SAN DIEGO, Aug. 14, 2018 /PRNewswire/ -- 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).
About BIO-FLASH
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.
690634 rev. 1 Aug 2018
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SOURCE Inova Diagnostics