Premaitha Health plc and Centrum Badan DNA group in Poland have announced a collaboration agreement for Premaitha to supply its CE-marked in vitro diagnostic (IVD) the IONA® test for non-invasive prenatal screening (NIPT) to Centrum Badan.
The two companies will work closely together as they establish Centrum Badan as Premaitha’s preferred partner laboratory within Poland.
The IONA® test is the first CE-marked in vitro diagnostic (IVD) product for NIPT, enabling genetic laboratories such as Centrum Badan to offer NIPT in-house. It uses next-generation sequencing (NGS) technology to estimate the risk of a fetus having serious genetic disorders such as 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® has a higher detection rate and lower false positive rate than the current combined test available to pregnant women in Poland.
Last year there were 376,000 live births in Poland according to the Polish Statistical Office, and the uptake of NIPT tests is on the increase. The IONA® test will be available for pregnant women who wish to have a private non-invasive screening test and Centrum Badan will work with national hospitals wishing to offer high-risk pregnant women the test.
Jacek Wojciechowicz, CEO of Centrum Badan, commented: “In our opinion, the IONA® test is superior over other tests due to the complete workflow package from DNA extraction through to analysis software and reporting. Premaitha’s test also offers the highest accuracy and reliability with results available to clinicians in just three days. Having exclusive access to the only regulated CE-IVD NIPT in Europe for the pregnant women of Poland is a significant commercial advantage to our company. We anticipate launching the IONA® test in Poland over the next few weeks and look forward to working with the Premaitha team.”
Dr Stephen Little, CEO of Premaitha said: “We have selected Centrum Badan as our preferred collaborator in Poland due to the company’s technical next-generation sequencing expertise and its close network of obstetricians and clinicians. This collaboration is another fantastic endorsement of our IONA® test following so soon after our recent contract wins in Switzerland with Genoma and in the UK with St George’s NHS Foundation Trust. We are very pleased with the progress we are making across Europe to bring NIPT to pregnant women.”