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) on key QUANTA Flash assays for use with Inova Diagnostics' BIO-FLASH chemiluminescent analyzer for autoimmune testing.
Several QUANTA Flash extractable nuclear antigen (ENA) assays, which are used to aid in the diagnosis of Connective Tissue Diseases (CTD) such as Systemic Lupus Erythematosus, Sjogren's Syndrome and Systemic Sclerosis, received FDA clearance. This adds QUANTA Flash Ro60, Ro52 and SSB to the menu of ENA assays previously cleared by the FDA for use with BIO-FLASH, including QUANTA Flash Sm, RNP, Centromere, and ENA7 assays.
In addition, Inova Diagnostics announced the FDA clearance of QUANTA Flash Beta-2 Glycoprotein1 Domain1 (Beta-2GP1 Domain1), a novel marker for antiphospholipid syndrome (APS). QUANTA Flash Beta-2GP1 Domain1 is a highly specific marker which, in conjunction with clinical and other laboratory findings, aids in the diagnosis of APS. The assay is not intended to replace tests for antibodies against the whole Beta-2GP1 molecule. Testing for antibodies to the whole Beta-2GP1 molecule is required according to the classification criteria for APS.
Professor Munther Khamashta of The Rayne Institute, St. Thomas' Hospital in London, commented, "Since the discovery of this disease by Professor Graham Hughes in 1983, numerous breakthroughs have helped save lives and reduce childbirth complications for those suffering from antiphospholipid syndrome. This latest breakthrough in the availability of a test for Domain 1 will help doctors identify those patients who need the most critical care and are at greatest risk of thrombotic events such as stroke."
With the clearance of these assays, the QUANTA Flash family now includes 22 FDA cleared and 29 CE marked tests available on the BIO-FLASH fully automated chemiluminescent platform. In addition to ENA and APS assays, the menu for BIO-FLASH also includes tests for Celiac Disease and Vasculitis.
According to Claudia Ibarra, Vice President of Laboratory Operations and Thierry Dervieux, Chief Scientific Officer at Exagen Diagnostics, an autoimmune reference laboratory accredited by the College of American Pathologists, "The announced FDA clearance for these assays means that clinical laboratories can now take advantage of the benefits of this powerful system. We have had BIO-FLASH running in our lab for over 10 months. We are very satisfied with the performance, as it allows us to run these markers more efficiently."
Roger Ingles, Chief Executive Officer of Inova Diagnostics, commented, "We are excited about providing customers with a greatly expanded menu on BIO-FLASH. The random access capabilities of BIO-FLASH delivers enhanced workflow efficiencies and improves turn-around time, making even the most specialized autoimmune tests efficient to perform. The addition of QUANTA Flash Beta-2GP1 Domain1 to the BIO-FLASH menu provides a novel marker to support patient care in a very challenging disease."