The clinical testing is aimed at supporting the regulatory submission for the US Food and Drug Administration (FDA) emergency use authorisation (EUA)
Fujirebio Diagnostics, a subsidiary of Fujirebio Holdings, has begun clinical testing of its new Lumipulse SARS-CoV-2 Antigen assay, used on the LUMIPULSE G1200 device.
The company said that the clinical study is aimed at supporting the regulatory submission for the US Food and Drug Administration (FDA) emergency use authorisation (EUA).
Engaged in conception, development, production and worldwide commercialisation of in-vitro diagnostics (IVD) products, Fujirebio has developed the fully automated antigen test to help the fight against Covid-19.
Fujirebio Diagnostics president and CEO Monte Wiltse said: “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.”
Lumipulse SARS-CoV-2 Antigen assay is used on LUMIPULSE G1200 device
The LUMIPULSE G1200 is a fully automated diagnostic device that facilitates chemiluminescent enzyme immunoassay (CLEIA). The device is capable of running 120 tests per hour, allowing laboratory technicians randomly load samples as needed.
The company said that the CLEIA technology, combined with automated testing, would provide enhanced sensitivity, reproducibility and throughput compared to single-use point-of-care tests.
Fujirebio has secured Japanese regulatory approval for its new SARS-CoV-2 Antigen assay in June 2020, for use with nasopharyngeal and saliva samples, and is available in Japan as a stand-alone diagnostic tool to detect the SARS-CoV-2 virus.
The company is expected to make the initial submission to the FDA for nasopharyngeal swab in universal viral transport media, in early September 2020, with additional submissions to expand the sample types in future.
In June 2018, Fujirebio secured FDA for its Lumipulse G B•R•A•H•M•S procalcitonin (PCT) assay for testing on Lumipulse G1200 immunoassay platform.