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Blue Earth Diagnostics Ltd.
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Blue Earth Diagnostics, a molecular imaging diagnostics company, announced it has established operations in the United States in Burlington, Mass.
Blue Earth Diagnostics Ltd (BED) announced it has received both U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Orphan Drug Designation (ODD) for fluciclovine (18F) in the diagnosis of glioma. Fluciclovine is an investigational positron emission tomography (PET) radiopharmaceutical based on a synthetic amino acid, which appears to be preferentially taken up in a number of cancer indications, including in prostate cancer and brain tumors.
Siemens’ PETNET Solutions Inc. has entered into a nationwide agreement with U.K.-based Blue Earth Diagnostics Ltd. for the exclusive commercial manufacturing and distribution of Fluciclovine (18F), an investigational positron emission tomography and computed tomography (PET/CT) radiopharmaceutical. Fluciclovine (18F) is being studied for prostate imaging in clinical trials conducted in the United States, Japan, Italy, Norway, Sweden and Finland. The F-18-based radiopharmaceutical has a long half-life, which may facilitate its geographical distribution to clinical trial sites and then to clinical imaging centers once it gains approval from the U.S. Food and Drug Administration (FDA).