Wilmington, NC. January 1 2014. AccuGenomics, Inc. has licensed its standardized BCRABL test to Nuclea Biotechnologies, Inc., for the treatment of Chronic Myeloid Leukemia. Nuclea will offer the BCRABL test in its CLIA laboratories and manufacture the BCRABL kits for the Northeast market.
The agreement with Nuclea Biotechnologies will soon lead to more effective treatments for those diagnosed with Chronic Myeloid Leukemia (CML). Nuclea will also participate in the co-development and validation of the BCRABL diagnostic assay for bone marrow samples. Nuclea will submit an IVD product to the FDA for approval of the bone marrow samples. After patients receive bone marrow transplants, they need to be continuously monitored. AccuGenomics standardized BCRABL test is able to monitor efficiency of treatment, residual disease, and disease relapse in those CML patients with a BCRABL MBCR fusion gene event between oncogenes. Currently, there is a dry test available on the market. However, the BCRABL test is chromosomal, and provides faster and more accurate results than other tests currently available.
“The partnership with AccuGenomics highlights the breadth of services Nuclea now provides,” said Patrick Muraca, President and CEO of Nuclea. “Nuclea will manufacture the kits, market the assay, and include the test in our portfolio offered through our CLIA lab. For these reasons, working with AccuGenomics was an attractive opportunity for us.”
The co-development agreement for our standardized BCRABL 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 expertise aligned with a cutting edge oncology laboratory offering the standardized BCRABL test utilizing our proprietary standardized nucleic acid quantification (SNAQ) technology to the Northeast market.” “The relationship with Nuclea is a significant step forward as we look to partner with biopharma and select platform companies with our proprietary Internal Standards mixtures for future development of companion diagnostics.”
Nuclea Biotechnologies, Inc. — is headquartered in Pittsfield, Massachusetts with additional operations in Worcester and Cambridge, Massachusetts. Nuclea has developed and is commercializing unique diagnostic tests for colon, breast, leukemia, lung and prostate cancer. Nuclea also performs research leading to novel molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries. http://www.nucleabio.com