Roche launches new COVID-19 test for tracking emerging mutations

Roche cobas analyzer
Dubbed the Variant Set 1 test, Roche said it plans to provide additional sets as needed should more mutations arise. (Roche)

Roche launched a new COVID-19 test to help researchers monitor emerging variants and track mutations in the coronavirus’s genome that may make the disease more contagious or more deadly. 

The test is specifically designed to separate out COVID-19 infections caused by the three growing variants first discovered in the U.K., South Africa and Brazil late last year—designated B.1.1.7, B.1.351 and P.1, respectively.

It’s designed to be used in diagnostics laboratories to help establish how far the new mutations have spread as well as what impacts the changes in their genetic code may have on the effectiveness of other coronavirus tests, treatments and vaccines.

These new lineages can contain multiple mutations in the virus’s spike protein, changing the shape of what it uses to enter and infect human cells—and what also serves as a target for therapeutics that aim to stem the pandemic.

“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 Roche Diagnostics CEO Thomas Schinecker, Ph.D. “Continued surveillance is essential for public health.”

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Dubbed the Variant Set 1 test, the research use only assay is designed to run on the company’s high-throughput cobas 6800/8800 systems. Roche said it plans to provide additional tests as needed should more variants arise, and it has begun conducting regular assessments of the effectiveness of its own clinical diagnostics, finding they currently remain accurate in detecting active infections.

The B.1.1.7 variant—with eight mutations in the spike protein alone—has quickly become the dominant strain since it was reported last December. Two of those genetic changes have been linked with increased transmissibility, while studies have also shown overall increases in near-term death rates, according to the University of Minnesota’s Center for Infectious Disease Research and Policy, known as CIDRAP.

The B.1.351 mutation arose separately, but at the same time, with variations that may help it evade the body’s immune system. P.1, meanwhile, is a close relative of B.1.351.