Laboratory Corp. of America Holdings ( LH ) announced the commercial launch of Prosigna Breast Cancer Prognostic Gene Signature Assay. This U.S. Food and Drug Administration (FDA)-approved product has been developed by NanoString Technologies, Inc. ( NSTG ). Following the announcement, the share price of LH inched up 0.30%.
The Prosigna assay is an in-vitro diagnostic tool and is based on the PAM50 gene signature. It utilizes gene expression data and provides a risk category and numerical score for assessment of the risk of distant recurrence at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), Hormone Receptor-Positive (HR+) breast cancer. The Prosigna score is indicated in patients who have undergone surgery along with locoregional treatment.
The Prosigna assay was researched upon extensively in two independent clinical studies. The results of the studies indicated successful performance of the product. The Prosigna score offered substantial prognostic information and greater prognostic clarity as compared with other predictive breast cancer assays such as the Oncotype Dx Breast Cancer Assay.
Laboratory Corp. values its association with this new-age prognostic test. The company expects the Prosigna test to make monitoring and treatment of breast cancer recurrence easier for physicians, when used in combination with other clinical and pathological factors.
In Dec 2013, NanoString had announced the adoption of the Prosigna Assay by ARUP Laboratories, LH and Quest Diagnostics ( DGX ), three major U.S. laboratories and cancer centers. Laboratory Corp. is the first center that has introduced the product at a commercial level.
Clinical Diagnostics is an important operating segment within LH. It has contributed nearly 94.1% to the company's total revenue, for nine months in 2013. We believe the market availability of the Prosigna assay will further strengthen Laboratory Corp.'s suite of diagnostic tests and accelerate core organic growth for the company.
Currently, LH has a Zacks Rank #5 (Strong Sell). A better-ranked stock in the medical/dental supplies industry is Align Technology Inc. ( ALGN ) with a Zacks Rank #1 (Strong Buy).