Premaitha Health plc and Esperite NV have announced the signing of an agreement under which Genoma SA (“Genoma”, Geneva, Switzerland), the fully owned subsidiary of Esperite will have the right to use Premaitha’s CE-IVD IONA® test for its non-invasive prenatal testing (NIPT) service called TRANQUILITY®. Access to Premaitha’s test will allow Genoma to apply the CE-IVD marking to its NIPT for trisomies 21, 18 and 13.
The IONA® test is the first CE-marked in vitro diagnostic (IVD) product for NIPT. It uses next-generation sequencing (NGS) 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 NIPT test is more sensitive and specific than the current combined test, providing accurate and reliable results to pregnant women. The benefits of NIPT are a higher detection rate and lower false positive rate than existing screening tests, giving pregnant women, their families and their doctors greater confidence in the result. This further reduces the need for unnecessary invasive follow-up tests and the associated anxiety and stress.
Dr Stephen Little, CEO of Premaitha said: “This agreement with Genoma to provide our CE-marked NIPT solution to its laboratories is a major milestone for us as Premaitha’s first sale in Europe. Genoma has the strength of infrastructure and the high technical expertise to be able to accelerate the broad dissemination of NIPT in Europe, ensuring its benefits are available to many pregnant women. The completion of this agreement so soon after receiving our CE mark is also a major achievement. We hope this will be the first of many agreements for the IONA® test and we look forward to a strong and fruitful partnership with Genoma.”
Dr Frederic Amar, CEO of Genoma said: “The CE-IVD certification will allow us to bring our NIPT test TRANQUILITY® to the next level. Premaitha offers us the access to a technology that has proven to be efficient, fast, and robust. We will carry out the TRANQUILITY® NIPT test in our state-of-the-art genetic analysis laboratories located in Geneva, in accordance with the highest quality standards. We are happy that our customers can benefit from these advantages, and we look forward to working closely with Premaitha.”