July 14, 2026 Newswires

Agendia Announces Definitive Mandatory Swiss Health Insurance Reimbursement for MammaPrint

Business Wire

Effective 1 July 2026, Switzerland’s FOPH completes its review of multigene expression testing, formally deciding to continue reimbursement indefinitely

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--
Agendia®, Inc., a leader in precision oncology for breast cancer, today announced the official ruling by the Swiss Federal Office of Public Health (FOPH) to grant definitive, mandatory health insurance (Obligatorische Krankenpflegeversicherung, or OKP) coverage for multigene expression tests, including MammaPrint® for eligible patients with early-stage breast cancer.

The tests are intended to help guide chemotherapy decision-making and have been covered by insurance since 1 January 2015, subject to evaluation. Effective 1 July 2026, this regulatory update successfully concludes a provisional evaluation framework establishing the diagnostics as a mandatory insurance obligation in the Swiss healthcare system.

Acting on a formal recommendation from the Federal Commission for General Benefits and Policy Issues (ELGK), the FOPH has amended Annex 1 of the Healthcare Benefits Ordinance (KLV) based on a comprehensive Health Technology Assessment (HTA).

The HTA report focused on the clinical efficacy, cost effectiveness, cost implications for statutory health insurance providers, and the ethical, legal, social, and organizational aspects of the four multigene expression tests currently used in Switzerland. The report confirmed MammaPrint’s ability to predict risk of recurrence, and together with relevant evaluations from other countries, informed the FOPH’s final assessment of the healthcare benefits criteria.

Eligibility for mandatory OKP reimbursement requires the patient’s breast cancer tumor fulfill the following conditions:

Receptor status: Must be estrogen receptor-positive and HER2-negative
Nodal involvement: Up to three loco-regional lymph nodes are affected
Diagnostic justification: Conventional findings alone do not allow for a clear decision regarding chemotherapy

“This definitive ruling brings clarity for the treatment of breast cancer patients across Switzerland," said Mark Straley, CEO of Agendia. "By anchoring these precision tests into Annex 1 KLV, the Swiss healthcare system ensures that clinicians can tailor care pathways based on the biology of the patient’s tumor, striking a vital balance between preventing overtreatment and protecting patients from disease recurrence."

About Agendia

Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company’s genomic assays, MammaPrint + BluePrint, CE IVDR number 39957, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.

About MammaPrint

MammaPrint is a gene expression profiling test that assesses a woman’s risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories — UltraLow Risk, Low Risk, High Risk 1, and High Risk 2 — to help guide personalized treatment planning, including chemotherapy benefit and de-escalation decisions.

About BluePrint

BluePrint is an 80-gene molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.