Premaitha Health PLC Approved for Good Manufacturing Process in Brazil (0773P)
August 29 2017 - 2:01AM
UK Regulatory
TIDMNIPT
RNS Number : 0773P
Premaitha Health PLC
29 August 2017
Premaitha Health plc
("Premaitha" or the "Company")
Premaitha approved for Good Manufacturing Practice by ANVISA
Brazil
Manchester, UK - 29 August 2017: Premaitha Health plc (AIM:
NIPT) announces that it has been approved for Brazilian Good
Manufacturing Practice ("B-GMP") for the Company's IONA(R) test by
Brazil's regulatory authority, the Agência Nacional de Vigilância
Sanitária ("ANVISA").
Premaitha is a leading international molecular diagnostics group
focused on non-invasive prenatal testing ("NIPT"). The B-GMP
approval enables Premaitha to proceed with the official application
to register the IONA(R) test with ANVISA - Brazil's National Health
Surveillance Agency. Premaitha is working closely with Thermo
Fisher's local team who will be the Brazilian registration holder
and the Company anticipates that registration will take
approximately six months. Once registered, the IONA(R) test will be
available to be sold in Brazil as an in-vitro diagnostic product
("IVD").
Premaitha's IONA(R) test estimates the risk of a fetus being
affected with Down's syndrome and other genetic conditions. The
test is performed on the 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, commented: "Brazil's IVD registration
process has a number of high hurdles to overcome and to have
obtained B-GMP approval is a very positive development for the
IONA(R) test. The approval also demonstrates the high quality
processes we have embedded at Premaitha, and our effective
collaboration with Thermo Fisher.
"We hope to complete full product registration by early 2018 and
to launch the IONA(R) test in Brazil shortly thereafter. Brazil is
a very important market in its own right with over three million
births per annum and increasing awareness of the benefits and
availability of non-invasive prenatal testing. It is also a
platform from which to expand into South and Central America, which
is another important region in the Company's geographic expansion
strategy to drive scale opportunities, and to de-risk our
intellectual property exposure."
For more information, please contact:
Premaitha Health plc Tel: +44 (0)
161 667 6865
Dr Stephen Little, Chief Executive
Office
Barry Hextall, Chief Financial
Officer
Joanne Cross, Head of Marketing
investors@premaitha.com
Cairn Financial Advisers LLP (Nomad) Tel: +44 (0)
20 7213 0880
Liam Murray / James Caithie
finnCap (Broker) Tel: +44 (0)
20 7220 0500
Adrian Hargrave / Scott Mathieson
(Corporate Finance)
Tony Quirke (Corporate Broking)
Vigo Communications Tel: +44 (0)
20 7830 9701
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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