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Roche launches COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant - Jan 26 2023



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.


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.

About hepatocellular carcinoma

Liver cancer is the third leading cause of cancer death and one of the few cancers where mortality is rising.3,4 More than 900,000 people are diagnosed with the disease globally each year, which translates to one person diagnosed every 90 seconds.3 Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.

If diagnosed in the early stage, surgery may be prescribed to remove the primary tumour, however an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.1 Early recurrence is associated with poorer prognosis and shorter survival.1,2 Tumour size, number of tumours, and portal vein invasion are associated with an increased risk of recurrence.

About Tecentriq

Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and HCC. Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan

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