DiaSorin announced “it has received 510 (k) clearance from the US Food and Drug Administration (FDA) for the Simplexa ™ COVID-19 Direct test, a sample-to-answer solution for detecting SARS CoV-2 , the virus that causes COVID-19. The test allows to obtain timely and accurate results, can be performed directly from samples taken via nasal or nasopharyngeal swab and is designed for use on LIAISON® MDX systems installed in hospital or commercial laboratories “.
“According to the World Health Organization – the note continues – the COVID-19 pandemic has caused, to date, over half a billion cases worldwide and over six million deaths. When, however, the pandemic state has ceased and the FDA’s authorization for emergency use of diagnostic tests is revoked, it will be essential to ensure sufficient availability of tests to US hospital and private laboratories, to allow continued surveillance of the evolution of the spread of the virus. In this context, the Simplexa ™ COVID-19 Direct test, thanks to today’s approval, will help mitigate further potential impacts of the SARS-CoV 2 virus. Simplexa ™ COVID-19 Direct differs from other tests available on the market based on the technology PCR, for the possibility of ready use, without the need to pre-treat the sample and for the high speed in detecting the presence of the virus, allowing to make timely decisions regarding the isolation and management of positive patients. The test is also highly specific in identifying two regions of the SARS-CoV-2 genome, minimizing the impact of mutations on its performance and ensuring highly sensitive and specific results, fundamental in the management of the diagnostic decision-making process. This project was funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority pursuant to contract no. 75A50121P00007 “.
“DiaSorin remains at the forefront of the fight against the spread of SARS-CoV-2 with its portfolio of molecular diagnostics products for SARS-CoV-2, including Simplexa ™ SARS-CoV-2 Variants Direct, for exclusive use. research and the recent submission to the FDA of the Simplexa ™ COVID-19 & Flu A / B Direct test for seasonal differential diagnosis.
“The 510 (k) approval of our test by the Food and Drug Administration confirms again DiaSorin’s willingness to commercialize quality molecular diagnostic solutions in the field of respiratory diseases,” said Angelo Rago, President of Luminex. “The Simplexa ™ COVID-19 Direct test will provide reliable results for US medical personnel, enabling them to make quick and effective diagnostic decisions to combat SARS-CoV-2 infections.”