Yourgene launches new non-invasive prenatal test

(Sharecast News) - Molecular diagnostics company Yourgene announced the launch of 'IONA Nx NIPT' workflow, a non-invasive prenatal test (NIPT), on Thursday.
The AIM-traded firm said the IONA Nx seeks to offer clinical labs a high performing, flexible, scalable and innovative NIPT service in-house, and was developed to run on the 'Illumina Nextseq 550 Dx' platform, for "next-generation" sequencing.

As it announced on 15 June, the IONA Nx received a CE-mark across the European Union, including the UK, as well as other countries that accept the CE-IVD mark.

Yourgene said it would initially transition existing customers in the UK and France, where it has an existing direct presence, to the IONA Nx.

The company also expected to see uptake of the product in other European territories, where it would use its recently-strengthened commercial team in Europe.

In addition, Yourgene said it would be targeting additional markets within the Illumina IP territory following regulatory approvals.

As it announced on 13 August, Australia's Therapeutics Goods Association (TGA) approved the IONA Nx as a class 3 medical device, allowing the firm's Australian distributor Southern Cross Diagnostics to start sales.

Further territories covered by the Illumina licence agreement would also be made available as regulatory submissions are approved.

Illumina's NGS technology accounts for around 75% of the global NGS market, with Yourgene saying the NIPT market in Europe alone was set to grow to $500m by 2025, putting the company in a "strong position" going forward.

The Yourgene NIPT service laboratory in Manchester was in the process of changing over to the IONA Nx, the board confirmed.

"We have already expanded our European sales team with key appointments in UK, France, Germany to support the commercial roll-out of the IONA Nx and we will look to give updates on key milestones such as regulatory approval and new customer wins," said chief executive officer Lyn Rees.

"Our IONA test has a strong reputation for reliability and accuracy and was the first CE-marked NIPT product for the European market.

"The new IONA Nx combines this gold standard for reliability and accuracy with a market leading sequencer and we believe this will be a strong driver of growth in the future."

Rees said the company expected to see accelerated double-digit growth in its NIPT business in the current year.

"We are confident that this will be delivered through a mix of organic growth across our existing NIPT customer base, the transition of existing customers to IONA Nx in current territories, as well through securing new customers and commencing sales in new territories."

At 1153 BST, shares in Yourgene Health were up 4% at 17.68p.