NanoString Technologies has secured an exclusive worldwide license from Bioclassifier, to develop in-vitro diagnostic (IVD) and research products for breast cancer intrinsic sub-typing.
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 US for the NanoString Breast Cancer Intrinsic Subtyping Assay.
NanoString Technologies president and CEO Brad Gray said 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.
"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," Gray said.