NanoString's gene expression breast cancer Dx gains CE mark

Seattle's NanoString Technologies revealed this week that it has gained a CE mark for a gene expression molecular diagnostic test for breast cancer.

The turnaround for NanoString's PAM50-based gene expression test was relatively short--approval came less than two years after the company began its clinical development program, the company said. Almost a year ago, investors including GE, BioMed Ventures and former Genzyme CEO Henri Termeer contributed to a $20 million Series D round for the company that helped fuel final work behind the diagnostic test. A clinical validation study involving more than 1,000 samples helped support the CE mark filing, and NanoString's test can be used on its nCounter platform.

As Xconomy reports, the approval is a milestone for NanoString, which started out as a maker of scientific tools and began a push a few years ago to branch out into diagnostics. CEO Brad Gray, himself a former Genzyme executive, joined the company to help it move into the diagnostic space, the article reminds us.

The new gene expression test will provide a subtype classification based on particular breast tumor's fundamental biology, the company explains, plus a score that predicts how likely it would be for cancer to recur over a decade in women with a type of early stage breast cancer who received hormone replacement therapy.

One it hits the market by early 2013, the NanoString test will compete with rivals including Genomic Health, Xconomy notes. In the coming weeks, the company will bring on local sales reps and pursue reimbursement agreements with each country's health regulators in the ramp up to the commercial market.

- read the release
- here's Xconomy's coverage