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Myriad Genetics' EndoPredict Test Receives New Coverage From 17 Insurance Plans

NEW YORK (GenomeWeb) – Myriad Genetics announced late Friday afternoon that 17 new insurance plans have released positive coverage policies for its EndoPredict breast cancer test.

The plans include Blue Shield of California, Humana, and multiple regional plans. Further, Myriad said, Highmark Blue Cross Blue Shield, Independence Blue Cross, and Health Care Service Corporation have posted positive coverage policies which take effect in July 2017. These plans altogether represent more than 35 million covered lives raising the total of lives covered for EndoPredict to 109 million.

The test combines assessment of a 12-gene molecular score with clinicopathological features, like tumor size and nodal status, in order to identify clinically low-risk breast cancer patients who may safely forgo chemotherapy.

On May 4, Medicare contractor Palmetto GBA issued several draft local coverage determinations, including a positive coverage decision for EndoPredict. Palmetto's draft LCD for the assay includes limited coverage for postmenopausal women diagnosed with early-stage estrogen-receptor (ER) positive, HER2-negative breast cancer, who are either lymph node-negative, or who have up to three positive nodes, and for whom treatment with adjuvant endocrine therapy is being considered. In the draft LCD, Palmetto mentioned that EndoPredict shares the breast cancer prognostic space with several other molecular tests, including Nanostring's Prosigna and Genomic Health's Oncotype DX Breast.

If the draft LCD is approved, and combined with the current private coverage for the test, EndoPredict would be covered for approximately 75 percent of breast cancer patients in the US, Myriad added.

"The ramp in coverage for EndoPredict has been extremely rapid and we are very close to having nearly full coverage for this important test," Myriad President and CEO Mark Capone said in a statement. "We believe this unprecedented ramp in coverage is reflective of the strong data including the head-to-head study which showed that EndoPredict 'markedly outperformed' the first-generation test in breast cancer patients."