FDA Clears Key Chemiluminescent Assays for Autoimmune Diagnostics

The US Food and Drug Administration (FDA) has cleared for use on the Bio-Flash automated platform several assays for connective tissue diseases (CTDs) and one assay for a novel antiphospholipid syndrome (APS) biomarker.

Inova Diagnostics (San Diego, CA, USA), a leader in autoimmune diagnostics to enhance patient care, has received 510(k) clearance on key “QUANTA Flash” assays for use with the “BIO-FLASH” chemiluminescent analyzer for autoimmune testing. QUANTA Flash extractable nuclear antigen (ENA) assays are used to aid in the diagnosis of CTDs such as Systemic Lupus Erythematosus, Sjogren's Syndrome, and Systemic Sclerosis. The new clearance adds QUANTA Flash Ro60, Ro52, and SSB to the menu previously FDA-cleared ENA assays, including QUANTA Flash Sm, RNP, Centromere, and ENA7 assays.


In addition, Inova received clearance of QUANTA Flash Beta-2 Glycoprotein1 Domain1 (Beta-2GP1 Domain1), a novel, highly specific marker that, 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 APS classification criteria. "Since the discovery of this disease by Prof. Graham Hughes in 1983, numerous breakthroughs have helped save lives and reduce childbirth complications for those suffering from APS. 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," said Prof. Munther Khamashta, Rayne Institute, St. Thomas' Hospital (London, UK). Roger Ingles, CEO, Inova Diagnostics, said, “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.”

QUANTA Flash now includes 22 FDA-cleared and 29 CE-marked tests available on the BIO-FLASH platform. In addition to ENA and APS assays, the menu for BIO-FLASH also includes tests for celiac disease and vasculitis. "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," said Claudia Ibarra, vice president of Laboratory Operations at Thierry Dervieux, and chief scientific officer at Exagen Diagnostics.

BIO-FLASH is an automated, random-access chemiluminescent instrument that delivers results in as little as 30 minutes. It offers the autoimmune clinical laboratory a wide analytical measuring range for handling routine, specialized, and STAT immunology tests in-house with greater speed and precision. "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," said Mr. Ingles.

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