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Nuclea Signs MDx Development Deals with AccuGenomics, Nuvera

NEW YORK (GenomeWeb News) – Nuclea said today that it has signed agreements with AccuGenomics and Nuvera Biosciences covering co-development of molecular diagnostics for chronic myeloid leukemia and breast cancer, respectively.

Under the terms of the agreement with AccuGenomics, Nuclea will participate in the co-development and validation of a BCR-ABL test for use in monitoring the efficacy of treatment for CML. Nuclea will manufacture the AccuGenomics BCR-ABL Molecular Diagnostic Kit in its GMP facility, sell research-use-only kits, and offer the test in its CLIA laboratory. Nuclea said it will also develop and submit the test to the US Food and Drug Administration for approval.

In the Nuvera deal, Nuclea will co-develop a gene-based breast cancer assay to predict patient responsiveness to taxane chemotherapy and endocrine therapy for breast cancer. Nuclea said it will develop the assay and secure CLIA validation.

Financial terms of the agreements were not disclosed.

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