Signal Genetics Announces Publication of BreastPRS™ Validation Study with Weill Cornell Medical College, New York

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Multi-gene Assay for Breast Cancer Prognosis and Personalized Diagnostic Profiling Shown to Resolve Oncotype DX Intermediate Risk Patients

Scatter plot of 246 FFPE breast cancer specimens analyzed by both Oncotype DX and BreastPRS. Both prognosis scores are positively correlated with increased risk of cancer recurrence in ER+ patients.

BreastPRS test has the potential to provide physicians improved breast cancer prognostication and more critical personalized information. It is now much more than a viable alternative.

Signal Genetics today announced that the results of a retrospective Weill Cornell validation study of BreastPRS, a novel series of prognostic and molecular profiling algorithms for breast cancer, has been published in the medical journal ‘Breast Cancer Research and Treatment’. Signal Genetics, LLC, is a privately held molecular diagnostic company based in New York, NY and Little Rock, AR.

Ryan Van Laar, Ph.D., Head of Bioinformatics & New Product Development at Signal Genetics said “We are excited about the results of this independent study, which determines that our BreastPRS test has the potential to provide physicians improved breast cancer prognostication and more critical personalized information. It is now much more than a viable alternative.”

The publication is titled “BreastPRS is a gene expression assay that stratifies intermediate-risk Oncotype DX patients into high- or low-risk for disease recurrence.”[1]. The study was performed by re-analyzing breast cancer tissue from 246 Weill Cornell patients whose tissue had previously been analyzed with Oncotype DX® by Genomic Health® (CA) . Gene expression analysis and BreastPRS calculations were performed in Signal Genetics’ CLIA-certified laboratory in Little Rock, AR.

The correlation between recurrence score and risk groups generated from the Oncotype DX and BreastPRS methods was highly statistically significant (P < 0.0001). Notably BreastPRS was found to reclassify Oncotype DX intermediate-risk patients into two groups with significant differences in recurrence free survival, potentially offering physicians an alternative method of breast cancer prognostication, which includes molecular grade and molecular subtyping algorithms to provide a comprehensive personalized analysis of each patient’s disease.

BreastPRS has also been used by researchers at the Windber Research Institute (Windber, PA) to examine the impact of recent ASCO/CAP guideline changes for determining ER status. The study was published in the Annals of Surgical Oncology (2013 Jan; 20(1): 87-93)

Signal Genetics is seeking licensing partners to further develop BreastPRS as a stand-alone prognostic test for patients with breast cancer. For more information contact Signal Genetics by emailing info(at)signalgenetics(dot)com.

[1] Timothy M. D’Alfonso, et al. BreastPRS is a gene expression assay that stratifies intermediate-risk Oncotype DX patients into high- or low-risk for disease recurrence. Breast Cancer Research and Treatment. June 2013, Volume 139, Issue 3, pp 705-715

Genomic Health and Oncotype DX are registered trademarks of Genomic Health, Inc.

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Sam Riccitelli
Signal Genetics LLC
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