Fujirebio Diagnostics initiates clinical testing for coronavirus assay
The company has begun testing needed for the submission of its new Lumipulse SARS-CoV-2 Antigen assay for Emergency Use Authorization from the U.S. Food and Drug Administration
MALVERN, Pa.—Fujirebio Diagnostics Inc., a consolidated subsidiary of H.U. Group Holdings Inc., announced recently the initiation of clinical testing needed for the submission of its new SARS-CoV-2 Antigen assay for EUA (Emergency Use Authorization) from the U.S. Food and Drug Administration.
The company’s goal, as a leading provider of immunoassays to the diagnostic industry, is to join the fight to combat the COVID-19 pandemic with what it hopes will be the first fully automated antigen test.
The Lumipulse SARS-CoV-2 Antigen assay will be available for use on the LUMIPULSE G1200 instrument. The LUMIPULSE G1200 is a fully automated CLEIA (chemiluminescent enzyme immunoassay) immunoassay instrument. The LUMIPULSE G1200 has a throughput of 120 tests per hour and allows laboratory personnel to randomly load samples as needed. CLEIA technology and automated testing provides increased sensitivity, reproducibility and throughput over single-use point-of-care tests.
On June 19, Fujirebio Inc. (Tokyo) received Japanese regulatory approval of the SARS-CoV-2 Antigen assay for use with nasopharyngeal and saliva samples. The assay is available in Japan as a stand-alone detection tool for the presence of SARS-CoV-2 virus.
The initial submission to the FDA is expected to be made in early September for nasopharyngeal swab in universal viral transport media. Submissions to expand sample types are expected to follow.
“As the first company to develop a fully automated SARS-CoV-2 antigen test, we expect this innovation to have a positive impact on result turnaround times and laboratory throughput of COVID-19 testing,” said Monte Wiltse, president and CEO at Fujirebio Diagnostics Inc.