San Diego, CA, US – Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash^® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA). These chemiluminescent assays complement Inova Diagnostics previously cleared QUANTA Flash CCP3 assay that detects anti-citrullinated peptide antibodies (ACPA) and expands the number of FDA-cleared assays available on BIO-FLASH^®, a random access chemiluminescent system.

Rheumatoid arthritis (RA) affects approximately one percent of the global population and leads to progressive and permanent joint damage. The American College of Rheumatology and the European League Against Rheumatism classification criteria include both RF and ACPA. RF IgM has been reported to be the main RF isotype in confirmed RA patients with a prevalence of 70-80%. RF IgA, while less prevalent than the IgM isotype, has been reported to be associated with more severe erosive disease and an increased likelihood for Sjӧgren’s Syndrome or other extra-articular manifestations. There is also value in testing for multiple RF isotypes as the specificity and predictive value for RA increases when more than one isotype is positive.

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 RF IgM and IgA Assays

QUANTA Flash RF IgM and RF IgA are chemiluminescent immunoassays used in human sera, and are indicated for the quantitative determination of IgM RF antibodies, and the semi-quantitative determination of IgA RF antibodies, respectively. The presence of IgM or IgA anti-RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of RA.

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. © 2019 Inova Diagnostics, Inc. All rights reserved.

690657 rev. 0 May 2019