Premaitha Health PLC Premaitha's IONA test approved for sale in Brazil (8534D)
February 05 2018 - 1:00AM
UK Regulatory
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
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