FDA Approves New Kidney Disease ID Test
Test helps detect if cause is autoimmune or infection.
A new test that helps doctors identify the cause of a specific type of kidney disease has been approved by the U.S. Food and Drug Administration.
Membranous glomerulonephritis (MGN) damages blood vessels in the kidneys that help filter the blood. Some cases are caused by the body's rejection of its own kidney tissue (autoimmune), while the rest are triggered by other causes such as infection, the FDA said in a news release.
The Euroimmun Anti-PLA2r IFA test detects an antibody that is present if the cause of MGN is autoimmune, the FDA said.
In a clinical study of 560 blood samples, the test detected autoimmune cases of MGN in 77 percent of samples donated by people presumed to have this form, the agency said.
The test should not be the sole determinant of MGN's cause, nor should a negative test rule out a specific cause, the FDA said.
The test is manufactured by Euroimmun US, based in Morris Plains, N.J.