FDA allows first test into market to determine cause of kidney disease
- FDA is allowing EUROIMMUN, a NJ-based company, to market a test to determine whether a specific kidney disease---MGN--- is autoimmune or secondary to other factors.
- MGN, or membranous glomerulonephritis, is a chronic kidney disease that can progress to kidney failure.
- Being able to diagnose the underlying causes of the disease can help guide treatment.
EUROIMMUN, based in Morris Plains, NJ, has developed an antibody-based test that can determine whether a patient’s MGN is autoimmune or caused by other factors, such as infection, an adverse reaction to a drug or a tumor. In 85% of cases, it is autoimmune. The name of the test is the EUROIMMUN Anti-PLA2R IFA blood test. It was FDA-reviewed through the de novo classification process---a regulatory pathway reserved for certain low- to moderate-risk medical devices.