FDA clears test to detect antibodies to HMGCR

September 2018—Inova Diagnostics announced FDA clearance of its Quanta Flash HMGCR for use on its Bio-Flash random access chemiluminescent system. Quanta Flash HMGCR is a semiquantitative chemiluminescence immunoassay for the determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy.

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