Roche launches COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant
- This new test for researchers specifically targets the XBB.1.5 Omicron sub-variant and runs on the real-time PCR platforms LightCycler® 480 II* and cobas® z480.
- Results from the test will help closely track the virus’ lineage and provide insights into the epidemiology and impact it has on public health.
- Concern from the World Health Organisation centres around the XBB.1.5 high transmissibility and growth advantage.1
Basel, 26 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5. The XBB.1.5 variant is prevalent in the United States and is quickly spreading to other countries. Being able to differentiate emerging variants and understand their similarities and mutations provides a basis for experts to make predictions about their spread and respond with appropriate treatment strategies. The test, VirSNiP SARS-CoV-2 Spike F486P, is for use on the LightCycler® 480 II and cobas® z 480.
“Roche continues to develop timely diagnostic innovations related to COVID-19 by providing valuable insights - helping scientists and physicians understand this new strain, how it differs from other variants, and the impact it may have on public health,” said Matt Sause, CEO of Roche Diagnostics. “Since the start of this global health crisis, Roche has been committed to bringing effective diagnostic solutions to address unmet needs to healthcare communities worldwide.”
XBB.1.5 is a sub-variant of a SARS-CoV-2 variant named XBB. That lineage is a recombinant of two descendants of the BA.2 lineage that began spiking in early 2022. BA.2 is also a sub-variant of Omicron. XBB’s spike protein is a group of mutations that boost the variant’s ability to evade antibodies.2 All Roche on-market COVID-19 tests are not impacted by this sub-variant.
The research-use-only test, VirSNiP SARS-CoV-2 Spike F486P, adds to the broad suite of COVID-19 test kits developed by Roche and TIB Molbiol. Roche and TIB Molbiol’s researchers continue to work in collaboration with partners globally to screen for new variants and emerging diseases.
About the VirSNiP SARS-CoV-2 Spike F486P
The VirSNiP SARS-CoV-2 Spike F486P test is for research use only and it specifically targets the unique mutation F486P found within the XBB.1.5 Omicron sub-variant. Typical clinical samples are throat and nasopharyngeal swabs, sputum, saliva or gargle solution.
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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*The LightCycler® 480 II is for research use only, not for diagnostic procedures.
 World Health Organisation, Director-General's opening remarks at information session for Member States – 5 January, 2023, Available from: https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-information-session-for-member-states
 Callaway, E. (2023) Coronavirus variant XBB.1.5 rises in the United States - is it a global threat?, Nature News. Nature Publishing Group. Available at: https://www.nature.com/articles/d41586-023-00014-3 (Accessed: January 10, 2023).
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