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Roche Announces Filing for FDA EUA for SARS-CoV-2 Rapid Antigen Test

Image created by Dr. Michael J. Miller

Roche announced today the submission for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a SARS-CoV-2 Rapid Antigen Test that is designed for use by healthcare professionals in point-of-care settings with patients experiencing symptoms of COVID-19. 

The test is designed to help healthcare professionals quickly identify a SARS-CoV-2 infection, typically in 15 minutes, in people exhibiting symptoms of the virus. It uses a simple nasal swab sample and comes in a small, convenient kit that does not require laboratory instruments, so it can be used at various point-of-care locations close to the patient and in settings where healthcare resources are limited. The test is highly beneficial where timely decisions are needed and PCR tests are not readily available. 

"As the COVID-19 pandemic persists, it's becoming more and more important to increase access to testing for all patients in multiple settings, particularly at the point of care," said Matt Sause, President & CEO of Roche Diagnostics North America. "This new rapid antigen test will provide a much needed resource to the healthcare system, as broad access to testing will be critical for re-opening our society."

To accompany the test launch, Roche will offer NAVIFY® Pass, a digital solution that includes mobile applications for healthcare providers and test recipients to share diagnostic results in real time with interested parties. The application is easy to configure and helps streamline healthcare provider digital operations. 

Roche expects to have tens of millions of SARS-CoV-2 Rapid Antigen Tests available per month in the United States at launch, with the capacity to produce additional volumes as needed to help address pandemic testing demand. The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and launched the SARS-CoV-2 Rapid Antigen Test and the SARS-CoV-2 Rapid Antibody Test in countries accepting the CE mark in 2020.

This test will be a valuable addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

About antigen testing

An antigen test detects proteins that are structural or functional components of a pathogen and are thus very specific to that pathogen.1 In this case, the test would provide a qualitative "yes/no" answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes.2

In general, antigen tests have a high specificity, though are not as sensitive as molecular tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analyzed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.

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