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NanoString Licenses Bioclassifier Technology

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – NanoString Technologies said late on Monday it has licensed worldwide rights to Bioclassifier technology to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping.

Bioclassifier, a partnership of four breast cancer experts from four research institutions, has created and validated the PAM50 gene signature, comprising 50 genes. In a statement, NanoString said that research suggests the subtype classification and prognostic score generated by the PAM50 signature "provides information about the fundamental biology of breast cancer that cannot be gained through other currently available diagnostic tests."

Additionally, the gene signature "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 will develop its Breast Cancer Intrinsic Subtyping Assay to measure the expression levels of the 50 genes of PAM50 in formalin-fixed paraffin-embedded tissue samples. NanoString will collaborate with breast cancer researchers to clinically validate the gene signature on its nCounter Analysis System, it said.

The company added that it plans to seek regulatory approval for the assay from the US Food and Drug Administration and other agencies outside the US.

In a statement, Brad Gray, president and CEO of NanoString, said the firm believes 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."

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