Cigna has issued a positive medical coverage policy decision for the Prosigna breast cancer gene signature assay from NanoString Technologies Inc, Seattle.

The positive coverage decision is in line with updated American Society of Clinical Oncology guidelines released in February, in which Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.

Brad Gray, NanoString Technologies.

Brad Gray, NanoString Technologies.

“We estimate that more than 80% of patients indicated for Prosigna testing are now covered, and our team is dedicated to working with the remaining health insurance providers to ensure that their patients have access to this important test,” says Brad Gray, president and chief executive officer of NanoString Technologies.

The assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. The in vitro diagnostic tool utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The assay measures gene expression levels of RNA extracted from formalin-fixed, paraffin embedded breast tumor tissue previously diagnosed as invasive breast carcinoma. It runs on NanoString’s proprietary nCounter Dx analysis system, designed to offer a reproducible way to profile many genes simultaneously with high sensitivity and precision.

The updated healthcare policy for Cigna is available here.

Cigna and its roughly 13 million members join other payors now covering Prosigna, collectively representing more than 135 million covered lives throughout the United States.

For more information, visit NanoString Technologies.