NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced it has secured an exclusive worldwide license from Bioclassifier, LLC to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping.
The company also stated its goal to become the platform of choice for diagnostic testing based on multiplexed gene expression signatures that can be offered in hospitals and pathology laboratories worldwide, following appropriate regulatory approvals.
More than a decade of research, clinical studies, and peer reviewed publications support the value of intrinsic subtyping based on gene expression analyses to assess prognosis and treatment options for breast cancer patients. The Bioclassifier team, a partnership of four breast cancer experts from four leading research institutions, has advanced this field by creating and validating the “PAM50” gene signature. The NanoString Breast Cancer Intrinsic Subtyping Assay will be based on the PAM50 gene signature and will be designed to measure the expression levels of these 50 genes in formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue samples.
Research suggests that the subtype classification and prognostic score generated by the PAM50 gene signature provides information about the fundamental biology of breast cancer that cannot be gained through other currently available diagnostic tests. It may provide clinically useful information for a broader range of breast cancer subtypes, including classification of tumors from patients with estrogen receptor negative, or node positive forms. NanoString intends to collaborate with leading breast cancer researchers to clinically validate the gene signature on its nCounter® Analysis System, and plans to seek regulatory approvals from the FDA and other relevant agencies outside the U.S. for the NanoString Breast Cancer Intrinsic Subtyping Assay.
Charles Perou, Ph.D., Professor of Genetics, and Pathology at The University of North Carolina at Chapel Hill and a member of UNC Lineberger Comprehensive Cancer Center, a co-founder of Bioclassifier, stated: “We had a goal to translate our decade of work on the intrinsic subtypes into a distributed test that could help breast cancer patients across the globe. We believe NanoString is the partner with the ideal technology to bring gene expression profiling into the clinical setting. The technology is robust and reproducible, works with the sample types routinely used in clinical practice, and is the simplest digital counting technology available.”
“Intrinsic subtyping has entered the lexicon of breast cancer researchers and oncologists alike,” said Bioclassifier co-founder Matthew Ellis, M.D., Ph.D. “Upon validation and regulatory approval, we believe this gene expression panel will become part of the standard of care for breast cancer diagnosis and treatment, and will be useful in the evaluation of all newly diagnosed breast cancer patients.” Dr. Ellis also directs the Breast Cancer Program at the Washington University School of Medicine at St. Louis.
Additional co-founders of Bioclassifier include Philip Bernard, M.D., Associate Professor in the Department of Pathology at the University of Utah/Huntsman Cancer Institute, and Torsten Nielsen, M.D., Ph.D., Pathologist, BC Cancer Agency.
“Leading oncology researchers are finding that the nCounter Analysis System is the ideal platform on which to validate their discoveries and translate them into clinically useful diagnostic assays,” said Brad Gray, President and CEO of NanoString Technologies. “We believe the NanoString Breast Cancer Intrinsic Subtyping Assay will be the first in a series of proprietary high-impact molecular diagnostic assays that we will commercialize as in vitro diagnostic products and that will be available in hospital and pathology laboratories worldwide.”
The company's executive management team will be attending this week's San Antonio Breast Cancer Symposium to discuss its plans for the NanoString Breast Cancer Intrinsic Subtyping Assay with experts in the field and identify other potential partners for its future molecular diagnostics platform.