On March 21, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that Noridian Healthcare Solutions, LLC, a Medicare Administrative Contractor (MAC) for two Medicare jurisdictions covering 13 states, has issued favorable final local coverage determinations (LCDs) for the Prosigna Breast Cancer Assay, effective for services provided on or after May 3, 2016 (Press release, NanoString Technologies, MAR 21, 2016, View Source [SID:1234509770]).
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"The favorable LCDs published by Noridian represent an important step forward in ensuring patients have access to Prosigna," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "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. Our reimbursement team is working aggressively to further expand coverage to reach as many patients as possible."
The final LCDs, which are consistent with the draft guidance issued by Noridian on October 1, 2015, confirm the coverage policy for Medicare beneficiaries, and include reimbursement coverage for postmenopausal patients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 LCDs are posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website at: View Source;ContrId=364 and View Source;ContrId=345.
The final LCDs apply to the JE jurisdiction, comprising California, Nevada, Hawaii, Guam, American Samoa and Northern Mariana Islands, and the JF jurisdiction, comprising Washington, Oregon, Idaho, Montana, Wyoming, North Dakota, South Dakota, Utah, Arizona and Alaska.
About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System
The Prosigna 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. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that 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 Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.
The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.
In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.
In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.
For more information, please visit www.prosigna.com.