Nuclea Signs Two Partnership Agreements, Expands Service Offerings to Include New Laboratory Developed Tests

January 13, 2014

Pittsfield, MA – As Nuclea closed out a year of rapid growth, it signed two development deals that will expand its service offering to include CLIA validation. The deals signed with AccuGenomics, Inc. and Nuvera Biosciences, Inc. will include validating two new assays in the treatment of Chronic Myeloid Leukemia and breast cancer. The deals include the manufacturing and selling of kits for one assay, and offering both assays in their CLIA laboratory. These agreements mark Nuclea’s rapid growth into CLIA laboratory developed tests.

The agreement with AccuGenomics, Inc. will soon lead to more effective treatments for those diagnosed with Chronic Myeloid Leukemia (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. The pairing of these two leaders in the fields of diagnostics and monitoring will accelerate the timeframe for making this test available.

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 will also 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.

“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 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 expertise aligned with a cutting edge oncology laboratory offering the standardized  BCR-abl test utilizing our proprietary 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 for future development of companion diagnostics.”

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 in February.

“Our agreement with Nuvera is a strong addition to our work on breast cancer,” said Patrick Muraca of Nuclea. “As the medical community moves toward more personalized medicine. Nuvera’s assay is a great prognosis tool for oncologists evaluating taxane or endocrine therapy for their breast cancer patients.”


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
 
AccuGenomics -- is a diagnostic company focused on developing standardized molecular diagnostic tests in oncology utilizing its patented standardized SNAQ technology. These tests will generate disease specific data that provide accuracy and intrinsic quality control for patient solutions. Additional information: www.accugenomics.com

Nuvera Biosciences -- is focused on developing novel molecular diagnostics that make a significant impact on cancer care by improving detection techniques and treatment selection in cancer. Nuvera's diagnostic development is based on multi-gene profiling in prospective treatment-specific trials through collaboration with leading cancer centers worldwide. www.nuverabio.com

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