Laboratory Corporation of America Holdings (LabCorp) has announced the launch of the Prosigna Breast cancer prognostic gene signature assay, an FDA approved breast cancer prognostic gene signature assay developed by NanoString Technologies.
Prosigna provides a risk category and a numerical score to assess the probability of breast cancer recurrence in certain female breast cancer patients.
For postmenopausal female breast cancer patients who have undergone surgery in conjunction with locoregional treatment, Prosigna’s assessment of recurrence can be a useful tool in conjunction with other clinical and pathological factors to help guide treatment and monitoring strategies.
The Prosignatest is based on a 50 gene signature assay analyzed on a proprietary NanoString system. The clinical performance of the assay was validated in two large independent studies that included over 2,400 patients.
Both studies demonstrated that the Prosigna score provided substantial prognostic information beyond that normally derived from existing standard clinical variables, such as nodal status, tumor size and grade, patient age and prior treatment, to predict a patient’s recurrence-free survival at 10 years.
In addition, the studies showed that Prosigna was able to categorize more patients as high risk and fewer as intermediate risk, providing more prognostic clarity, compared to results from other predictive breast cancer assays such as the Oncotype Dx breast cancer assay.
LabCorp chief medical officer Dr Mark Brecher noted the company is pleased to be among the first laboratories to offer the FDA approved Prosigna assay.
"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," Dr Brecher added.