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Agendia's MammaPrint Gets Blue Shield of California Coverage

NEW YORK (GenomeWeb) – Agendia said on Thursday that its MammaPrint 70-gene signature breast cancer recurrence risk test is now covered by Blue Shield of California.

According to the company, the payor has updated its medical policy to state that "the use of MammaPrint is considered medically necessary in women who are diagnosed with primary invasive breast cancer."

"It is estimated that almost 28,000 women in California will be diagnosed with breast cancer this year," Agendia CEO Mark Straley said in a statement. "The decision by Blue Shield of California to include MammaPrint in their coverage recognizes the benefits of this test in identifying those patients who could safely forgo chemotherapy and the highest level of clinical evidence that supports it."

The coverage decision follows the publication last year of data indicating that women with early-stage breast cancer who are at high clinical risk of recurrence might not need adjuvant chemotherapy if they are at low genomic risk as determined by MammaPrint. It also comes just months after the test received the highest evidence labels of the European Group on Tumor Markers and the German Association of Gynecological Oncology.

And in March, First Coast Service Options — the Medicare contractor for Florida, Puerto Rico, and the Virgin Islands — revised its local coverage determination for gene expression profiling panels for the management of breast cancer treatment to include MammaPrint.