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Noridian Issues Favorable LCD for NanoString's Prosigna Breast Cancer Assay

NEW YORK (GenomeWeb) – Noridian Healthcare Solutions has issued a favorable final local coverage determination for NanoString Technologies' Prosigna breast cancer assay.

The LCD is effective for services provided on or after May 3. Noridian is a Medicare Administrative Contractor for two jurisdictions covering 13 Western US states, including Arizona, California, Oregon, Utah, and Washington as well as US territories in the Pacific such as Guam.

"When the Noridian LCD becomes effective, Medicare will cover Prosigna for breast cancer patients in 39 states, in line with the assumptions underlying our expectations for Prosigna this year," NanoString CEO Brad Gray said in a statement. "Our reimbursement team is working aggressively to further expand coverage to reach as many patients as possible."

The Prosigna breast cancer assay is based on the PAM 50 gene expression signature and calculates a risk category and numerical score to help physicians assess the risk of recurrent disease. It runs on the NanoString nCounter platform.

The announcement follows Noridian's draft guidance issued Oct. 1, 2015, and confirms the coverage policy for Medicare beneficiaries. It includes reimbursement coverage for postmenopausal patients with either ER+, lymph node-negative, stage I or II breast cancer or ER+, lymph node-positive stage II breast cancer with one to three positive nodes.

Noridian joins Medicare contractor Palmetto GBA, which also issued a favorable final LCD for Prosigna in August 2015.