As fast as COVID-19’s omicron variant is predicted to spread, diagnostics companies hope to be faster by quickly developing new tests to detect the coronavirus' newest mutations.
Roche—48 hours after completing its acquisition of its longtime infectious disease partner TIB Molbiol on Dec. 1—announced its latest division has developed three research-only kits that compare the changes in omicron’s genome to other SARS-CoV-2 variants and aim to help researchers better understand the virus’ behavior.
“There is still much to learn about Omicron,” Roche Diagnostics CEO Thomas Schinecker said in a statement Dec. 3. “It's critical to identify Omicron quickly and accurately, which will help inform ongoing research—including the further development of therapeutics and vaccines—and potentially stop or slow down the advance of this new variant.”
TIB Molbiol specializes in developing tests rapidly in the face of emerging diseases. Over the past two decades, the Berlin-based company and Roche have collaborated on earlier SARS outbreaks as well as on MERS, Ebola, Zika, anthrax, swine flu and bird flu.
During the earliest stages of the COVID-19 pandemic, in January 2020, TIB Molbiol and Roche became the first to provide a research-use-only detection test just days after the genome of the novel coronavirus was first sequenced.
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The company’s latest three VirSNiP variant kits analyze the genes that make up the virus’ spike protein—with omicron estimated to harbor about 30 different mutations compared to previous strains, according to the World Health Organization. The tests are designed to run on Roche’s LightCycler and cobas z 480 analyzers.
After the world received an early warning for omicron thanks to virus-sequencing efforts conducted in South Africa and Botswana, the diagnostics industry initially raced to see if the mutations would hinder the accuracy of their COVID-19 tests already on the market.
Test makers including Thermo Fisher Scientific, Abbott, Qiagen, Cue Health and more quickly reported that their clinical diagnostics would not be affected by omicron, as they largely rely on genes and proteins that have not been mutated to reach a positive result.
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On the vaccine front, Moderna, Pfizer, Johnson & Johnson and AstraZeneca have all announced they will test out an omicron-specific shot and that they are assessing the effectiveness of their current inoculations.
Meanwhile, Roche is also launching a rapid antigen test in Europe that screens for COVID-19 as well as influenza A and B. With instrument-free results expected in under 30 minutes, the company said it plans to begin rolling out the test before the end of the year to healthcare providers in countries accepting the CE Mark through a global distribution partnership with SD Biosensor.
“It is critical that healthcare professionals have the ability to quickly know whether a patient has an infection with either SARS-CoV-2 or the flu, especially as the COVID-19 pandemic extends into our flu season,” Schinecker said. “The combination rapid antigen test will help ensure the right decisions are taken by healthcare providers to treat patients and ultimately prevent community spread.”
Roche will also pair its test with its Navify Pass, a digital app that allows individuals and healthcare professionals to display and share their COVID-19 test results and vaccine status.