On December 7, 2015 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that eleven posters for the Prosigna Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 38th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) (Press release, NanoString Technologies, DEC 7, 2015, View Source [SID:1234508451]). The presentations include:

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Multiple decision impact studies demonstrating Prosigna’s influence on adjuvant therapy selection by physicians
A study by the Danish Breast Cancer Group validating previous observations that the Prosigna risk of recurrence score can predict the probability of loco-regional recurrence

Studies evaluating the ability of Prosigna/PAM50 to predict response to various therapies in the neoadjuvant and metastatic setting
A study describing the differences in intrinsic subtype distribution between patients of African descent and Caucasian descent
A description of the ongoing OPTIMA clinical trial, describing the prospective evaluation of Prosigna as a test to identify node-positive breast cancer patients who may be spared adjuvant chemotherapy

Following are details for the Prosigna/PAM50 posters to be presented (all times shown are Central Standard Time):

Thursday, December 10

Session #: Poster Session 2, P2-08-10
Abstract Title: Validation of prediction of local recurrence (LR) by Prosigna (PAM50) in a Danish breast cancer cooperative group (DBCG) cohort of hormone receptor positive (HR+), postmenopausal early breast cancer (EBC) patients allocated to 5yr of endocrine therapy (ET)
Location: Halls A-B
Time: 7:30AM – 9:00AM

Session #: Poster Session 2, P2-08-16
Abstract Title: Prognostic and predictive abilities of intrinsic subtype in hormone receptor-positive metastatic breast cancer from the EGF30008 phase III clinical trial
Location: Halls A-B
Time: 7:30AM – 9:00AM

Session #: Poster Session 3, P3-07-14
Abstract Title: Prosigna intrinsic subtyping predicts response to neoadjuvant combination therapy in study that includes herceptin within HER2+ (IHC) patients
Location: Halls A-B
Time: 5:00PM – 7:00PM

Session #: Poster Session 3, P3-07-15
Abstract Title: Prosigna subtype correlation is a strong predictor of response to neoadjuvant chemotherapy (NAC) in early breast cancer (EBC) study
Location: Halls A-B
Time: 5:00PM – 7:00PM

Session #: Poster Session 3, P3-07-42
Abstract Title: Predicting outcome and benefit to first-line bevacizumab in advanced/metastatic hormone receptor (HR)+/HER2-negative breast cancer (BC) treated with endocrine therapy: A correlative science study from the LEA phase III clinical trial (GEICAM/2006-11_GBG 051)
Location: Halls A-B
Time: 5:00PM – 7:00PM

Session #: Poster Session 3, P3-07-66
Abstract Title: Efficacy and gene expression results from eribulin SOLTI1007 neoadjuvant study
Location: Halls A-B
Time: 5:00PM – 7:00PM

Session #: Poster Session OT2, OT2-03-02
Abstract Title: DI study: Decision impact of the NanoString Technologies Prosigna in early breast cancers
Location: Halls A-B
Time: 5:00PM – 7:00PM

Friday, December 11

Session #: Poster Session 5, P5-07-03
Abstract Title: Prosigna results impact on adjuvant decision making in early breast cancer (EBC): Final analysis of the prospective WSG study
Location: Halls A-B
Time: 5:00PM – 7:00PM

Session #: Poster Session OT3, OT3-02-12
Abstract Title: OPTIMA (optimal personalised treatment of early breast cancer using multi-parameter analysis), a prospective trial to validate the predictive utility and cost-effectiveness of gene expression test-directed chemotherapy decisions
Location: Halls A-B
Time: 5:00PM – 7:00PM

Saturday, December 12

Session #: Poster Session 6, P6-04-05
Abstract Title: Genotype-phenotype classification of triple negative breast cancers (TNBC) in women of African descent using the PAM50 NanoString platform and genomic data
Location: Hall C
Time: 7:30AM – 9:00AM

Session #: Poster Session 6, P6-05-02
Abstract Title: Intrinsic subtype and gene expression changes between primary and metastatic breast cancer
Location: Hall C
Time: 7:30AM – 9:00AM
About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System

The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.

In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.

For more information, please visit www.prosigna.com.