The US Food and Drug Administration (FDA) has granted 510(k) approval for Inova Diagnostics’ Quanta Flash connective tissue disease assays.
The Quanta Flash assays have received approval for use with the firm’s Bio-Flash chemiluminescent analyzer for autoimmune testing.
Several Quanta Flash extractable nuclear antigen (ENA) assays are said to be used to diagnose connective tissue diseases (CTD) such as Systemic Lupus Erythematosus, Sjogren’sSyndrome and Systemic Sclerosis.
The approval allows to add 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.
The company has also obtained FDA approval for Quanta Flash Beta-2 Glycoprotein1 Domain1 (Beta-2GP1Domain1), a new marker for antiphospholipid syndrome (APS).
The new marker, along with clinical and other laboratory findings, helps in the diagnosis of APS. It is not intended to replace tests for antibodies against the whole Beta-2GP1 molecule.
Inova Diagnostics CEO Roger Ingles said: "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 Beta-2GP1 Domain1 to the BIO-FLASH menuprovides a novel marker to support patient care in a very challenging disease."
Image: Autoimmune chemiluminescent analyzer. Photo: courtesy of PRNewswire/Inova Diagnostics.