FDA has granted premarket notification (510(k)) clearance to the Quanta Flash HMGCR semiquantitative chemiluminescence immunoassay by Inova Diagnostics, a San Diego-based provider of autoimmune disease diagnostic systems and reagents for the clinical laboratory.
Available exclusively from Inova Diagnostics, the Quanta Flash 3-hydroxy-3 methylglutaryl-coenzyme A reductase (HMGCR) assay detects the presence of IgG autoantibodies against HMGCR antigen in human serum.
The Quanta Flash HMGCR immunoassay aids in the diagnosis of idiopathic inflammatory myopathy (IIM), a group of musculoskeletal conditions that can result in progressive muscle weakness and lead to tissue necrosis and disability in some cases.
“In 2010, our team at Johns Hopkins discovered autoantibodies to HMGCR in a group of patients with immune-mediated necrotizing myopathy (IMNM),” says Andrew Mammen, MD, PhD, cofounder of the myositis center at Johns Hopkins University, codiscoverer of HMGCR, and leader of the muscle disease unit at the National Institute of Arthritis and Musculoskeletal and Skin Disease.
“HMGCR is the pharmacological target of statins, and a subgroup of our patients had experienced statin-associated myopathy,” says Mammen. “The presence of antibodies to HMGCR was found to be highly specific to myositis, and is associated with, but not limited to, statin exposure.”
“The importance of anti-HMGCR testing is highlighted by the association of IMNM with statin exposure. Statins are found in a number of foods but are also a family of the most commonly prescribed drugs used to lower blood cholesterol,” notes Marvin Fritzler, PhD, MD, professor of medicine at the University of Calgary and director of the school’s mitogen advanced diagnostics laboratory. “Although side effects related to statin exposure are usually self-limited, in some rare instances individuals may develop autoantibodies that recognize HMGCR and a necrotizing autoimmune myopathy (eg, IMNM). Testing for these antibodies may help differentiate those with self-limited myopathy who recover after statin discontinuation from those with progressive disease who are at risk of severe morbidity and often require aggressive immunosuppressive therapy.”
The Quanta Flash HMGCR immunoassay is one of 30 FDA-cleared assays available on Bio-Flash, Inova Diagnostics’ random-access chemiluminescent instrument. Inova is a privately held company that is a part of Werfen, an in vitro diagnostics company based in Barcelona.
For more information, visit Inova Diagnostics.