December 6, 2021 01:00 ET | Source: F. Hoffmann-La Roche Ltd F. Hoffmann-La Roche Ltd
Basel, December 6, 2021-Roche (six names: RO, ROG; OTCQX: RHHBY) today announced plans to launch SARS-CoV-2 and Flu A/B rapid antigen tests for professional use, from the very beginning The market that accepts the CE mark is January. Roche also intends to apply for an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) in early 2022.
The SARS-CoV-2 and influenza A/B rapid antigen test is designed to be used by healthcare professionals to quickly distinguish SARS-CoV-2 and influenza virus A and B infections in individuals with symptoms consistent with COVID-19 or influenza. A single comprehensive combination test uses a nasopharyngeal swab sample to produce a qualitative result ("yes/no" answer) for the presence of SARS-CoV-2 and/or influenza A and/or influenza B antigens within 15-30 minutes. The relative sensitivity of this test to SARS-CoV-2 is 84.85%, and the specificity is 98.59%. For influenza, the molecular test positive rate of the test is 81.16% (influenza A virus) and 100% (influenza B virus), and the relative specificity is 100% (influenza A virus) and 99.04% (influenza B virus). ) ).1 The currently available Omicron variant SARS-CoV-2 (B.1.1.529) sequence has been analyzed. According to the initial computer research, it is expected that it will not affect the test performance.
In environments where timely clinical decisions are required or central laboratory testing is difficult to obtain, it is beneficial to equip healthcare professionals with a single comprehensive combination of tests. SARS-CoV-2 and influenza A/B rapid antigen testing can help healthcare professionals quickly diagnose and distinguish infections from any of the three respiratory viruses at the point of care, and help take appropriate action plans, including patients and pandemics Management decision.
Thomas Schinecker, CEO of Roche Diagnostics, said: "It is vital that healthcare professionals can quickly understand whether patients are infected with SARS-CoV-2 or influenza, especially when the COVID-19 pandemic spreads to our Influenza season. Combined rapid antigen testing will help ensure that healthcare providers make the right decisions to treat patients and ultimately prevent community transmission. As we transition from today’s global health emergency to tomorrow’s epidemic phase, the test increases A solution that is critical to the long-term management of SARS-CoV-2 and seasonal influenza in the healthcare system."
Together with SARS-CoV-2 and Flu A/B rapid antigen test, Roche provides NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display and share their COVID-19 test results and vaccine status. By placing a unique personalized data matrix in the test, NAVIFY® Pass can automatically read all the detailed information about the test and establish a connection between the patient and his personal test results.
This release will cooperate with SD Biosensor Inc., Roche signed a global distribution agreement with the company, and before then launched the SARS-CoV-2 rapid antigen test (nasopharynx/nasal cavity), SARS-CoV-2 nasal cavity antigen auto The SARS-CoV-2 rapid antibody test will be carried out in 2020 and 2021 in countries/regions that accept the CE mark. The test will be the fifth rapid test and a 20-second supplement to Roche's comprehensive diagnostic solution portfolio to help the global healthcare system fight the COVID-19 pandemic through laboratory testing and point-of-care. Roche Diagnostics' product portfolio includes a wide range of molecular, serological, and digital solutions that can help diagnose and manage COVID-19 during the initial phase of infection, the recovery phase, and after the infection is resolved.
About SARS-CoV-2 and Flu A/B Rapid Antigen Detection SARS-CoV-2 and Flu A/B Rapid Antigen Detection is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of the nucleocapsid protein of SARS-CoV Antigen-2. Influenza A virus and Influenza B virus in human nasopharyngeal swab samples. The test is designed to help healthcare providers perform the differential diagnosis of SARS-CoV-2, influenza A, and influenza B infections on individuals with suspected respiratory virus infection consistent with COVID-19 or influenza within the first five years. sky.
The test has a relative specificity of 98.59% for SARS-CoV-2, 100% for influenza virus A, and 99.04% for influenza virus B. The relative sensitivity to SARS-CoV-2 is 84.85%. These performance characteristics are based on a prospective study of 104 participants, where each participant collected two nasopharyngeal swab samples and compared the results of the rapid antigen test with the results of the FDA-approved high-sensitivity RT-PCR method . Due to the limited transmission of influenza viruses last season, stored human nasopharyngeal swab samples were used to assess the susceptibility to influenza viruses A and B respectively. Comparing the results of rapid antigen detection with the results of high-sensitivity RT-PCR methods, the positive percentages of influenza A virus and influenza B virus were 81.16% and 100%, respectively. A prospective clinical study is underway to use fresh clinical samples to assess the manifestations of influenza. This test is not used for self-testing. It is intended for professional use in laboratories and test environments close to patients.
About antigen detection Antigen detection can detect proteins that are structural or functional components of a pathogen and are very specific to the pathogen. In this case, the test will provide a qualitative "yes/no" answer regarding the presence of the antigen in the patient sample, and can be provided as a rapid strip test, performed by a healthcare professional at the point of care. If the target antigen (nucleocapsid protein in this case) is present in a sufficient concentration in the sample, it will bind to the specific antibody and produce a visually detectable signal on the test strip, usually within 15 to 30 minutes. The result can be obtained. Rapid antigen testing can reliably detect individuals with high viral loads, allowing healthcare professionals to quickly identify those patients who are most at risk of spreading infection.
Regarding Roche's response to the COVID-19 pandemic, as a leading healthcare company, we are doing our best to support countries in the fight against COVID-19 and minimize its impact. We have developed more and more diagnostic solutions to help detect and diagnose infections and provide digital support for the healthcare system. We also continue to identify, develop and support therapies that can play a role in the treatment of diseases.
The impact of COVID-19 extends beyond the people infected with it. This is why we work with healthcare providers, laboratories, authorities, and organizations to help ensure that patients continue to receive the testing, treatment, and care they need during these challenging times. Based on a long-term tradition of cooperation, we are working with the government and other parties to make healthcare stronger and more sustainable in the future.
Reliable, high-quality testing is essential to help the healthcare system overcome this epidemic, and Roche has so far launched 21 diagnostic solutions to help minimize the impact of COVID-19. After sequencing the new SARS-CoV-2 virus in early 2020, we started work. On March 13, 2020, we became the first company to receive an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to perform a large number of molecular tests to detect viruses. Since then, we have continued to add a series of diagnostic solutions to our global product portfolio to help fight COVID-19. In addition to the gold standard PCR test, we have also developed an antigen test to help diagnose viruses in environments with limited molecular laboratory infrastructure, rapid antigen tests that can detect viruses on the spot, and detect influenza and COVID-19. High-throughput and points of care, as well as tests that can detect antibodies to the virus, can help monitor the spread of the virus and support the development of vaccines. In March 2021, the SARS-CoV-2 variant test was launched to detect critical spike mutations.
In addition to these tests, we have also studied how to support the care of COVID-19 patients, accepted the EUA of the US FDA for the Elecsys® IL-6 test to help identify severe inflammatory reactions in confirmed COVID-19 patients, and launched Roche v-TAC , This is a digital algorithm that can help simplify the screening, diagnosis, and monitoring of patients with COVID-19 respiratory damage. Roche is working closely with governments and health authorities around the world and has significantly increased production to support the availability of global testing.
Roche is also actively involved in understanding the potential of existing drug combinations and is studying future options. In 2020, Roche has established many new partnerships with Regeneron and Gilead to develop, manufacture and distribute molecules that can treat and prevent COVID-19.
Roche and Regeneron formed a partnership to jointly develop Ronapreve™ (casirivimab and imdevimab, known as REGEN-COV™ [USA] in the United States). The antibody combination has been approved for use in the European Union and Japan, and is conditionally used in the United Kingdom and Australia, and is authorized for emergency or temporary use in other regions such as the United States and Canada. In addition, the World Health Organization recommends the use of Ronapreve to treat COVID-19 patients.
In addition, we have also explored the potential of our existing drug Actemra/RoActemra in three global phase III clinical trials to study its safety and effectiveness in COVID-19-related pneumonia (COVACTA, EMPACTA, and REMDACTA). In June 2021, Actemra/RoActemra received an EUA from the US FDA for intravenous treatment of COVID-19, for receiving systemic corticosteroid therapy and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. In addition, the World Health Organization recommends Actemra/RoActemra to treat certain COVID-19 patients.
For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About SD Biosensor SD Biosensor is a global in vitro diagnostic company focusing on the development of POC immunoassays and molecular diagnostic products. SD Biosensor was established in 2010 and has been committed to research and development of products that can help patients diagnose quickly and accurately throughout the test process. Through these innovative products, they are striving to become the world's leading in vitro diagnostic company.
For more information, please visit www.sdbiosensor.com. About Roche Roche is a global pioneer in the field of pharmaceuticals and diagnostics, committed to promoting scientific progress to improve people's lives. The combined advantages of pharmaceuticals and diagnostics, as well as the growing capabilities in the field of data-driven medical insights, help Roche provide truly personalized healthcare. Roche is working with partners throughout the healthcare industry to provide the best care for everyone. Roche is the world's largest biotechnology company with truly differentiated drugs in the fields of oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also a world leader in in vitro diagnostics and tissue-based cancer diagnosis, and a leader in diabetes management. In recent years, the company has invested in genomic analysis and real-world data partnerships, and has become an industry-leading medical insight partner. Founded in 1896, Roche is constantly looking for better ways to prevent, diagnose and treat diseases, and make sustainable contributions to society. The company also aims to improve patients' access to medical innovation by working with all relevant stakeholders. More than 30 drugs developed by Roche are included in the World Health Organization's standard list of essential medicines, including life-saving antibiotics, antimalarials and anticancer drugs. In addition, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Index (DJSI) for the 13th consecutive year. The Roche Group is headquartered in Basel, Switzerland, and has operations in more than 100 countries. In 2020, it has more than 100,000 employees worldwide. In 2020, Roche invested 12.2 billion Swiss francs in research and development and sales of 58.3 billion Swiss francs. In the United States, Genentech is a wholly-owned member of the Roche Group. Roche is a major shareholder of Chugai in Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this press release are protected by law. References [1] SD biosensor. (2021). SARS-CoV-2 and influenza A/B rapid antigen detection package insert.
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