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In-vitro diagnostic tests

18
Aug 2025

August 2025 update of the Catalog of Genetic and Genomic Tests in Spain

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.
13
Aug 2025

Positive HAS opinion for regular reimbursement of NGS panels in two indications in France

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.
07
Aug 2025

Reimbursement for biomarker tests in breast cancer expanded in Germany

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.
11
Jul 2025

Initiated and published mini-HTAs in Norway since early 2025

Since January 2025, three MedTech-related mini-HTAs were initiated in the areas of men’s health, in-vitro diagnostics, and diagnostic imaging as a part of a framework for the managed introduction of innovations "New Methods" in Norway. Furthermore, 11 mini-HTAs were published in this period, including cardiovascular, e-health, gastrointestinal, men’s health, and spine areas.
03
Jul 2025

Coverage positions published by the Dutch Healthcare Institute in Q1-Q2 2025

In the first and second quarters of 2025, the Dutch Healthcare Institute (ZIN) published three coverage positions concerning the ENT, gastrointestinal, and in-vitro diagnostic fields. Two of the three decisions (Internal nasal valve correction for airway blockage and molecular diagnostics of the NTRK gene fusion in cancer patients) received favorable recommendations for coverage under basic health insurance.