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Medicare Contractor Issues Favorable Final LCD for NanoString Prosigna Test

NEW YORK(GenomeWeb) – NanoString on Thursday announced that Medicare contractor Palmetto GBA has issued a favorable final local coverage determination under its MolDx program for the firm's Prosigna breast cancer assay.

The final LCD confirms the coverage policy for Medicare beneficiaries and includes reimbursement coverage for postmenopausal patients with ER+, lymph node-negative, stage I or II breast cancer; and ER+, lymph node-positive (1-3 positive nodes), stage II breast cancer. The guidance becomes effective on or after Oct. 1, 2015 and applies to North Carolina, South Carolina, Virginia, and West Virginia. Other Medicare jurisidictions may subsequently choose to adopt the same coverage policy, NanoString said.

The Prosigna breast cancer assay calculates a risk category and numerical score to help physicians assess the risk of recurrent disease. A study published in July suggested that Prosigna scores could also predict a patient's response to chemotherapy.

"The policy decision is expected to increase patient access across Prosigna's entire intended use population, including patients with both node-negative and node-positive breast cancer," NanoString CEO Brad Gray said in a statement.

The LCD follows a positive draft guidance Palmetto issued in May. In recent months, updates to clinical care guidelines have acknowledged the clinical validity of the test. In March, the German Association of Gynecological Oncology published treatment guidelines acknowledging the usefulness of the assay, and in July the National Comprehensive Cancer Network updated its clinical practice guidelines to acknowledge that the PAM50 gene signature, which Prosigna is based on, has been clinically validated to predict prognosis.