Nanostring Unveils Its Molecular Diagnostics Strategy

Writing in IN VIVO in December 2009, analysts from Leerink Swann pointed to NanoString Technologies Inc. as one of a handful of analytical assay platform companies to have established themselves in the research area and then grown by developing or acquiring novel content for clinical diagnostics. ( See "Leveraging Assay Platforms To Create Category-Killer Diagnostic Tests," IN VIVO , December 2009 Also see "Leveraging Assay Platforms to Create Category-Killer Diagnostic Tests " - In Vivo, 1 December, 2009..) At the time, NanoString had not disclosed the specific nature of those tests. But the start-up had begun discussions with a group of academic collaborators who had formed a company, Bioclassifier LLC, to license a gene expression signature for "intrinsically subtyping" breast tumors. The Bioclassifier team had been working on establishing the clinical utility of its test, called PAM50, for the better part of a decade, using microarrays and quantitative PCR (qPCR) technologies. Now, NanoString will commercialize PAM50 to run on its nCounter analysis system. And unlike other molecular diagnostic tests for guiding breast cancer therapy, such as Genomic Health Inc.'s Oncotype Dx or Agendia BV's MammaPrint, which are performed in specialty CLIA labs run by their developers, PAM50 will be broadly distributed to hospitals and pathology laboratories globally.

nCounter analyzes individual molecules in a single reaction without the need for amplification, using a digital gene expression technology developed...