CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 2014—Nuclea signed development deals with AccuGenomics and Nuvera Biosciences that will include validating two new assays in the treatment of chronic myeloid leukemia and breast cancer.
Nuclea will co-develop, with Accu-Genomics, the BCR-abl diagnostic assay, manufacture the molecular diagnostic kit in its new GMP facility, sell the research-use-only kits, and offer the test in its CLIA laboratory. Nuclea will also develop and submit an IVD product to the FDA for approval.
The deal with Nuvera centers on the co-development of its gene-based breast cancer assay, which can predict patient responsiveness to taxane chemotherapy and endocrine therapy. Nuclea will also secure CLIA validation.
Nuclea Biotechnologies, 617-695-0369