FDA approves new diagnostic imaging agent Netspot to diagnose rare neuroendocrine tumors
FDA approves new diagnostic imaging agent Netspot to diagnose rare neuroendocrine tumors June 08, 2016 Source: Bio Valley The US Food and Drug Administration (FDA) recently approved a new diagnostic imaging agent, Netspot, from Advanced Accelerator Application USA to detect rare neuroendocrine tumors (NETs). Netspot is the first gallium 68DOTATATE injection, a radioactive diagnostic preparation for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with rare somatostatin receptor-positive neuroendocrine tumors (NETs). Neuroendocrine tumors (NETs) are a rare class of non-cancerous (benign) or cancerous (malignant) tumors that are formed in hormone-producing cells in the human neuroendocrine system. These cells are found throughout the body, including the stomach, intestines, pancreas, lungs, and other areas. NETs have receptors for somatostatin, a hormone that helps regulate the endocrine system. Ga 68 dotatate is a positron emission mimetic of somatostatin that works by binding to such receptors. Libero Marzella, director of the FDA's Center for Drug Evaluation and Research, said that the use of advanced imaging techniques to diagnose rare neuroendocrine tumors (NETs) at an early stage is critical. Netspot will provide a new diagnostic tool that will help clinicians determine the location and extent of the tumor. This information is very important for developing an appropriate treatment plan. NetSpot is a single-dose gallium 68 DOTATATE kit for sterile, intravenous injection. Previously, the product had received FDA's priority review status and orphan drug status. The absorption level of Ga 68 dotatate reflects the density of somatostatin receptors in neuroendocrine tumors (NETs). This absorption can also be observed under other types of tumors or other case conditions, and absorption of Ga 68 dotatate may need to be determined by histopathology or other assessment measures. The safety and effectiveness of Netspot was confirmed in three studies. The results of all three studies confirmed the effectiveness of Ga 68 dotatate imaging in finding neuroendocrine tumors (NETs). Body Lotion,Vaseline Lotion,Body Moisturizer,Body Cream Guangzhou Lingxue Cosmetics Co., Ltd , https://www.gzlxgj188.com