Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR
San Diego - August 14, 2018
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the clearance of QUANTA Flash® HMGCR by the US Food and Drug Administration (FDA). HMGCR is a marker exclusively available from Inova Diagnostics, and is one of 30 FDA-cleared assays available on BIO-FLASH®, a random access chemiluminescent system. QUANTA Flash HMGCR aids in the diagnosis of idiopathic inflammatory myopathy (IIM). IIM is a group of conditions that affect the skeletal muscles which can result in progressive muscle weakness, in some cases leading to tissue necrosis and disability.
Andrew Mammen, MD, PhD, co-founding member of the Johns Hopkins Myositis Center, co-discoverer of autoantibodies recognizing 3-hydroxy-3 methylglutaryl-coenzyme A reductase (HMGCR), and Leader of the Muscle Disease Unit at the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases commented, "In 2010 our team at Johns Hopkins discovered autoantibodies to HMGCR in a group of patients with immune-mediated necrotizing myopathy (IMNM). HMGCR is the pharmacological target of statins, and a sub-group of our patients had experienced statin-associated myopathy. The presence of antibodies to HMGCR was found to be highly specific to myositis, and is associated with, but not limited to statin exposure."
Marvin Fritzler, PhD, MD, Professor of Medicine at the University of Calgary; Director of the Mitogen Advanced Diagnostics Laboratory commented, "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. 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 (e.g. 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."
About Inova Diagnostics, Inc.
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease, and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
About QUANTA Flash HMGCR
QUANTA Flash HMGCR is a semi-quantitative chemiluminescence immunoassay performed on the BIO-FLASH instrument for the determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme 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 (IIM).
BIO-FLASH is a random access chemiluminescent instrument for the autoimmune laboratory which delivers results in as little as 30 minutes. BIO-FLASH offers a wide analytical measuring range and precise quantification for greater confidence in results, and is a progressive step forward to handle routine, specialized and STAT immunology tests.
BIO-FLASH is a registered trademark of Biokit S.A. and QUANTA Flash is a trademark of Inova Diagnostics, Inc. © 2018 Inova Diagnostics, Inc. All rights reserved.
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