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Germany Grants National Reimbursement for Three Additional Breast Cancer Biomarker Tests

NEW YORK – Germany's government-funded health insurance will start covering three additional breast cancer biomarker tests that can help doctors and patients decide whether adjuvant chemotherapy after surgery is indicated.

According to an announcement on Thursday by the Federal Joint Committee (G-BA), which makes coverage decisions for Germany's public health insurance, Myriad Genetics' EndoPredict, Agendia's MammaPrint (distributed in Germany by PathoNext), and Veracyte's Prosigna (developed by NanoString Technologies) will now be covered.

The decision comes a year after Exact Sciences' Oncotype DX Breast Recurrence Score, developed by Genomic Health prior to its acquisition by Exact, obtained coverage in Germany.

About 70,000 women in Germany get diagnosed with early-stage breast cancer every year, and for about 20,000 of them, treating physicians cannot recommend adjuvant chemotherapy based on clinical and pathology criteria alone. For those women, a biomarker test could have clinical utility.

Following review by the Federal Ministry of Health, the three additional tests are expected to be reimbursed, at a rate that has yet to be negotiated. Germany's government-funded health insurance covers about 73 million individuals.