TGA approves IONA® Nx for sale in Australia
Manchester, UK – 13 August 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces that its IONA® Nx NIPT workflow (‘IONA® Nx’), a non-invasive prenatal test (‘NIPT’), has been approved by Australia’s Therapeutics Goods Association (‘TGA’) as a medical device Class 3, allowing Southern Cross Diagnostics, Yourgene’s Australian distributor, to commence sales.
The TGA is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989.
Australia is the first major market outside of the UK / EU to have granted approval to IONA® Nx, following on from the CE-IVD approval it received on the 15 June, stating that the IONA® Nx was being readied for commercial launch in other geographies. The IONA® Nx is an in vitro nucleic acid screening test that measures the likelihood that a pregnant woman is carrying a fetus with Trisomy 13, 18 or 21. It is a laboratory based test that has been developed to run on the Illumina's NextSeq 550Dx instrument, a next generation sequencing ("NGS") platform.
It is estimated that the birth rate in Australia is 300,000 per annum1 and the increase of women having their first child over the age of 30 (risen from 23% in 1991 to 48% in 2016)1 is expected to result in increased demand for NIPT, demonstrating the importance of this target market for the Group.
Lyn Rees, CEO of Yourgene Health plc, stated: “This is a key milestone for the Company, which opens up one of the major healthcare markets in the world to our leading product and complements our existing product sales in that country. Southern Cross is already carrying out a superb job operating as our sole distributor for our reproductive health portfolio of PCR tests, in addition to our DPYD oncology product, which received TGA approval back in February this year. We look forward to mirroring that success with our NIPT product.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.