EU Clearance for NanoString’s Breast Cancer Diagnostic Test

NanoString has received CE Mark designation from the European Union, which allows the company to begin marketing its nCounter instrument as a diagnostic tool for patients with breast cancer. NanoString will now take the next steps in sharpening its European marketing strategy in major countries, hiring local sales reps, and negotiating for reimbursement from health authorities in each country. The plan is to start selling its first diagnostic systems in Europe by early 2013, says CEO Brad Gray.

“This has been the culmination of two-plus years of work to establish our diagnostics business,” Gray says. “It’s the end of a major process and beginning of a whole new era of Nanostring’s existence.”

NanoString, a spinoff from the Institute for Systems Biology in Seattle, introduced the first commercial version of its tool in the summer of 2008, for research only. The technology provides scientists with a digital readout on the extent to which genes are dialed on or off in a sample—what’s known as gene expression analysis. The tool has gained popularity the past couple years with academic customers, especially those at The Broad Institute of MIT and Harvard, because of its ability to help spot patterns in complex diseases like cancer where 50 or 100 genes might be perturbed instead of just one.

Brad Gray, a former Genzyme executive, was brought in as CEO to help the company branch out from a scientific toolmaker into a more diversified company that makes instruments for scientific and diagnostic purposes. The company moved in that direction in December 2010 when it got a license to use the PAM50 gene signature on its system, which enables doctors to look at how an array of 50 genes are expressed in a breast cancer sample. NanoString presented data a year later which said this 50-gene array was able to help researchers determine when a woman with breast cancer had a “low,” an “intermediate,” or a “high” risk of a cancer recurrence.

Those findings, presented last December at the San Antonio Breast Cancer Symposium, were the basis of NanoString’s application for regulatory approval in the EU, and they will be part of a planned application to the U.S. Food and Drug Administration, Gray says.