Dáil Éireann Debate, Tuesday - 7 October 2025
710. Deputy Emer Currie asked the Minister for Health if her plans to build national capacity for clinical genetic testing includes the establishment of a public sector-run national genomics laboratory; if so, the anticipated timeline for this development; the level of funding required; and if she will make a statement on the matter. [53930/25]
View answer712. Deputy Emer Currie asked the Minister for Health the Irish public hospital laboratories that are accredited to ISO 15189:2022 standard to deliver for clinical genetic tests; if she will specify the clinical genetic tests for which they hold this accreditation; and if she will outline the average turnaround times for these laboratories in delivering results back to the requesting clinician and patient. [53932/25]
View answer713. Deputy Emer Currie asked the Minister for Health if she will address the current fragmented approach to ordering clinical genetic tests in Ireland; her plans to build national capacity to avoid the unnecessary practice of patient blood samples being sent abroad; the timeline for this capacity to be built; if it will be public sector centred; and if she will make a statement on the matter. [53933/25]
View answer714. Deputy Emer Currie asked the Minister for Health if she will consider issuing national clinical genetic testing guidance to clinicians, similar to the guidance provided for medicines and medical technologies, advising which ISO 15189:2022 accredited commercial and public clinical genetic laboratories in Ireland are recommended, competent and appropriately accredited to conduct tests in-country and abroad, in the interest of realising efficiencies in the area of health expenditure and ensuring tests are conducted in accredited facilities; and if she will make a statement on the matter. [53934/25]
View answer716. Deputy Emer Currie asked the Minister for Health if she agrees with the HSE’s practice of using Children’s Health Ireland (CHI) as a postal conduit for a significant proportion of the approximately 20,0000 patient blood samples requiring genetic testing, particularly given that these samples are ultimately dispatched abroad to laboratory service providers in countries such as UK, Germany and Finland; if she will clarify how this arrangement can be justified in terms of efficiency, cost-effectiveness, patient data governance, given the availability of competent accredited laboratory capacity in Ireland; and if she will make a statement on the matter. [53936/25]
View answer717. Deputy Emer Currie asked the Minister for Health her plans to drive cost efficiencies in view of the fact that 20,000 clinical tests are sent to laboratories in Germany, Finland, Spain, the UK, and the USA; if the HSE utilises existing capacity of Ireland-based accredited commercial clinical genetic testing laboratories for patients blood samples, including neurology, ophthalmology, and nephrology genetic tests; and if she will make a statement on the matter. [53937/25]
View answerI propose to take Questions Nos. 710, 712 to 714, inclusive, 716 and 717 together.
Currently, individual hospitals manage their own arrangements for processing genomic samples, with some sites sending them overseas while others have the capacity to process certain samples in-house. The Public and Private genetic laboratories in Ireland that are accredited to the EN ISO 15189:2022 standard can be found on the Irish National Accreditation Board (INAB) Website Directory www.inab.ie/inab-directory/laboratory-accreditation/medical-testing-laboratories/. The turnaround time for a test relies on several factors, including sample travel time and internal lab variables such as the chosen analytical method, instrument time, and priority order, meaning it is not possible to provide a single turnaround time across the full spectrum of laboratory testing.
The National Strategy for Accelerating Genetic and Genomic Medicine in Ireland published in 2022, sets out a vision to transform existing services and enhance laboratory infrastructure to accelerate the advancement of genetics and genomics to the benefit of Irish patients. The HSE’s National Genetics and Genomics Office (NGGO) was established in 2023 to implement the Strategy, focusing on several key strategic areas including:
• Coordinating a national approach to genetics and genomics.
• Ensuring patient and public involvement and partnerships.
• Building the genetics and genomics workforce for the future.
• Enhancing genetic and genomic clinical services.
• Strengthening infrastructures to drive advances in genetics and genomics.
At the end of 2024, the NGGO published the first version of the National Genomic Test Directory for Rare and Inherited Disease. Developed collaboratively with clinical specialists and laboratory colleagues, the Test Directory identifies the appropriate genomic test, the expected requesting clinical specialties, and the clinical indications and criteria for patient testing. Version 1 includes tests for clinical indications from the specialties of Cardiology, Lipids, Metabolic, Mitochondrial, and Ophthalmology. Throughout 2025 and 2026, the NGGO will continue to work on developing further versions of the Test Directory for additional clinical specialties.
The NGGO is also advancing the development of a centralised National Genomic Processing Service (NGPS), which will enable the operationalisation of the Test Directory. The NGPS will act as a hub for the receipt and referral of specimens from hospitals across Ireland for genomic testing and will coordinate the reporting of results back to the requesting hospitals and consultants. The NGGO will also be progressing a public procurement process for genomic tests associated with the Test Directory, requiring tendering laboratories to have a quality assurance system in place as a prerequisite. It should be noted that in implementing the National Strategy, any necessary procurement of services is governed by the Office of Government Procurement's guidelines to ensure transparency, efficiency, and value for money.
As the implementation of the Strategy progresses, my Department and the NGGO are actively streamlining processes to improve efficiency and are investigating opportunities to bolster our national capacity through the establishment of a National Genomic Medicine Centre. The development of a single centralised laboratory for all genomic testing under the governance of the HSE, will future-proof Ireland’s genomic testing capabilities and will support ongoing research, with the data generated representing a key resource for researchers, while aligning with Ireland's participation in EU working groups for the 1+ Million Genome (1+MG) Initiative.
My Department and the NGGO will continue to work closely on the implementation of the National Strategy.
