Premaitha welcomes NIPT recommendation in France

Premaitha Health plc

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 tests ("NIPT") available to women across France.

HAS published its recommendation this week that NIPT should be offered as a standard procedure to high and intermediate risk women (those with a trisomy risk between 1:51 and 1:1000 of having a pregnancy affected by Down's syndrome or certain other genetic conditions) following first trimester combined test screening. These recommendations will now be reviewed and evaluated by the French Ministry of Health, before formalising the introduction of tests into the French healthcare system.

The recommendation by HAS anticipates that an introduction of NIPT for intermediate and high risk women would result in a 75% reduction in the number of women subjected to unnecessary invasive diagnostic procedures which are costly, resource intensive and carry a risk of miscarriage. 

Premaitha has already successfully established a strong presence in France. The IONA® test is now widely accepted as a leading test by both clinicians and laboratories in the country and, as such, Premaitha is well placed to offer the benefits of the IONA® test to women in France.

Dr Stephen Little, CEO, commented: "We are delighted that yet another country is moving towards making NIPT freely available to high risk women. It is notable that the HAS recommendation is extended to included intermediate risk women too which should greatly increase the target test population. The availability of NIPT to high and intermediate risk women should also create additional awareness amongst low risk women seeking to pay for NIPT for peace of mind. With the IONA® test already installed in multiple laboratories in France, we are extremely well positioned to grow our business there."

Further information can be found on the HAS website:

https://www.has-sante.fr/portail/jcms/c_2768510/fr/place-des-tests-adn-libre-circulant-dans-le-sang-maternel-dans-le-depistage-de-la-trisomie-21-foetale 

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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® 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® 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® 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® 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.