Luminex has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its ARIES SARS-CoV-2 Assay.
The ARIES system will be used to run the assay to rapidly detect the virus responsible for COVID-19 disease.
Luminex’s ARIES system is an FDA-cleared, sample-to-answer, automated and on-demand molecular diagnostic platform.
The ARIES system will run up to 144 SARS-CoV-2 tests per day
The ARIES system holds the capacity to run up to 144 tests per day, as well as needs no specialty training and minimal human interaction.
Luminex president and CEO Nachum “Homi” Shamir said: “We are grateful to the FDA for this Emergency Use Authorisation, which allows us to bring another cost-effective SARS-CoV-2 test from Luminex to labs and patients in dire need of quick, accurate results.
“We are scaling up production of this assay over the next three weeks to support hundreds of labs across the US and the rest of the globe. These labs are already operating the ARIES System and should be able to get up and running very quickly as we make this test broadly available.”
Recently, the company also secured EUA status from the FDA for its NxTAG CoV extended panel, a test intended for the detection of the SARS-CoV-2 virus. It also secured medical device authorisation for importation or sale for Health Canada.
The panel is said to be a high-throughput, scalable and cost-effective option to detect SARS-CoV-2 in more than 96 samples in around four hours.
The NxTAG CoV extended panel can also be operated in parallel with the NxTAG respiratory pathogen panel to offer a more complete picture of a patient’s respiratory health
Luminex also said that it has expanded its manufacturing capacity to produce up to 200,000 ARIES SARS-CoV-2 tests per month, as well as up to 300,000 NxTAG tests per month.
The company is providing its testing solution for the laboratories in the US, Asia, and Europe.
