Tucker, GA— April 17, 2021 —Quorum X Diagnostics, Inc. (QXD) has announced that it is awaiting Emergency Use Authorization (EUA) approval by the U.S. FDA for the first, 4-minute at-home COVID antigen test named COVIDNOW®. This test is available without prescription.
“We have every confidence that our EUA will be approved,” said CEO and Co-founder, Dr. Maria M. Nagy, “we have communicated with the FDA throughout the submission process and have submitted an extensive and solid evaluation of our product for efficacy and safety,” she continued.
COVIDNOW® has an Accuracy of 98.8%, Sensitivity of 96%, and Specificity of 100%. These data results were based on a sample size of over 350 patients. In addition, this technology was validated by two independent laboratories. These results were used as part of the clinical data required by the FDA for the EUA application.
Quorum X Diagnostics’ COVIDNOW®, at-home COVID-19 antigen test uses a lateral flow test cassette, proprietary technology (patent-pending) that is able to identify the presence of SARS-CoV-2 antigens in symptomatic and asymptomatic individuals in only 4-minutes. The test has also been shown to detect the US, UK, and South African SARS-CoV-2 variants.
“It’s “kinda” like a pregnancy test, but for Covid,” explained Dr. Nagy, “it’s safe, simple, and accurate.”
Upon EUA approval, COVIDNOW® will be available over-the-counter and comes complete with a sterile nasal swab, test tube with pre-filled reagent, and test cassette. The nasal swab only requires a one-inch anterior sample and not a full, nasopharyngeal swab typically done by healthcare providers for PCR testing.
“We believe that being able to identify an active infection in individuals (especially those that are asymptomatic) is crucial in helping control the spread of the SARS-CoV-2 virus. It’s not a solution for COVID but it’s definitely a tool that can help during this transitional period,” she continued.
The test cassette is optimized to be read by the AI technology embedded in the COVIDNOW® phone app. This app also provides step-by-step, video guided instructions, and official certificate of results that can be shared with employers, sports venues or for traveling. Additionally, this app can also assist, with contact tracing as well as deidentified, HIPPA compliant reporting of positive and negative cases to local, state and national agencies as recommended by the CDC.
Lastly, this app also has connectivity to optional instant telemedicine consultation at the click of a button. The COVIDNOW® test kit will be available in drugstores nationwide within weeks of approval
QXD has initiated a waitlist that can be found at www.covidnow.com.