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NanoString to Develop Companion Dx for Celgene Lymphoma Drug Study

NEW YORK (GenomeWeb) – NanoString Technologies said after the close of the market Tuesday that it will develop a companion diagnostic test for Celgene's Revlimid (lenalidomide), which the firm is developing for diffuse large B-cell lymphoma.

NanoString said that it will develop the in vitro diagnostic assay for use on its nCounter Analysis System. The assay will be used to screen patients who are being enrolled in a pivotal study of Revlimid for the treatment of DLBCL.

Following completion of the study, NanoString will seek regulatory approval of the assay in key global markets. It also may independently develop and commercialize additional indications for the IVD assay.

Under terms of the deal, NanoString could receive payments totaling $45 million from Celgene, of which $5.75 million is in the form of an upfront payment. It could receive $17 million based on developmental and regulatory milestones, and the remainder would be based on potential commercial payments. NanoString noted that it "may receive potential commercial payments in the event sales of the IVD do not exceed certain pre-specified minimum annual revenues during the first three years following regulatory approval."

In January researchers associated with the Lymphoma/Leukemia Molecular Profiling Project published a paper in the journal Blood describing the development and validation of a biomarker assay based on a 20-gene expression DLBCL subtype classifier using NanoString's nCounter Analysis System. NanoString said that it has secured the relevant IP to the classifier, which has enabled the collaboration with Celgene.

"Similar to our development of the Prosigna Breast Cancer Prognostic Gene Signature Assay, which is based on the PAM50 gene signature, this new collaboration demonstrates the power of our business model to leverage biomarker discovery and advance the treatment paradigm, bringing the right therapy to the right patient at the right time," NanoString President and CEO Brad Gray said in a statement. "In addition, this collaboration further validates the nCounter Analysis System as the platform-of-choice for development of IVDs based on multi-gene expression assays, as well as the quality of our clinical and regulatory capabilities."

Celgene's Revlimid is already approved in the US for patients previously treated for multiple myeloma, patients with relapsed or refractory mantle cell lymphoma, and for deletion 5q myelodysplastic syndromes.