The at-home test uses a nasal swab sample to accurately detect all known variants of concern, including Omicron, and delivers results within 20 minutes
Roche Diagnostics Design Center, Mannheim. (Credit: F. Hoffmann-La Roche Ltd.)
Swiss healthcare firm Roche has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its Covid-19 at-home test.
The rapid chromatographic immunoassay is indicated for self-collection and self-testing by individuals aged 14 years and above, and by an adult for children aged 2-13 years old.
It uses an anterior nasal swab sample to detect SARS-CoV-2 and all known variants of concern, including Omicron, and delivers accurate and rapid results within 20 minutes.
Roche has teamed up with South Korean in-vitro diagnostics company SD Biosensor for the launch of the Covid-19 at-home test.
The US FDA prioritised the authorisation of Covid-19 at-home test based on the partnership’s capability to deliver large volume of tests and speed up manufacturing.
The company aims to roll out the Covid-19 at-home test in the US, starting from January 2022.
Roche Diagnostics CEO Thomas Schinecker said: “The Covid-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities.
“At this inflection point in the American public’s fight against Covid-19, we are proud to have worked in close collaboration with the US Government to introduce and expand access to accurate, reliable and high-quality at-home tests.”
In clinical trial that enrolled 138 symptomatic individuals, the Covid-19 at-home test showed 95.3% relative sensitivity and 100% relative specificity.
Together with the test, the company would offer NAVIFY Pass to organisations who require individuals and health care professionals to store, display, and share the test results.
A unique data matrix will be provided, which enables NAVIFY Pass to automatically link the users’ test results to their corresponding test devices.
Roche claimed that Covid-19 at-home test is its first SARS-CoV-2 rapid antigen test to receive FDA EUA, and the sixth rapid test in its portfolio of Covid-19 diagnostic solutions.
Roche Diagnostics North America president and CEO Matt Sause said: “Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response.
“As long as there remains a need for reliable testing, Roche will continue to invest in effective solutions to ensure there are testing options available to those who need them.”