Roche Launches New SARS-CoV-2 Variant Test to Monitor Emerging Coronavirus Mutations

Roche (Basel, Switzerland) has launched the cobas SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1).

The cobas SARS-CoV-2 Variant Set 1 Nucleic Acid test for use with the cobas 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of select SARS-CoV-2 mutations E484K, N501Y and del 69-70. The test contains the respective primers and probes provided in the ready-made 384-test cassette. Automated data management is performed by the cobas 6800/8800 software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report.


The research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19. Roche has confirmed its existing diagnostic tests to detect SARS-CoV-2 are not affected by known mutations and remain accurate and effective in detecting active infections. The company is conducting assessments on a regular basis and will continue to monitor as new variants arise.

“Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” said Thomas Schinecker, CEO Roche Diagnostics. “Continued surveillance is essential for public health. Our latest solution provides laboratories a fast and efficient way to investigate these variants found in infected individuals and the potential impact on existing therapies, vaccines and tests.”