Pittsfield, Mass.-based Nuclea Biotechnologies has signed two development deals that will expand its service offering to include CLIA validation. The deals signed with AccuGenomics, a diagnostic company focused on developing standardized molecular diagnostic tests in oncology, and Nuvera Biosciences will include validating two new assays in the treatment of chronic myeloid leukemia (CML) and breast cancer. The deals include the manufacturing and selling of kits for one assay, and offering both assays in their CLIA laboratory.
The agreement with AccuGenomics soon will lead to more effective treatments for those diagnosed with CML. Nuclea will participate in the co-development of the BCR-abl diagnostic assay and will validate the test so it can be used in a clinical lab.
Nuclea will manufacture the AccuGenomics BCR-abl Molecular Diagnostic Kit in its new GMP facility, sell the research use only (RUO) kits and offer the test in their CLIA laboratory. Nuclea also will develop and submit an IVD product to the FDA for approval.
After patients receive bone marrow transplants, they need to be continuously monitored. The BCR-abl test is able to monitor efficiency of treatment, residual disease and disease relapse in those CML patients with a BCR-abl MBCR fusion gene event between oncogenes. Currently, there is a dry test available on the market. However, the BCR-abl test is chromosomal, and provides faster and more accurate results than other tests currently available.
“Nuclea will manufacture the kits, market the assay and include the test in our portfolio offered through our CLIA lab,” said Patrick Muraca, president and CEO of Nuclea.
“The co-development agreement for our standardized BCR-abl CLIA test in bone marrow and blood samples with Nuclea is very promising as it relates to our diagnostic strategy,” said Dr. Nick Lazaridis, president of AccuGenomics. “The partnership with Nuclea provides extensive manufacturing experience aligned with a cutting edge oncology laboratory offering the standardized BCR-abl test utilizing our proprietary SNAQ technology to the Northeast market.”
The deal with Nuvera centers on the co-development of their gene-based breast cancer assay which can predict patient responsiveness to taxane chemotherapy and endocrine therapy. The test is a genomic predictor of response and survival following taxane-Anthracycline chemotherapy for invasive breast cancer. The patient response to these treatment options is a tool for the management and monitoring of women with breast cancer.
Nuclea will conduct the development of the assay, along with securing CLIA validation, beginning February.