FDA allows marketing of non-invasive test to help in identifying cause of certain kidney disease

June 2, 2014

The U.S. Food and Drug Administration (FDA) has allowed marketing of the first test that can help determine if a specific type of kidney disease, membranous glomerulonephritis (MGN), is due to the body’s rejection of its own kidney tissue (autoimmune) or due to another cause (such an infection).

Membranous glomerulonephritis (MGN) is a chronic kidney disease that causes damage to the cluster of blood vessels (glomeruli) in the kidney that filter the blood and begin the process of removing waste and excess fluid from the blood. Symptoms of MGN include swelling, high cholesterol, high blood pressure, and increased predisposition to blood clots. Over time, usually 10 to 20 years, some people with MGN proceed to kidney failure and require a kidney transplant. MGN affects mostly adult white men.

Some cases of MGN are associated with secondary conditions such as infections or tumors, adverse reactions to drugs, or poisoning. However, about 85% of MGN cases are caused by the body’s immune system mistakenly attacking healthy kidney tissue, a condition called primary MGN (pMGN).

The EUROIMMUN Anti-PLA2R IFA blood test detects whether a patient has an antibody specific to pMGN. The FDA reviewed the test through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind.

The review included a clinical study of 560 blood samples; 275 samples were obtained from patients with presumed pMGN, while 285 were obtained from patients diagnosed with other kidney diseases and autoimmune diseases that can damage the kidney. 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 was helpful in distinguishing between pMGN and sMGN in most patients. Learn more about this assay.

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