Updated: Jan 17, 2022
Acutis Diagnostics, a clinical diagnostics laboratory headquartered in New York, announced today that it has released a multiplex laboratory test for the detection of SARS-CoV-2, the causative agent of COVID-19. The assay will be available beginning Monday, March 23, 2020, and will be run under an Emergency Use Authorization granted to Acutis from the FDA. The assay will use a standard nasopharyngeal specimen from which Acutis will extract viral RNA and then test for the presence of key genes that can be used to identify its presence.
“We are very proud of our outstanding research and development team who have worked tirelessly on this validation,” commented Jibreel Sarij, CEO. “While offering an assay based on a EUA obtained by a diagnostic manufacturer rather than pursuing our own might have been simpler, our team felt that by using our skill set honed in the design of our other molecular assays, it would allow us to provide the most effective solution to our clients. This process, whereby we performed prescribed validation steps using various sample types, provided us with a deeper understanding of the assay than we might have experienced otherwise. We are thankful to our development partners who have worked diligently along with our scientists, not only in providing some of the key validation material but also in ensuring us that they will be able to keep up with the demand that we have been seeing nationwide.”
The Acutis SARS-CoV-2 test is a multiplex assay that targets three key genes—ORF1ab, N, and E, that scientists believe are key to accurately identifying the presence of the virus in patient samples. This assay is to be ordered under the guidelines issued by CDC and various departments of health to identify the presence of the virus in symptomatic patients who have tested negative for other respiratory viruses.