SEATTLE--()--NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced it has obtained the CE Mark for its PAM50-based gene expression test for breast cancer, clearing the company to sell its test in the European Union and other countries recognizing the CE Mark.
“We are delighted to complete our first regulatory filing for our PAM50-based gene expression diagnostic test for breast cancer less than two years after beginning our rigorous clinical development program”
NanoString’s test provides a subtype classification based on the fundamental biology of an individual’s breast tumor (referred to as intrinsic subtyping), as well as a prognostic score that predicts the probability of cancer recurrence over 10 years in post-menopausal women with hormone receptor-positive, early stage breast cancer (ESBC) who have been treated with hormonal therapy. Together with studies from the literature, this information has been shown to convey valuable information about a patient’s prognosis that can inform critical decisions about the patient’s course of therapy.
“We are delighted to complete our first regulatory filing for our PAM50-based gene expression diagnostic test for breast cancer less than two years after beginning our rigorous clinical development program,” said Bruce Seeley, Senior Vice President & General Manager, Diagnostics at NanoString Technologies. “Women and their clinicians in countries that accept the CE Mark will soon have a new option for informing important treatment decisions, and for bringing more certainty to those decisions. This filing is right on the heels of the landmark study from The Cancer Genome Atlas that demonstrated the power of the PAM50 for subtyping breast cancer into four distinct diseases, and importantly the clinical use of intrinsic subtyping is already included in the St. Gallen International Breast Cancer Treatment Guidelines.”
NanoString intends to begin marketing its breast cancer test in major markets that accept the CE Mark in early 2013. The company has a worldwide license for the PAM50 gene signature to develop in vitro diagnostic and research products for breast cancer on its nCounter® Analysis System. The clinical development program for NanoString’s PAM50-based breast cancer test is designed to support both regulatory requirements for market-specific approval and its incorporation into worldwide breast cancer treatment guidelines.
“PAM50 on the nCounter platform represents the next generation in genomic testing for breast cancer, providing a powerful new tool for reliable and accurate genomic testing that can be done in local laboratories in countries that recognize the CE Mark,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “This regulatory filing is an important milestone in NanoString’s vision to support the global democratization of genomic testing, and make high-impact gene-profiling tests widely available as in vitro diagnostic products. We extend heart-felt congratulations and gratitude to our collaborators who contributed to this achievement.”
The CE Mark is based on positive results from NanoString’s first clinical validation study, as well as a recently completed multi-site analytical validation study. The results of the clinical validation study, which included more than 1,000 samples from the TransATAC study of postmenopausal women with hormone receptor-positive early-stage breast cancer (ESBC), were presented by the study’s independent investigators at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The results of the multi-site analytical validation study are expected to be presented at a major clinical meeting during 2013.
The test that is the subject of the CE Mark is available in the United States as Investigational Use Only. The test runs on the nCounter system, which is presently offered in the United States as Research Use Only, and is not intended for diagnostic use in the United States.
More information is available at www.NanoString.com.
About NanoString Technologies, Inc.
NanoString Technologies is a privately held provider of life science tools for translational research and developer of molecular diagnostics. The company’s nCounter Analysis System is the first and only technology platform to deliver highly multiplexed, direct profiling of individual molecules in a single reaction without amplification. The nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. NanoString is also developing the technology for use in molecular diagnostics.
The NanoString Technologies design logo, NanoString, NanoString Technologies and nCounter are registered trademarks of NanoString Technologies, Inc. All other trademarks are property of their respective owners.