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Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations

Christian Fernsby |
Roche announced the launch of 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).

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This 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.

Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each carrying a number of genomic mutations. Among them, mutations E484K, N501Y and del 69-70 are located in the spike protein, the region that enables the virus to attach to and enter the human cell. Studies have suggested that these mutations may be linked to increased disease transmissibility, and possibly decreased therapeutic and vaccine efficacy.1-4

“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.”

The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, high-volume cobas 6800/8800 Systems. Pre-optimised assay design, ready-to-use test cassettes and predefined software parameters enable laboratories to reduce testing complexity and increase walkaway time.

It is important to note that 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.

About SARS-CoV-2 Variants B.1.1.7, B.1.351 and P.1

First reported in the UK in December 2020, B.1.1.7 variant has quickly become the dominant circulating variant and has since been found in countries worldwide.1 B.1.1.7 carries a large number of mutations, eight of which are accumulated in the spike region. Preliminary studies have suggested that two such spike mutations, N501Y and del 69-70, are associated with increased transmissibility of the disease.2,3

Another variant, B.1.351, which arose independently from B.1.1.7, was reported in South Africa in December 2020. In addition to having mutation N501Y, B.1.351 carries another spike mutation E484K, which appears to evade the body’s immune response, possibly diminishing vaccine efficacy.

Variant P.1, a close relative to B.1.351, has several defining mutations including N501Y and E484K in the spike region. P.1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants.5

About cobas SARS-CoV-2 Variant Set 1 Test

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. Roche is committed to providing additional variant tests as needed based on regular assessments of the infectious disease landscape.

About cobas 6800/8800 Systems

When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.

With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success now, more than ever.

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