6 August 2020 - - Japanese holding company H.U. Group Holdings, Inc's Fujirebio Diagnostics, Inc subsidiary has initiated clinical testing needed for the submission of its new SARS-CoV-2 Antigen assay for EUA (Emergency Use Authorization) from the US Food and Drug Administration, the company said.

As a provider of immunoassays to the diagnostic industry, Fujirebio, as a global team, is joining the fight to combat the COVID-19 pandemic with the goal of providing 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 robust, 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.

Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio Holdings, Inc., is a cancer diagnostics company and a specialist in cancer biomarker assays.

The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago.

Fujirebio Diagnostics specialises in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

Fujirebio is in the field of in-vitro diagnostics testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Fujirebio is a consolidated subsidiary of H.U. Group Holdings, Inc. (TYO: 4544) and employs more than 1,200 people in Asia, Europe and America.