NanoString Technologies says a second clinical validation trial looking at whether its new breast cancer diagnostic test could accurately gauge the risk of recurrence for a particular kind of breast cancer generated robust results with a high degree of accuracy. That good news, the company adds, will form the basis of its FDA regulatory submission for the assay (though it remains coy as to when that will be).
Positive clinical results will also help propel the test's European launch in early 2013, following a CE mark earlier this fall. The company has had a hearty fall, also attracting $15.3 million in Series E funding to help propel the assay's commercial launch, as well as commercial preparations.
This second clinical trial is known as ABCSG8 (Austrian Breast & Colorectal Cancer Study Group 8) and involved evaluating more than 1,400 patient samples using the PAM50 gene expression signature. Simply put, the test was proven to be highly accurate in gauging the risk of cancer recurrence over 10 years in women, post menopause, who have hormone-receptor-positive early-stage breast cancer and are treated with endocrine therapy alone. In other words, the data met primary and secondary objectives, echoing similar results from last year's TransATAC study.
Diagnostics are attracting healthy investor attention, something that NanoString's executives are well aware of. The company began its existence as a scientific toolmaker but jumped into a new diagnostics clinical development program two years ago. And the company hopes to leverage its connection to the PAM50 gene signature, for which the company says it has an exclusive global license. Over time, it hopes to develop both in vitro diagnostics and research products for breast cancer using the PAM50 gene signature.
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