Prosigna Only Test Identified as Clearly Prognostic Both During First Five Years and Beyond Five Years Following Diagnosis
Seattle, May 12, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (Nasdaq:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the PAM50 gene signature, commercialized as the Prosigna® Breast Cancer Prognostic Gene Signature Assay, was included for the first time in the St. Gallen International Breast Cancer Guidelines. PAM50 was recognized among other multi-parameter molecular assays for its unique ability to estimate risk of recurrence both during the first five years and beyond five years following diagnosis. In addition, the Guidelines acknowledge the clinical utility of PAM50 for identifying women at low risk of recurrence who could be spared treatment with adjuvant chemotherapy.
The St. Gallen International Breast Cancer Conference convenes a forum of experts from major cooperative groups and centers world-wide who are actively engaged in basic and clinical research as well as clinical management of breast cancer patients. Forty-eight expert panelists responded to 200 questions regarding breast cancer research and treatment, and their answers are used to develop a consensus guideline. The newly updated St Gallen Consensus Summary is available at: http://annonc.oxfordjournals.org/content/early/2015/05/04/annonc.mdv221.full.pdf+html. A summary of the panelists' votes on each question is available at: http://www.oncoconferences.ch/mm//mm001/SG-BCC_2015_Vienna__Consensus_Voting_Results_Answers_in_-.pdf
Panelists agreed that PAM50 and several other multi-parameter assays identify patients for whom prognosis is so favorable that even if chemotherapy is effective, the benefits of treatment are so small that they do not outweigh the risks. The panel also recognized the clinical utility of PAM50's prognostic score, noting that chemotherapy could be omitted in hormone receptor positive early-stage breast cancer patients with low PAM50 ROR scores even if clinicopathological variables suggested a higher risk of recurrence. Among all prognostic tests evaluated, PAM50 secured the highest percentage of panelist votes for being prognostic over the first five years following diagnosis (93% of panelists), and was the only test for which a majority of panelists recognized prognostic value more than five years after diagnosis. Predicting the probability of recurrence between years five and 10 following diagnosis may help clinicians determine the value of continuing endocrine therapy beyond the initial five years.
"We are pleased that the St. Gallen International Breast Cancer Guidelines have recognized that women with low Prosigna risk scores may be able to forgo unnecessary treatment with chemotherapy," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "This is the second breast cancer guideline in 2015 to include Prosigna as an important diagnostic resource for women suffering from breast cancer. With these two recent acknowledgements, we are making clear progress toward our vision of ensuring that patients around the world have access to the best diagnostic technology."
In March of 2015, Prosigna was also included within the treatment guidelines of the German Association of Gynecological Oncology (AGO). Prosigna was recognized as a highly precise prognostic assay with level 1B evidence, a rating that is as strong as that given to any competing test. The AGO guidelines noted that that genomic tests should be used to select patients for whom clinical pathologic features alone do not allow clinician to make a clear therapeutic decision.
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.
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 over 700 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 has also been applied to diagnostic use. 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.
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: Leigh Salvo of Westwicke Partners