December 5, 2016

NanoString Technologies Highlights Presentation of Multiple Prosigna/PAM50 and Immuno-Oncology Studies at the 39th Annual CTRC-AACR San Antonio Breast Cancer Symposium

SEATTLE, Dec. 05, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced advances in precision oncology using the Prosigna® Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). In addition, numerous customers will be presenting data generated using NanoString's nCounter® Analysis System, including several involving immuno-oncology.

"The volume and impact of the clinical research being presented at the SABCS underscores our commitment to improving the lives of breast cancer patients," said Brad Gray, president and chief executive officer of NanoString Technologies. "These studies demonstrate that our Prosigna Assay can improve decision-making in early-stage breast cancer today, and that a modified companion diagnostic version of this assay has future potential in triple negative breast cancer. The studies also show that our nCounter Analysis System is continuing to grow in prominence as an important tool among breast cancer researchers."

NanoString and its collaborators will present three oral presentations and fourteen posters covering Prosigna/PAM50 and other nCounter-based research at SABCS, which is being held December 6-10, 2016.

Following are details for each presentation of data involving Prosigna and the PAM50 gene signature (all times are in Central Standard Time):

Wednesday, December 7, 2016

  • Abstract: P1-07-10
    Poster: Prediction of 10 year distant recurrence (DR) using the Prosigna® (PAM50) assay in histological subgroups of a Danish Breast Cancer Cooperative Group (DBCG) cohort of postmenopausal Danish women with hormone receptor-positive (HR+) early breast cancer (EBC) allocated to 5yr of endocrine therapy (ET) alone
    Authors: Laenkholm A-V, Jensen M-B, Buckingham W, Schaper C, Knoop A, Eriksen JO, Rasmussen BB, Ferree S, Haffner T, Kiboel T, Ejlertsen B.
    Location: Hall 1
    Time: 5:00 - 7:00 p.m. 

  • Abstract: P1-09-09
    Poster: Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer
    Authors: Prat A, Ortega V, Villagrasa P, Paré L, Galván P, Oliveira M, Nucíforo P, Lluch A, Morales S, Amillano K, Lopez R, Gonzalez R, Manso L, Martinez J, Llombart A, De la Peňa L, Di Cosimo S, Rubio IT, Harbeck N, Baselga J, Cortés J
    Location: Hall 1
    Time: 5:00 - 7:00 p.m.

Thursday, December 8, 2016

  • Abstract: P2-05-04
    Poster: Evaluation of intra-tumor heterogeneity, test reproducibility and their impact in breast cancer samples assessed by Prosigna: results from a Decision Impact prospective study and a matched case-control study
    Authors: Rouzier R, Bonneau C, Cayre A, Hequet D, Gentien D, Bonhomme A, Mouret-Reynier M-A, Dubot C, Cottu P, Roulot A, Morel P, Salomon A, Callens C, Guinebretiere J-M, Penault-Llorca F
    Location: Hall 1
    Time: 7:30 - 9:00 a.m. 

  • Abstract: P2-03-03
    Poster: Molecular differences between screen-detected and interval breast cancers are largely explained by PAM50 subtypes
    Authors: Czene K, Ivansson E, Klevebring D, Tobin NP, Lindström LS, Holm J, Prochazka G, Hilliges C, Palmgren J, Törnberg S, Humphreys K, Hartman J, Frisell J, Rantalainen M, Lindberg J, Hall P, Bergh J, Grönberg H, Li J
    Location: Hall 1
    Time: 7:30 - 9:00 a.m. 

  • Abstract: P2-05-16
    Poster: Establishment of molecular profiling for individual treatment decisions in early breast cancer - clinical impact of PAM50 and PAM50 risk of recurrence score after more than 16 years follow up.
    Authors: Naume B, Borgen E, Falk RS, Ohnstad HO, Lien TG, Aaserud M, Sveli MAT, Kyte JA, Kristensen V, Geitvik G, Schlichting E, Wist E, Sørlie T, Russnes H
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.  

  • Abstract: S3-03
    Oral Session: General Session 3
    Poster: PAM50 intrinsic subtype as a predictor of pathological complete response following neoadjuvant dual HER2 blockade without chemotherapy in HER2-positive breast cancer: First results of the PAMELA clinical trial
    Authors: Prat Aparicio A, Cortes Castan J, Pare L, Galvan P, Bermejo B, Martínez N, Vidal M, Pernas S, Lόpez R, Muñoz M, Nuciforo P, Fasani R, Morales S, Oliveira M, de La Peña L, Peláez A, Llombart A
    Location: Hall 3
    Time: 10:00 a.m.

Friday, December 9, 2016

  • Abstract: S6-05
    Oral Session: General Session 6: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC
    Authors: Sestak I, Buus R, Cuzick J, Dubsky P, Kronenwett R, Ferree S, Sgroi D, Schnabel C, Baehner R, Mallon E, Dowsett M.
    Location: Hall 3
    Time: 4:15 p.m.

Saturday, December 10, 2016

  • Abstract:  P6-07-01
    Poster: Development of a Prosigna® (PAM50)-based classifier for the selection of advanced triple negative breast cancer (TNBC) patients for treatment with enzalutamide
    Authors: Danaher P, Skewis L, Mashadi-Hossein A, Carey C, Ram N, Gowen-MacDonald J, Harris E, Cesano A, Ferree S, Uppal H, Buckingham W.
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.

Additional abstracts and posters demonstrate the diverse applications and robust performance of the nCounter® Analysis System in immuno-oncology and biomarker validation, including:

Wednesday, December 7, 2016

  • Abstract: P1-05-22
    Poster: The value of RNA-Seq for the detection of clinically actionable targets in breast cancer - A small cohort analysis  
    Authors: Meissner T, Amallraja A, Mark A, Andrews A, Connolly C, Young B, De P, Williams C, Leyland-Jones B        
    Location: Hall 1
    Time: 5:00 p.m.

Thursday, December 8, 2016

  • Abstract: P2-04-07
    Poster: Immune profiling of post neoadjuvant high metastatic risk (RCB-II/III) residual disease in patients with early triple negative breast cancers
    Authors: Irshad S, Cheang M, Gazinka P, Naidoo K, Buus R, Pinder S, Dowsett M, Tutt A        
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.  

  • Abstract: P2-04-19
    Poster: Elucidating the tumor immune microenvironment phenotype in early stage untreated BRCA mutated breast cancer patients  
    Authors: Force J, Abbott S, Broadwater G, Kimmick G, Westbrook K, Hwang S, Kauff N, Stashko I, Weinhold K, Nair S, Hyslop T, Blackwell K, Castellar E, Marcom PK
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.    
                          
  • Abstract: S4-01
    Oral Session: General Session: A novel BRD4 inhibitor enhances endocrine therapy efficacy and circumvents endocrine-resistance in estrogen receptor-positive breast cancer models  
    Authors: De Angelis C, Nardone A, Cataldo ML, Fu X, Trivedi M, Yi S, Breckenridge D, Chamnsess GC, Vitorino P, Osborne CK, Schiff R
    Location: Hall 3
    Time: 3:15 - 5:00 p.m.   

  • Abstract: PD5-06
    Poster: Prognostic value of molecular tumor infiltrating lymphocyte (mTIL) signatures in HER2-positive breast cancer patients in N9831 and FinHer/FinXX trials  
    Authors: Chumsri S, Serie DJ, Mashadi-Hossein A, Tenner KS, Lauttia SL, Moreno-Aspitia A, McLaughlin SA, Nassar A, Warren S, Danaher P, Colon-Otero G, Lindman H, Joensuu H, Perez EA, Thompson EA        
    Location: Stars at Night Ballroom 1&2 - 3rd Level
    Time: 5:00 - 7:00 p.m.                           

Friday, December 9, 2016

  • Abstract: P4-07-06
    Poster: MicroRNAs associated with acquired taxane resistance in a breast cancer cell line model  
    Authors: Taylor KJ, Chong T, D'Costa A, Yao C, Gourley C, Cameron DA, Bartlett JMS, Spears M 
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.  
                           
  • Abstract: P4-12-09
    Poster: The immune response in triple negative breast cancer
    Authors: Gillgrass AE, Pond GR, Levine MN, Whelan TJ, Hassell JA, Bane AL  
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.                           

Saturday, December 10, 2016

  • Abstract: P6-07-07
    Poster: ESR1 amplification and 5'-3' exon imbalance in metastatic breast cancer
    Authors: Oesterreich S, Basudan A, Preideigkeit N, Hartmaier RJ, Bahreini A, Gyanchandani R, Leone JP, Lucas PC, Hamilton RL, Brufsky AM, Lee AV  
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.  

  • Abstract: P6-09-47
    Poster: The development of personalized diagnostic tests and therapeutic strategies in breast cancer
    Authors: Kutasovic JR, Rozali E, Miranda M, Lakhani SR, Al-Ejeh F
    Location: Hall 1
    Time: 7:30 - 9:00 a.m.                           

You can learn more about the Prosigna Breast Cancer Gene Signature at booth #525.

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 510(k) cleared for use on the nCounter Dx Analysis System, and 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, Argentina, Thailand, South Africa, Turkey 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.

Other uses of Prosigna or the PAM50 panel in studies as described in this press release are for Investigational Use Only, or Research Use Only. 

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

About NanoString Technologies, Inc.
NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company's nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in more than 1,350 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology is also being used in diagnostics. The Prosigna® Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer. In addition, the company is collaborating with multiple biopharmaceutical companies in the development of companion diagnostic tests for various cancer therapies, helping to realize the promise of precision oncology.

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

The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.

Contact:



Doug Farrell

Vice President, Investor Relations & Corporate Communications

dfarrell@nanostring.com

Phone: 206-602-1768 

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Source: NanoString Technologies

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