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FDA Clears Inova Diagnostics Marker for Statin-Associated Myopathy

NEW YORK (360Dx) –Inova Diagnostics said today that it received clearance from the US Food and Drug Administration for use of the Quanta Flash HMGCR marker, which aids in the diagnosis of idiopathic inflammatory myopathy (IIM), a group of conditions that affect the skeletal muscles and can lead to progressive muscle weakness, including tissue necrosis and disability.

Quanta Flash HMGCR is a semi-quantitative chemiluminescence immunoassay performed on Inova's Bio-Flash instrument for the determination of IgG autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme reductase (HMGCR) antigen in human serum. In conjunction with clinical findings and other laboratory tests, the presence of anti-HMGCR antibodies aid in the diagnosis of IIM.

Andrew Mammen, cofounding member of the Johns Hopkins Myositis Center and who codiscovered autoantibodies that recognize HMGCR, said that the marker is a pharmacological target of statins. In work that led to the discovery of the autoantibodies within a group of patients with immune-mediated necrotizing myopathy in 2010, he and his colleagues noticed that a subgroup experienced myopathy associated with statins. "The presence of antibodies to HMGCR was found to be highly specific to myositis and is associated with, but not limited to, statin exposure," he said in a statement.

The marker is one of 30 FDA-cleared assays available on the Bio-Flash random access chemiluminescent system for the autoimmune laboratory, which delivers results in about 30 minutes, said San Diego-based Inova, which is part of Werfen.