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RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.

Houston, TX and St. Louis, MO, Sept. 07, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that DetectnetTM (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA).  Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.  Curium expects to launch Detectnet immediately with doses available through various nuclear pharmacies, or directly from Curium.  


Detectnet brings an exciting advancement in the diagnosis of neuroendocrine tumors for healthcare providers, patients, and their caregivers,” said Ebrahim Delpassand, MD, CEO of RadioMedix.  “The Phase III results demonstrate the clinical sensitivity and specificity of Detectnet which will provide a great aid to clinicians in developing an accurate treatment approach for their NET patients.  Perhaps, what is most exciting is that the 12.7-hour half-life allows Detectnet to be produced centrally and shipped to sites throughout the U.S.  This will help alleviate shortages or delays that have been experienced with other somatostatin analogue PET agents.”


Curium is excited to bring the first commercially available Cu 64 diagnostic agent to the U.S. market.  Our unique production capabilities and distribution network allow us to deliver to any nuclear pharmacy, hospital or imaging center its full dosing requirements first thing in the morning, to provide scheduling flexibility to the institution and its patients,” said Curium CEO, North America, Dan Brague.  “We look forward to joining with healthcare providers and our nuclear pharmacy partners to bring this highly efficacious agent to the market.”


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Source: RadioMedix