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Radiodiagnostic Imaging Agent for Kidney Disease Detection Gets FDA Approval


The newly approved NephroScan may have promise in facilitating the diagnosis and assessment of renal disorders.

The Food and Drug Administration (FDA) has reportedly approved NephroScan, a radiodiagnostic imaging drug radiologists may utilize to help detect and assess renal parenchymal disorders.

Theragnostics says the imaging agent, which assists with preparation of the technetium Tc-99m succimer injection, may be utilized in adult and pediatric patients, including term neonates. GE Healthcare will be distributing NephroScan in the United States, according to Theragnostics.

Ted Treves, MD, said the FDA approval is welcome news for assessing patients with kidney disorders.

“The value of Tc-99m DMSA (dimercaptosuccinic acid) is well established in the assessment of disorders affecting the kidneys in children and adults,” noted Dr. Treves, a professor of radiology at Harvard Medical School and former chief of the Division of Nuclear Medicine at Boston Children’s Hospital. “The approval (of NephroScan) in the U.S. 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.”

Theragnostics noted that the biodistribution of Tc-99m DMSA, which principally binds to the cortical regions of the kidneys, “makes it a logical imaging agent for renal scintigraphy.”

In cases of acute renal infection, Theragnostics said TC-99m DMSA imaging has been utilized to identify patients at risk for sequelae including hypertension, parenchymal scarring, and chronic renal failure. Radiologists may also use Tc-99m DMSA imaging to ascertain split renal function, kidney shape and position, according to Theragnostics.

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