Diasorin Simplexa COVID Direct Kit Receives FDA 510(k) Clearance

DiaSorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa COVID-19 Direct kit. 

The kit provides a sample-to-answer test for the detection of SARS-CoV-2, the virus that causes COVID-19, directly from nasopharyngeal or nasal swab specimens. The Simplexa COVID-19 Direct kit is designed for use on the LIAISON MDX system. 

This COVID-19 molecular assay can be utilized by hospital or commercial laboratories allowing for timely testing and highly accurate results. 

To date, the COVID-19 pandemic has caused over half a billion cases worldwide and over 6 million deaths, according to the World Health Organization. It is important to ensure COVID-19 testing capacity at hospitals and commercial facilities across the nation after the FDA Emergency Use Authorization period has ended, to maintain vigilance post-pandemic against SARS-CoV-2 infections. The Simplexa COVID-19 Direct kit will ensure a high standard of diagnostic testing in order to help mitigate future potential impacts of this virus, according to the company. 

The Simplexa COVID-19 Direct kit differs from other automated PCR assays with extraction as it does not require sample pre-treatment, enabling a fast time-to-result, ultimately allowing prompt decision making regarding isolation and treatment of infected patients. The test is highly specific for SARS-CoV-2 and targets two regions of the viral genome to minimize the impact of mutations on the kit performance with SARS-CoV-2 and potential variants of concern. 

This ensures the results remain highly sensitive and specific, providing confidence in diagnostic decision making. 

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under Contract No. 75A50121P00007. 

DiaSorin says it remains at the forefront of the fight against the spread of SARS-CoV-2 with a suite of COVID-19 molecular diagnostic products, including the Simplexa SARS-CoV-2 Variants Direct (RUO) and has submitted to FDA for review the Simplexa COVID-19 & Flu A/B Direct assay for differential diagnosis during the flu season. 

“The FDA 510(k) clearance of our COVID-19 test demonstrates our commitment to commercialize products featuring the highest standards of diagnostic testing against COVID-19 and other respiratory pathogens,” says Angelo Rago, president of Luminex. “The Simplexa COVID-19 Direct Kit will provide a higher level of confidence enabling clinicians to make effective diagnostic decisions with rapid and accurate results.”