Inova Diagnostics receives FDA clearance for QUANTA Flash dsDNA, QUANTA Flash Jo-1, and QUANTA Flash Scl-70
San Diego, CA, US - July 20, 2016
Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the QUANTA Flash dsDNA, Jo-1, and Scl-70 assays.
QUANTA Flash dsDNA is a highly specific marker which, in conjunction with clinical and other laboratory findings, is used to aid in the diagnosis of systemic lupus erythematosus (SLE). QUANTA Flash dsDNA shows excellent sensitivity and specificity for SLE, strong correlation with disease activity parameters such as SLEDAI, C3, C4, and total complement activity. Moreover, QUANTA Flash dsDNA shows correlation to Farr with rapid, safe results. Professor Ban-Hock Toh of Monash University, Melbourne, Australia, commented, "Anti-dsDNA antibodies measured with QUANTA Flash on the fully automated BIO-FLASH analyzer show very high agreement to Farr assay, which is often considered the reference method in spite of the labor intensive procedure and the presence of radioactivity. The QUANTA Flash dsDNA assay is a viable alternative for labs currently using the Farr technology." QUANTA Flash Jo-1 is an important marker for polymyositis and dermatomyositis. QUANTA Flash Scl-70 is a classification marker for systemic sclerosis. With the clearance of these assays, Inova Diagnostics enhances its comprehensive portfolio of myositis and systemic sclerosis markers, respectively.
The QUANTA Flash family now includes 26 FDA cleared and 29 CE marked tests available on the BIO-FLASH fully automated chemiluminescent platform. In addition to CTD and APS assays, the menu for BIO-FLASH also includes tests for Celiac Disease, RA and Vasculitis. According to Michael Mahler, PhD, Vice President of R&D, "We are extremely pleased to launch QUANTA Flash dsDNA and Jo-1 in the United States. Both of these tests are integral to help diagnose SLE and inflammatory myositis, respectively. Accurate and early detection of these antibodies is paramount to the patient receiving the best patient care."
Roger Ingles, Chief Executive Officer of Inova Diagnostics, commented, "We are very excited about the expanded menu of ENA tests on BIO-FLASH. The random access capabilities of BIO-FLASH delivers enhanced workflow efficiencies and improved turn-around time, making even the most specialized autoimmune tests efficient to perform. The addition of QUANTA Flash dsDNA and Jo-1 assays expands the BIO-FLASH CTD menu and will allow laboratories and physicians to receive accurate and timely patient results."
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. BIO-FLASH is a progressive step forward to handle routine, specialized and STAT immunology tests in-house with greater speed and precision than ever before.
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 in vitro diagnostics (IVD) with a long term commitment to providing high quality, innovative solutions for hospitals and clinical laboratories to enhance patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease that are used around the world, and is a leader in the development and commercialization of novel autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
QUANTA Flash is a trademark of Inova Diagnostics, Inc. BIO-FLASH is a trademark of Biokit S.A.
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