James O'Connor (Cork East, Fianna Fail)
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2056. To ask the Minister for Health if any reviews or audits of the expenditure on laboratory genetic testing services, both in Ireland and abroad, have been undertaken to ensure value for money and to assess the effectiveness of outsourcing; whether it is the intention to support local accredited capacity; and if she will make a statement on the matter. [19018/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

James O'Connor (Cork East, Fianna Fail)
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2057. To ask the Minister for Health to confirm whether all laboratories, both domestic and overseas, used by clinicians for genetic testing are fully accredited to the appropriate national or European standards; what measures are in place to ensure consistent quality control and reliable results from these laboratories; and if she will make a statement on the matter. [19019/25]

James O'Connor (Cork East, Fianna Fail)
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2058. To ask the Minister for Health to provide details on the current number of ISO15189-accredited genetic laboratories that exist within the public health system; if the HSE has capacity to develop and implement a comprehensive national genetic testing strategy; her plans to enhance staffing and infrastructure in order to meet the growing demands for genetic and diagnostic testing services; and if she will make a statement on the matter. [19020/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2057 and 2058 together.

The genetic laboratories in Ireland that are accredited to the EN ISO 15189 standard and which are available for public testing are available on the Irish National Accreditation Board Website (INAB) Directory Testing Laboratories - see: www.inab.ie/inab-services/laboratory-testing/directory-of-testing-laboratories/

The HSE’s National Genetics and Genomics Office (NGGO) was established in 2023 to implement the National Strategy for Accelerating Genetic and Genomic Medicine in Ireland (2022), and its activities include coordinating a national approach to genetics and genomics, ensuring patient and public involvement (PPI) and partnerships, building the genetics and genomics workforce for the future, enhancing genetic and genomic clinical services, and 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 (the Test Directory) as an advisory document. The Test Directory which was developed by the NGGO through a series of collaborative workshops with clinical specialists and their laboratory colleagues, identifies the appropriate test, the list of clinical specialist areas which would be expected to request the test, and clinical indications and criteria setting out which patients should be considered for testing under that indication. Version 1 of the Test Directory 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 with clinicians and laboratory scientists to develop further versions of the Test Directory that will provide advice on genomic testing for additional clinical specialties.

The NGGO, with support from my Department, is also advancing the development of a centralised National Genomic Processing Service (NGPS), which will enable the operationalisation of the Test Directory by ensuring that the right test is requested for the right patient at the right time in the right laboratory. The NGPS will support the use of the Test Directory and will be a hub for receipt of specimens from hospitals across Ireland to refer for genomic testing by laboratories abroad. The service will also coordinate the reporting of results back to the requesting hospitals and consultants.

The NGGO and my Department will continue to work closely in implementing the National Strategy, including options for enhancing genomic testing capacity.