• Broad and trusted portfolio of COVID-19 rapid tests feature innovative updates and enhanced performance, building on insights gained throughout the pandemic
  • All tests now work seamlessly with navify® Pass, Roche’s digital solution that allows individuals and healthcare professionals to immediately store, display, and share COVID-19 vaccination status and test results through a unique data matrix
  • Roche maintains the capacity to provide tens of millions tests each month to meet sustained high worldwide demand from individuals and healthcare professionals

Basel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its next-generation portfolio SARS-CoV-2 rapid antigen tests (“2.0”) for self-testing and professional use in countries accepting the CE Mark. Distribution of the new rapid test portfolio is projected to begin in the coming weeks.

In doing so, Roche builds upon one of the broadest portfolios of COVID-19 rapid testing solutions with three new test configurations that feature enhanced performance through the use of an improved capture antibody and the addition of new digital data sharing capabilities to all tests. Using nasopharyngeal and nasal swab samples, respectively, the tests deliver reliable results in as few as 15 minutes, aiding in the diagnosis of SARS-CoV-2 infection in individuals with or without symptoms consistent with COVID-19.

“The continued evolution of the SARS-CoV-2 virus and COVID-19 pandemic reinforce the need for individuals and healthcare systems to have access to the most reliable rapid testing solutions possible,” said Thomas Schinecker, CEO, Roche Diagnostics. “As a leader in diagnostic innovation, we are proud to be one of the first among our industry to apply insights gained from the past two years toward a next-generation rapid test portfolio. These tests are ready to support global society as we navigate this next phase of the pandemic.”

The three tests set to launch are the following:

Professional use:

  • SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling)
  • SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling)

Self-Test:

  • SARS-CoV-2 Antigen Self Test Nasal (nasal sampling)

Roche maintains the capacity to provide several tens of millions of each of the tests per month, with the option to quickly build up additional capacity if needed, to address sustained high worldwide demand for rapid testing from governments, healthcare systems and individuals. The next-generation test portfolio will be introduced in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched a range of rapid antigen and antibody tests in more than 50 countries worldwide.

The tests join Roche Diagnostics’s broader COVID-19 portfolio, which includes a wide range of molecular, serological and digital solutions that help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, and following the resolution of infection.

About the next-generation portfolio of SARS-CoV-2 rapid antigen tests (“2.0”)
Lab testing showed that all three tests can qualitatively detect major variants of concern including Delta and Omicron variants. Emerging variants are continuously monitored.

SARS-CoV-2 Rapid Antigen Test 2.01 (nasopharyngeal sampling)
The SARS-CoV-2 Rapid Antigen Test 2.0 is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasopharyngeal swab samples. In a prospective clinical studyA , the SARS-CoV-2 Rapid Antigen 2.0 showed a relative sensitivity of 99.00% (95% CI: 94.55 – 99.97%) and a relative specificity of 99.75% (95% CI: 98.62 – 99.99%). In total, 100 PCR-positive and 402 PCR-negative subjects participated in this study. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 182 symptomatic individuals, among whom 66 were positive and 116 were negative. This test is intended as an aid in the diagnosis of SARS‑CoV‑2 infection in individuals with or without symptoms consistent with COVID‑19. This product is intended for professional use in laboratory and near‑patient testing environments. This product is not intended for self‑testing.

SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2 (nasal sampling)
The SARS-CoV-2 Rapid Antigen Test 2.0 Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal swab samples. In prospective clinical studiesA,B, the SARS-CoV-2 Rapid Antigen 2.0 Nasal showed a relative sensitivity of 95.80% (95% CI: 91.09 – 98.44%) and a relative specificity of 100% (95% CI: 99.25 – 100%). In total, 143 PCR-positive and 487 PCR-negative subjects participated in these studies. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 310 symptomatic individuals, among whom 109 were positive and 201 were negative. This test is intended as an aid in the diagnosis of SARS‑CoV‑2 infection in individuals with or without symptoms consistent with COVID‑19. This product is intended for professional use in laboratory and near‑patient testing environments. This product is not intended for self‑testing.

SARS-CoV-2 Antigen Self Test Nasal3
The enhanced SARS-CoV-2 Antigen Self Test Nasal is a so-called lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal samples. This test is used to detect antigens of the SARS-CoV-2 virus in individuals suspected of having COVID-19. It is designed as a self-test for patients. In prospective clinical studiesA, B, the SARS-CoV-2 Antigen Self Test Nasal showed a relative sensitivity of 95.8% (95% CI: 91.09 – 98.44%) and a relative specificity of 100% (95% CI: 99.25 – 100%). In total, 143 PCR-positive and 487 PCR-negative subjects participated in these studies. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 310 symptomatic individuals, among whom 109 were positive and 201 were negative. 128 of the subjects were lay-users, sampling and testing themselves or another lay-user, for example their underaged childrenB.