Studies That Led to FDA Approval of Axumin as Prostate Cancer Imaging Agent Presented at SNMMI 2016

Studies That Led to FDA Approval of Axumin as Prostate Cancer Imaging Agent Presented at SNMMI 2016
Blue Earth Diagnostics Inc. of Burlington, Massachusetts, announced that it is presenting results from studies that led to the recent U.S. Food and Drug Administration (FDA) approval of its molecular imaging agent Axumin (fluciclovine F 18) to identify prostate cancer recurrence. The presentations are taking place at the Society of Nuclear Medicine and Molecular Imaging meeting now underway in California. Axumin is the first F-18 PET imaging agent approved for use in patients with suspected recurrent prostate cancer. Blue Earth Diagnostics (BED)'s chief executive officer, Jonathan Allis, said in a release: "FDA approval of Axumin is a major milestone for BED, as well as for prostate cancer patients and their physicians. We hope Axumin will be the first in a suite of products to assist in the diagnosis of disease. We look forward to Axumin being increasingly available in the coming months in the US via our US vendor and to subsequent global approvals." Axumin is indicated for positron emission tomography (PET) imaging in men in whom prostate cancer recurrence is suspected based on elevated blood prostate specific antigen (PSA) levels following initial treatment for the disease. High PSA in the blood is a sign that cancer is coming back or spreading. PET imaging with Axumin may identify the location and extent of such a recurrence. The Axumin product, which was developed to enable visualization of increased amino acid transport characteristic in many cancers, including prostate cancer, consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F18 for PET imaging — in which a special type of camera and a tracer (radioactive chemical) are
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