Eligibility for German Government Reimbursement to Begin for Qualifying Patients
Seattle, March 18, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that its Prosigna® Breast Cancer Assay is now acknowledged within the treatment guidelines of the German Association of Gynecological Oncology (AGO). In addition, under a recent decision by the German Joint Federal Committee (G-BA), qualifying German breast cancer patients with statutory government insurance will be eligible for coverage for gene expression testing, such as Prosigna, to inform therapy decisions.
"The inclusion of Prosigna in the German AGO breast cancer treatment guidelines marks an important milestone for NanoString," said President and Chief Executive Officer, Brad Gray. "In combination with upcoming insurance coverage of genomic testing by the government, the stage is set for substantially increased patient access to Prosigna in Germany."
In the AGO guidelines, Prosigna is indicated for newly diagnosed patients with node-negative or node-positive, hormone-receptor positive (HR+), HER2-negative (HER2-) early stage breast cancer, for whom clinical-pathological factors alone do not allow physicians to make a clear therapeutic decision. Prosigna is recognized as being prognostic with Level of Evidence 1B, a rating that is as strong as that given to any competing test. The guideline acknowledges the clinical utility of prognostic tests, citing the perspective from the Early Breast Cancer Trialists' Collaborative Group that "low absolute risk implies low absolute benefit."
The AGO is an independent body of the German Society of Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG). The AGO aims to promote science and research as well as the education and training of health professionals in the topics and areas of responsibility of gynecological oncology, including breast tumors. The AGO maintains multiple breast cancer treatment guidelines which are updated on an annual basis. The March 2015 version of the AGO breast cancer guidelines can be accessed on the AGO website at http://www.ago-online.de/en/guidelines-mamma/march-2015/.
In a separate decision made by the G-BA, qualified German breast cancer patients with statutory government insurance being treated in eligible hospitals will receive insurance coverage for gene expression testing, such as Prosigna, to inform therapy decisions. This policy will cover patients of at least 35 years of age, who have low-grade, HR+, HER2-, node-negative early stage breast cancer. The decision marks substantial progress for statutory insured patients because gene expression testing has previously only been covered for patients with private insurance. The decision will become effective upon review by the Federal Ministry of Health and publication in the Federal Bulletin, which are expected to occur in the second quarter of 2015. The decision can be found on the website of the Federal Joint Committee (G-BA) at https://www.g-ba.de/downloads/39-261-2164/2015-01-22_ASV-RL_gyn-Tumoren.pdf.
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 600 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, 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 now 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.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the anticipated availability of insurance coverage for Prosigna in Germany and the potential for increased usage as a result. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or other unforeseen problems with respect to manufacturing, product development or clinical studies; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.
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For NanoString Technologies