Company Profile.

Premaitha Health (Formerly ViaLogy PLC) is a molecular diagnostics company employing next generation DNA analysis technology to develop, manufacture and sell molecular diagnostic products intended to have a major beneficial impact on human health. Premaitha is responsible for the development, manufacture and commercialisation of their diagnostic products and works with partners to provide the instrument platforms needed by its laboratory customers. Premaitha Health was established in 2013 and is located on Manchester Science Park, Manchester, UK.

Premaitha’s first product is the IONA® test which is the first CE marked non-invasive in vitro diagnostic product for prenatal screening. The IONA® test is a complete diagnostic system that is simple and standardised, enabling Premaitha’s clinical laboratory customers to perform the test in their laboratory, using existing clinical workflow. A fundamental element of the IONA® test is exceptional technical support and customer service. The IONA® test is non-invasive, simple and accurate, and is designed to encourage the broad uptake of the technology allowing all pregnant women accurate and safe information about their pregnancy.

Premaitha is built upon a wealth of diagnostic expertise with an experienced management team, scientific and technical excellence and class leading quality management and development systems. Currently focused in the area of non-invasive prenatal tests (NIPT), Premaitha aims to extend its portfolio to cover oncology, personalised medicine and other areas of human health.


Premaitha's Admission and trading of its Ordinary Shares on AIM commenced at 08.00hrs today (TIDM: NIPT).

The Company has raised £7.2 million by way of a Placing and Open Offer at a price of 11p per share. The proceeds of the Placing and Open Offer will be used to commercialise the IONA(R)test and provide capital for the Enlarged Group's sales and marketing initiatives.

The Board consists of:-
David Evans - Non-Executive Chairman
Dr Stephen Little - Chief Executive Officer
Peter Collins - Chief Commercial Officer
Mark Collingbourne - Finance Director
Dr Charles Roberts - Non-Executive Director
Adam Reynolds - Non-Executive Director
Nick Mustoe - Non-Executive Director


Having not succeeded in their former role Vialogy is now an investment company and has changed their name to Premeitha after the Biotechnology company agreed terms to join Vialogy.

I expect there will be a fair bit of profit taking today and early next week maybe but after that, well who knows?!

This should get things moving!


Premaitha Health Launches the IONA® test, the First Ever
CE-marked NIPT Product for Pregnant Women

Manchester, UK - 5 February 2015 - Premaitha Health plc ("Premaitha" or the "Company", AIM: NIPT), an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal testing (NIPT) today announces receipt of CE mark approval and launch of the IONA® test, the first CE-marked in vitro diagnostic (IVD) Product for NIPT.

The CE Mark means that the IONA® test has met the stringent quality standards set down by the In Vitro Diagnostic Medical Device Directive (98/79/EC). Premaitha is the only company authorised by the European Regulatory agencies to sell a product to allow a laboratory to offer an NIPT service.

The IONA® test uses next-generation sequencing technology to estimate the risk of a fetus having Down's syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) and Patau's syndrome (Trisomy 13) by analysing cell-free fetal DNA from a sample of maternal blood. The IONA® test is more sensitive and specific than the current combined test, providing accurate and reliable screening results to pregnant women.

Dr Brenda Kelly, Consultant Obstetrician and Fetal Medicine Specialist at Oxford University Hospitals NHS Trust, said: "The launch of a regulated NIPT test is fantastic news for pregnant women and the clinical team caring for them. At present, a significant number of pregnant women who have a positive screening result with currently available combined and quadruple tests go through unnecessary and stressful follow-up invasive tests such as chorionic villus sampling and amniocentesis, each of which carries a risk of miscarriage. A more accurate and reliable NIPT like IONA® will mean fewer invasive tests and therefore, overall, fewer miscarriages."

Kelly added, "Hospitals across Europe and in the UK now have the option to provide a local test with a rapid turnaround and time to result which will allow pregnant women and their families to receive the information they need to make informed decisions in a much faster timeframe, reducing anxiety as much as possible."

Currently, pregnant women in Europe can only access NIPT via the private testing market provided by service laboratories. This involves sending a blood sample to a lab in the USA or China at considerable cost and with a cumulative waiting time for results of up to two weeks, compared to the IONA® test of only three days.

The IONA® test provides a complete system including DNA extraction through to data analysis with a standardised workflow that can quickly be implemented into clinical laboratories. Having their own solution will result in the acceleration of the broad dissemination of NIPT in Europe, ensuring its benefits are available to many more pregnant women.

Dr Stephen Little, CEO of Premaitha said: "The launch of the IONA® test is a huge milestone for Premaitha. We are the first company to offer a CE-marked NIPT product in an area where the current standard of prenatal testing is simply inadequate and there is a huge unmet need. By moving research technologies into a clinical environment, we are enabling laboratories in Europe to offer this important screening test.

"We have delivered on our promise made on joining AIM in 2014 to launch the IONA® test in early 2015 and we are in a very strong position to take advantage of what is potentially the single biggest opportunity in in vitro diagnostics with a multi-billion dollar potential. NIPT is being welcomed by pregnant women and their doctors, and we expect the uptake to be rapid. I believe that eventually all prenatal screening for trisomies will be based on this approach."

Premaitha is making the IONA® test available to laboratories and hospitals in Europe. The screening test will be rolled out in territories in Asia and the Middle East thereafter. A world-class pan-European commercial team led by Chief Business Officer Peter Collins, previously VP Diagnostics at GSK, is driving the launch. Premaitha's R&D, manufacturing and commercial operation is based at Manchester Science Park, UK.

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