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NanoString, Riken Genesis to Commercialize Diagnostic Assays in Japan

NEW YORK (GenomeWeb) – NanoString Technologies and Sysmex subsidiary Riken Genesis said today that they have entered into a partnership to bring nCounter-based diagnostic assays to the Japanese market. 

Under the agreement, NanoString and Riken will collaborate to commercialize, register, and gain reimbursement for companion diagnostic tests, including a lymphoma subtyping test that  will be marketed as the nCounter Dx LymphMark assay.

LymphMark is a 20-gene signature that classifies cell-of-origin subtypes in patients with diffuse large B-cell lymphoma (DLBCL). Based on a signature called Lymph2Cx, which was originally developed by the Lymphoma/Leukemia Molecular Profiling Project, the test has already demonstrated analytical robustness and potential clinical utility, NanoString said.

In the US, NanoString has a deal with Celgene, in which the same panel has been used to select patients for the firm's Phase III ROBUST trial of Revlimid (lenalidomide). NanoString has said it anticipates filing a PMA this year with the US Food and Drug Administration for a Lymph2Cx-based CDx to the Celgene drug.

The Lymph2Cx assay is also being tested in more than 40 research studies with 23 other companies, NanoString added.

"Through this collaboration, we will work closely with Riken Genesis to launch novel diagnostic products on the nCounter platform that have the potential to guide decision making in the Japanese oncology community," NanoString CEO Brad Gray said in a statement.

Financial terms of the deal were not disclosed.