Biotech group to launch new prenatal test product

Manchester biotech group Yourgene Health has received the go-ahead to launch its Illumina-based IONA test, the company’s flagship non-invasive prenatal test product for Down’s syndrome and other genetic disorders.

The test will now be readied for commercial launch across the European Union, including the UK, as well as other countries that accept the CE-IVD mark.

As Europe emerges from the restrictions implemented due to the coronavirus pandemic, the company expects to roll-out the IONA Nx to its laboratory customers across the UK and Europe in the coming months, as well as establishing its own laboratory-based test service using IONA Nx at the company’s facilities in Manchester.

Yourgene will work with its customers to allow technical installations to take place that ensure social distancing within the lab and remote work will be undertaken to ensure customers have access to the IONA Nx test as soon as possible, despite current travel restrictions.

Yourgene chief executive, Lyn Rees, said: “We’re delighted to announce CE marking for our Illumina-based IONA test, the IONA Nx.

“I am very proud of the Yourgene team who have worked incredibly hard to make the market-leading accuracy of the IONA NIPT product available to labs across Europe that use Illumina’s next generation sequencing (NGS) technology.

“Given that Illumina’s NGS technology accounts for around 75% of the global NGS market, we look forward to working in partnership with them to expand our reach into significant parts of the market that were previously unavailable to us.”