Broker)                           7220 0500 
  Adrian Hargrave / Scott Mathieson 
  (Corporate Finance) 
  Andrew Burdis / Abigail Wayne (Corporate 
  Broking) 
                                            Tel: +44 (0)20 
  Vigo Communications                        7830 9700 
  Ben Simons / Fiona Henson / Antonia 
  Pollock 
  premaitha@vigocomms.com 
 

About Premaitha

Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group's primary focus is on non-invasive prenatal tests (NIPT) for pregnant women - an emerging, multi-billion dollar global market.

Premaitha's IONA(R) test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA(R) test is performed on a maternal blood sample - which contains traces of fetal DNA - and estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions.

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

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha's IONA(R) test. Yourgene brings significant benefits to the Group through expanded market access in Asia - the world's fastest growing NIPT market - as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. 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.

This information is provided by RNS

The company news service from the London Stock Exchange

END

MSCEANALEFKPEFF

(END) Dow Jones Newswires

February 05, 2018 02:00 ET (07:00 GMT)

1 Year Premaitha Chart

1 Year Premaitha Chart

1 Month Premaitha Chart

1 Month Premaitha Chart

Your Recent History

Delayed Upgrade Clock