PITTSFIELD -- Nuclea Biotechnologies has entered into a research agreement with one of the world's largest science research companies, and developed a kit that has been approved by the Food and Drug Administration.
The kit, developed by Nuclea's subsidiary, Nuclea Diagnostics of Cambridge, has met the FDA's requirements for its Fatty Acid Synthase (FAS) Immunohistochemistry (IHC) Kit as a Class I in vitro diagnostic (IVD) device.
The FDA defines Class I IVD devices as low to moderate risk devices that are subject to good manufacturing practice regulations, facility registration and device listing with the FDA. FAS is used to measure the metabolism of cells in both oncology and metabolic diseases.
Obtaining FAS IHS results provides physicians with additional data that can be utilized in conjunction with other clinical information to design and optimize personalized treatment strategies for patients.
Nuclea, which has offices in Pittsfield, Worcester and Cambridge, develops and commercializes diagnostic tests for the treatment of colon, breast, leukemia, lung and prostate cancer. The company is also performing research leading to molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries.
Nuclea's FAS Synthase Immunohistochemistry Kit will be available as a Class I IVD test in Nuclea's CLIA laboratory in Pittsfield in October.
"The FDA status of the Nuclea FAS IHS Kit as a Class I IVD demonstrates the organizational expertise concerning out GMP manufacturing facility, our regulatory affairs and our clinical validation groups," said Nuclea President and CEO Patrick J. Muraca in a statement.
Nuclea's research agreement is with Thermo Fisher Scientific Inc., a world leader in serving science, that has $17 billion in revenue and 50,000 employees in 50 countries. Based in Waltham, Thermo Fisher Scientific helps its customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.
The two companies are pooling their resources to develop novel multiplexed research methods for high-throughput quantification of native insulin and its therapeutic analogs. Monitoring the levels of these markers may be useful in predicting the response to therapy for Type 2 diabetes.
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