NEW YORK (GenomeWeb News) – NanoString Technologies said after the close of the market Monday that the US Food and Drug Administration has granted 510(k) clearance of the firm's Prosigna Breast Cancer Prognostic Gene Signature Assay.
The assay is based on the PAM50 gene signature and analyzes the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence of disease. Prosigna is NanoString's first FDA-cleared product and runs on the firm's nCounter Dx Analysis System.
The assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years. It is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, said NanoString.
"We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the US market," Bruce Seeley, senior VP & GM of diagnostics for NanoString, said in a statement. "By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions."
NanoString said that Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity CLIA-certified labs late in the fourth quarter this year, while Prosigna testing services are expected to be available through qualified US clinical labs at the beginning of 2014.
Prosigna has already been CE-marked and is available in Europe and other countries that recognize the CE Mark, NanoString noted.
NanoString President and CEO Brad Gray noted on the firm's second quarter conference call last month that the company had been recruiting its US commercial leadership team and preparing materials for submissions to payors and guideline committees in advance of the Prosigna clearance and launch.
In Tuesday morning trade on the Nasdaq, shares of NanoString were up 23 percent at $9.40.