NanoString Technologies, Inc., a provider of life science tools for translational research and molecular diagnostic products, has entered into a collaboration with Celgene Corporation to develop a companion diagnostic assay using the nCounter Analysis System to support the clinical validation of REVLIMID for treatment of Diffuse Large B-Cell Lymphoma (DLBCL).
DLBCL is a heterogeneous group of cancers classified together on the basis of morphology, immunophenotype, genetic alterations, and clinical behavior, that represents the most common form of non-Hodgkin lymphoma. According to the National Cancer Institute, DLBCL will represent approximately 37% of the 70,000 new cases of non-Hodgkin lymphoma this year. The subtypes of DLBCL have long been known to have varying prognoses. Accordingly, the accurate and precise assignment of subtype has the potential to become increasingly important with the emergence of novel therapies, and repurposing of existing products, that have selective clinical activity in specific subsets of patients.
Under the collaboration agreement with Celgene, NanoString will work to develop an in vitro diagnostic (IVD) companion test to REVLIMID that will be used to screen patients who are being enrolled in a pivotal study of REVLIMID for the treatment of DLBCL. Upon successful completion of the study, NanoString will pursue regulatory approval of the IVD in key global markets. Pursuant to the terms of the agreement, NanoString retains the flexibility to independently develop and commercialize additional indications for the IVD assay.
“Biomarker-driven clinical trials are the future of clinical oncology. The nCounter platform is expected to enable reproducible subtyping of patients in our pivotal REVLIMID DLBCL study and will form the basis for companion diagnostic development,” says Jean-Pierre Bizzari, Executive Vice President of Clinical Development at Celgene. Read the press release frm NanoString.
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