Molecular diagnostics

On 30 September 2026, Italy published two decrees updating the national Essential Levels of Care (Livelli Essenziali di Assistenza, LEA). The changes combine an approximately €149.5 million expansion of nationally covered services, including new screening programmes, IVD tests and prosthetic aids, with resource-neutral revisions to existing coding, nomenclature and prescribing requirements. Together, the measures expand coverage for selected technologies while updating the conditions governing access to existing services.

On September 23, 2026, the National Cancer Strategy Roadmap was released in Finland. It describes the measures, responsibilities, schedules, and conditions for implementing the strategy in practice during the first five-year period (2026-2031). The objectives are to develop person-centered services, reduce the cancer burden through prevention and early detection, and ensure effective and equitable care. Overall, implementation of the National Cancer Strategy is estimated to require approximately €140 million in additional investment.

In September 2026, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system, introducing 114 new codes across medical biochemistry, microbiology, genetics, clinical pharmacology, and immunology. The regular update reflects changes in laboratory practice and ensures that the coding and reimbursement infrastructure continues to accommodate new and evolving diagnostic tests.

On July 16, 2026, NHS England updated the 2026/27 National Genomic Test Directory (NGTD), initially published in April 2026. The directory lists genomic tests commissioned by NHS England and provided through Genomic Laboratory Hubs. One new test was added to the directory for haematological oncology. Three new multi-target NGS panels, including one ctDNA (liquid biopsy), were added to the directory for non-CNS cancers for carcinoma of unknown primary origin.

On June 2, 2026, the Decision of the National Union of Health Insurance Funds (UNCAM) updating the Nomenclature of Medical Biology Procedures (NABM) was released. The NABM is France’s primary permanent reimbursement catalog for in-vitro diagnostic tests covered under statutory health insurance. The update introduces regular reimbursement for four new codes, including two next-generation sequencing (NGS) panels that were previously covered temporarily under the innovative payment scheme (RIHN framework).

On May 18, 2026, the Decision Forum for “New Methods” updated its coverage decision for molecular gene profile analysis using Oncotype DX. The test, which has been covered since 2024 for postmenopausal patients with lymph node-positive HR-positive, HER2-negative, early-stage invasive breast cancer, will now also be covered for patients with lymph node-negative breast cancer.

In May 2026, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) published an updated reimbursement agreement (Convention) for next-generation sequencing (NGS) in oncology and hemato-oncology. Multiple changes were introduced, including seven new reimbursement categories (Pseudocodes) covering additional clinical indications and new supplements for performing NGS or RNA sequencing (RNA-seq) on liquid biopsy samples in limited solid tumor indications. The updated Convention will enter into force on July 1, 2026.

On April 8, 2026, NHS England published the 2026/27 National Genomic Test Directory. The key update concerns hematological and neurological cancers, for which separate files were published with a significant restructure: new genomic test (GT) codes were introduced, gathered into new clinically relevant test packages (TP), and mapped to existing M-codes. Furthermore, multiple changes were made in the rare and inherited diseases directory, including the addition of several new codes.

In January 2026, the UK National Screening Committee (UK NSC) published details of EquipoISE, a new framework to help evaluate whether multiple additional rare conditions could be added to the UK Newborn Blood Spot (NBS) Screening Programme. EquipoISE is designed as a rolling multi-condition in-service evaluation that works within the existing NHS screening pathway to answer key questions about test performance, clinical outcomes, and feasibility in real-world NHS settings.

On December 31, 2025, the Ministry of Health, Family, Autonomy, and People with Disabilities published a Decree, amending the conditions of temporary coverage for innovative IVD tests via the RIHN framework (included in the List of Innovative Procedures Outside the Nomenclature, LAHN). Changes include extending the maximum duration of transitional coverage from five to nine years and lowering the annual tariff reductions from 20% to 10%. The LAHN 2026 was also released, reflecting the changes introduced by a Decree.

On October 21, 2025, the French National Authority for Health (HAS) issued positive opinions on the inclusion of targeted next-generation sequencing-based panels for patients with multiple myeloma and lung cancer in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed as a part of the RIHN reform and ‘cleaning up’ the List of temporarily covered tests.

On October 20, 2025, Genomic Medicine Sweden (GMS) announced the launch of five strategic development projects aimed at extending access to advanced diagnostics nationwide. The projects will focus on updating national GMS gene panel (big NGS panel for solid tumors), liquid biopsies, cell-free tumor DNA (ctDNA) for diagnosis and follow-up of metastatic breast cancer, gene panels for hepatopancreatobiliary (HPB) cancer, and improving diagnosis of sarcoma.