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Veracyte Announces Further European Reimbursement Expansion for Prosigna Breast Cancer Test
Only Test of Its Kind to Be Recommended for Use in All Swedish Healthcare Regions Without Restrictions SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
About this update from Veracyte, Inc.
[{"type":"text","content":"\nOnly Test of Its Kind to Be Recommended for Use in All Swedish Healthcare Regions Without Restrictions\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVeracyte, Inc. (Nasdaq: VCYT) today announced that the Swedish Medical Technologies Product (MTP) Council has recommended the Prosigna Breast Cancer Assay for immediate reimbursement and clinical use in all Swedish healthcare regions without legal restrictions beginning November 22, 2021. The milestone follows recent G-BA reimbursement approval in Germany and underscores the test’s continued reimbursement momentum in the European Union.\n\nThe recommendation from the Swedish MTP Council’s first-ever process of its kind specifies that physicians can use the Prosigna assay to help make decisions about adjuvant chemotherapy in individual women over the age of 50 with certain types of breast cancer when there is uncertainty about the benefit of this treatment. It is based on a prior positive assessment from the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds Läkemedelförmånsverketthe, TLV), which conducted a health technology assessment (HTA) and concluded that the Prosigna test is a cost-effective genomic diagnostic technology for breast cancer.\n\nThe Prosigna assay is the only breast cancer genomic test that is both CE-IVD marked and recommended by the MTP Council without legal caveats regarding either General Data Protection Regulation (GDPR) compliance or adherence to processing of personal data requirements in Sweden and the European Union. The Prosigna test is performed locally by laboratories in Sweden and other countries on the nCounter Analysis System instrument.\n\n“The positive TLV and MTP recommendations represent an important milestone for women with breast cancer throughout Sweden, because it makes it possible for them and their physicians to access the Prosigna test without restrictions to inform individual treatment decisions,” said Morten Frost, Veracyte’s general manager, Pulmonology and Breast Cancer. “The Swedish HTA is internationally recognized as a robust assessment with strict evidence and cost-effective requirements. We believe this recommendation reflects the robust evidence supporting the Prosigna assay, and we are actively working to make the test available to physicians and breast cancer patients who could benefit from it in other Europ...