NanoString commences second clinical study of PAM50-based breast cancer assay

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced the initiation of the second clinical validation study of its PAM50-based breast cancer assay. The new study will evaluate samples from more than 1,000 patients enrolled in the Austrian Breast & Colorectal Cancer Study Group 8 (ABCSG8) trial to test the ability of NanoString's assay to estimate the prognosis of postmenopausal women with hormone receptor-positive early-stage breast cancer.    

The ABCSG8 study, initiated in 1996, demonstrated that compared to treatment with tamoxifen alone, sequential adjuvant treatment with tamoxifen followed by anastrozole in postmenopausal women with hormone receptor-positive early-stage breast cancer decreased recurrence rates by 20%. Michael Gnant, MD, Professor at the Medical University of Vienna, is President of ABCSG and lead investigator of the new study. "Mounting evidence suggests an exciting role for the PAM50 gene signature in breast cancer clinical decision making," said Dr. Gnant. "Our current study is designed to build on the results recently presented by other investigators by confirming the ability of NanoString's assay to identify early-stage breast cancer patients with a low enough risk of distant recurrence that they may be spared unnecessary chemotherapy."

For this study, more than 1,000 samples from the ABCSG8 study will be analyzed using the NanoString PAM50-based assay on an nCounter^® Analysis System installed in the Center for Translational and Applied Genomics at the British Columbia Cancer Agency. Torsten Nielsen, M.D., Ph.D. a pathologist at the BCCA and the Genetic Pathology Evaluation Centre at Vancouver General Hospital is the lead pathologist on the study and co-inventor of the PAM50 gene signature. "The ABCSG8 study, in combination with analytical validation studies underway, is expected to rigorously test whether the nCounter technology can bring the power of genomic-based prognostic testing and reliable determination of intrinsic subtype to hospital and pathology laboratories worldwide," said Dr. Nielsen.

The clinical development program for NanoString's PAM50-based breast cancer assay is designed to support both its regulatory clearance and its incorporation into worldwide breast cancer treatment guidelines. Positive results from NanoString's first clinical validation study were presented last December by the study's independent investigators at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The study, which included more than 1,000 samples from the TransATAC study of postmenopausal women with hormone receptor-positive early-stage breast cancer (ESBC), met all primary and secondary objectives.

"The ABCSG8 study is part of our continued commitment to fully characterize the ability of the PAM50 gene signature and intrinsic subtypes to inform major treatment decisions in breast cancer by conducting clinical studies of the highest caliber," said Brad Gray, President and CEO of NanoString Technologies. "We are grateful for the opportunity to collaborate with Drs. Gnant and Nielsen, as well as other leaders in the breast cancer field, and look forward to the results of this study."