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Premaitha Health Launches the IONA® Test

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Premaitha Health plc has announced the 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 authorized 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 analyzing 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 standardized 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.