US FDA Approves NephroScan for Preparation of Tc-99m DMSA
Theragnostics has received US FDA approval for NephroScan, a proprietary kit for the preparation of technetium Tc-99m succimer injection for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates. It is manufactured by ROTOP Pharmaka GmbH in Germany and GE Healthcare is the exclusive distributor of the product in the US.
Greg Mullen, President and Chief Executive Officer of Theragnostics, said, “The FDA approval of NephroScan is a significant milestone for Theragnostics and for patients who are affected by kidney disease. NephroScan enables the detection and diagnosis of kidney disease, enabling physicians, patients, and their families to help make informed treatment decisions. The approval has been a remarkable team effort in collaboration with the regulatory development group at Facet Life Sciences and the specialists for radiopharmaceutical development and manufacturing at ROTOP Pharmaka GmbH.”
Dr. Ted Treves, Professor of Radiology at Harvard Medical School and former Chief Division of Nuclear Medicine at Boston Children’s Hospital said,“The value of Tc-99m DMSA is well established in the assessment of disorders affecting the kidneys in children and adults. The approval in the US means that Tc-99m DMSA imaging will be brought back as a useful tool for the evaluation of adult and pediatric patients affected by renal diseases. Efforts are underway for renewed education of referring physicians about its value and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) practice guidelines have recently been updated.”
Following intravenous administration, Tc-99m DMSA (Tc-99m dimercaptosuccinic acid) principally binds to the cortical regions of the kidneys. Its biodistribution makes it a logical imaging agent for renal scintigraphy. It is imaged by different methods such as planar and pinhole imaging and SPECT. Tc-99m DMSA imaging during acute renal infection has been used to identify patients that are at risk for later development of permanent sequalae such as parenchymal scarring, hypertension, and even chronic renal failure. Tc-99m DMSA imaging can also be used for the determination of split renal function, kidney shape, size, position, and homogeneity.