LabCorp (NYSE:LH) has launched a genes-based breast cancer test developed by NanoString Technologies. It’s the latest addition to genetics-based tests being offered by the lab testing giant.
The Prosigna test provides a risk category and numerical score that assesses the probability that breast cancer could recur in certain women who have had breast cancer. Seattle-based NanoString received Food and Drug Administration marketing clearance for the last September. The company later said that Prosigna would become available nationwide in the first quarter through diagnostic laboratories including Burlington-based LabCorp and Quest Diagnostics (NYSE:DGX).
NanoString said that the University of North Carolina Lineberger Comprehensive Cancer Center will be among the first wave of health care facilities that will offer the test in early 2014.
Prosigna is based on a 50-gene signature test that is analyzed on NanoString’s proprietary system. In clinical studies of the test, the Prosigna score offered more prognostic information than is typically found in standard clinical measures. The studies also showed that Prosigna was was able to categorize more patients as high risk and fewer as intermediate risk, yielding more prognostic clarity compared to results from other predictive breast cancer assays.
“LabCorp is pleased to be among the first laboratories to offer the FDA approved Prosigna assay,” stated Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “Prosigna provides physicians and their patients a new and important diagnostic tool, in conjunction with other clinical and pathological factors, to help monitor and treat breast cancer recurrence.”
