Molecular diagnostics

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.

On August 5, 2025, the Ministry of Labor, Health, Solidarity, and Families published the 2025 version of the List of Innovative Procedures Outside the Nomenclature (LAHN), which specifies tests funded under the innovative payment scheme for in-vitro diagnostics (RIHN). Tariffs for tests included in the LAHN were expected to decrease by 20% annually from January 1, 2025, except for those with a positive evaluation by the French National Authority for Health (HAS) in defined clinical indications. However, unlike previous edition, the 2025 LAHN does not specify tariffs. It introduces 14 new codes, which duplicate existing generic codes but are restricted to the clinical indications positively assessed by HAS. These new codes will be exempt from the annual tariff reduction.

In August 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System in Spain was updated. Two sections with a total of 140 new genetic tests were introduced: one for bone diseases, including craniofacial anomalies, and another for kidney diseases and urogenital disorders. Furthermore, six new tests were added in pediatric oncohematology. Other changes concerned adult oncohaematology, hereditary metabolic, and mitochondrial diseases.

On July 29, 2025, the French National Authority for Health (HAS) issued positive opinions on including targeted next-generation sequencing-based panels in certain clinical indications for patients with aminoacidopathy and acute leukaemia in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed by HAS as a part of the RIHN reform and ‘cleaning up’ the List of temporary covered tests.

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.