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FDA Approves First-of-Kind Kidney Disease Test in 62 Days


Posted in Regulatory and Compliance by Jamie Hartford on July 1, 2014

It's the first test that can help determine if membranous glomerulonephritis is due to the body’s rejection of its own kidney tissue or another cause, like an infection. 


FDA has approved in 62 days a EuroImmun de novo petition to allow marketing of its Anti-PLA2R IFA blood test, the first test that can help determine if a specific type of kidney disease is due to the body’s rejection of its own kidney tissue or another cause, like an infection.

Membranous glomerulonephritis (MGN) is a chronic kidney disease that causes damage to the cluster of blood vessels in the kidney that filter blood and begin the process to remove waste and excess fluid from the blood.

Approval was based on FDA’s review of a clinical study involving 560 blood samples, of which 275 samples were obtained from patients with presumed primary MGN (pMGN), according to an FDA news release. “The test was able to detect pMGN in 77% of the presumed pMGN samples, and gave a false positive result in less than 1% of the other disease samples,” it says.

—Jim Dickinson is MD+DI's contributing editor.

[image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET] 


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