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The FDA has approved the listing of the radioactive diagnostic reagent Deteectnet (Cu 64 DOTATATE), developed jointly by RadioMedix and Curium, according to the FDA's official website.
neuroendocrine tumor (NETs) that are positive for growth inhibitor (somatostatin, SST) in adults using a positive electron emission fault scan (PET).
, RadioMedix's press release noted that it was the first diagnostic reagent to match Cu 64 radioisotopes with the growth inhibitor-liked DOTATATE.
NETs are a relatively rare group of tumors that originate from neuroendocrine cells.
2012 U.S. epidemiological data, the incidence of NETs is about 698 per 100,000.
Because neuroendocrine cells are widely distributed throughout the body, including pituitary, thyroid, lung, thymus, gastrointestinal, pancreas, adrenal glands, skin, etc., can secrete hundreds of hormones, so NETs can occur in many organs and tissues in the body, clinical manifestations are complex and variable.
most common sites are the pancreas, gastrointestinal tract, lungs and thymus.
because of the abundance of SST subjects expressed on the surface of NETs cells, the radioactive material-labeled SOTATATE is able to mark the location of the tumor by binding to the SST subject.
in recent years, DOTATATE has been approved for a number of different radioactive markers, which play an important role in tumor diagnosis, station and treatment.
, published this year in the journal Journal of Nuclear Medicine, showed that USC 64 DOTATATE assisted PET imaging showed a sensitivity of 90.9 per cent and specificity of 96.6 per cent in the detection of NETs.
addition, Cu 64 DOTATATE has the advantage of easy mass production and long half-life compared to DOTATATE, which is associated with other radioactive elements, and is expected to enable more physicians to discover NEOTs in a more timely manner with this diagnostic reagent.
References: nDA Approval Letter. Retrieved September 4, 2020, from RadioMedix and Curium Announce copper Cu 64 dotatate injection Was Granted Priority Review by the U.S. FDA. Retrieved September 4, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
