Medicare publishes draft coverage for Nanostring Prosigna test

On May 14, 2015, the Palmetto MolDX contractor published a draft local coverage decision favorable to the Nanostring Prosigna test.  Prosigna is a gene panel algorithmic test which is cleared by the FDA as a distributed test running on the Nanostring nCounter platform.

Draft LCD DL36125 is online here or in the cloud as a PDF here.   Nanostring's website is here.  Press release here.  Coverage at Genomeweb here (subscription).
The draft LCD states:

This policy provides limited coverage of the Prosigna breast cancer gene signature assay to patients that meet the following criteria consistent with the FDA indications for use:

• Postmenopausal female either:
• ER+, lymph-node negative, stage I or II breast cancer, or
• ER+, lymph-node positive (1-3 positive nodes), stage II breast cancer.

Prosigna recently had a favorable review in guidance of the St. Gallen group for breast cancer (here) and in other European guidance (here).

The same draft LCD has been released in the CGS KY/OH jurisdiction (here).