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The qualitative cobas SARS-CoV-2 is one of the first COVID-19 PCRs performed on a high-throughput automated platform to obtain FDA 510(k) clearance.
This FDA authorization will ensure that the healthcare network has fast, reliable, and accurate COVID-19 PCR tests beyond the U. S. period.
Based on uninterrupted analyses carried out since the beginning of the pandemic, all Roche molecular tests, adding the SARS-CoV-2 Qualitative cobas test, encounter all SARS-CoV-2 variants.
Basel, October 24, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U. S. Food and Drug Administration (FDA) is being able to participate in the U. S. Food and Drug Administration (FDA). The U. S. Department of Agriculture has granted 510(k) authorization for the SARS-CoV-2 cobas qualitative PCR test for use in the cobas 6800 and cobas®®® 8800 fully automated systems. This independent verification is designed for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from suspected symptomatic patients. of having COVID-19, as decided through your physical care provider.
The SARS-CoV-2 cobas qualitative test has been available in the United States under the Emergency Use Authorization (EUA) since March 2020 and is the first advertising molecular test to obtain this status. FDA approval is based on a complete dossier submitted to the agency, adding analytical and clinical studies.
“We are pleased to have reached this regulatory milestone. Roche is fully committed to continuing its innovation for COVID-19 diagnostics to meet changing fitnesscare desires and help keep communities safe,” said Thomas Schinecker, CEO of Roche Diagnostics. working with the fitness government to offload FDA approval prestige for testing into our COVID-19 portfolio. This will give certain physicians and patients continued access to accurate, reliable and effective testing options. “
With the continued evolution of coronavirus variants and surge surges around the world, Roche will continue to upload diagnostic responses to the global portfolio to combat COVID-19. COVID-19, stop by on our COVID-19 reaction page.
About the qualitative verification of cobas SARS-CoV-2 The qualitative verification of cobas SARS-CoV-2 is a single-well double-target verification, which includes rapid detection of SARS-CoV-2 and detection of pan-sarbecovirus for the sarbecovirus subgenus including SARS-CoV-2. The test is a real-time RT-PCR test for the qualitative detection of SARS-CoV-2 nucleic acids in nasal and nasopharyngeal swab samples taken from symptomatic Americans suspected of COVID-19 through their healthcare provider. The check is run on cobas 6800/8800 systems and consists of a full negative check, a positive check and an internal check.
Negative effects do not exclude SARS-CoV-2 infection and should not be used as the sole basis for patient control decisions. The effects are intended to be used in conjunction with clinical observations, patient history, recent exposures, and epidemiological and laboratory data, in accordance with rules provided through the relevant public suitability authorities.
The cobas SARS-CoV-2 qualitative test is designed for use through a corps of qualified clinical laboratory workers, in particular informed and trained in real-time PCR techniques and the use of cobas®® 6800/8800 systems.
About cobas 6800/8800 systems Roche’s cobas 6800/8800 systems, used to perform the cobas SARS-CoV-2 test, deliver effects in 3 1/2 hours and offer greater operational efficiency, flexibility and faster reaction time. Results with the highest performance delivering up to 96 effects in approximately 3 hours and a total of 1440 effects for the COBAS 6800 system and 4128 effects for the COBAS 8800 system in 24 hours. The test can be run with other tests supplied through Roche for use on cobas 6800/8800 systems.
For more information about testing and the system, visit www. diagnostics. roche. com. About Roche Founded in 1896 in Basel, Switzerland, as one of the first brand-name drug brands, Roche has grown to become the world’s largest biotechnology. Company and world leader in in vitro diagnostics. The company strives for clinical excellence to detect and expand medicines and diagnostics and save the lives of others around the world. We are pioneers in personalized healthcare and need to further reshape the way healthcare is delivered. delivered to have an even greater impact. To provide the most productive care for each person, we partner with many stakeholders and combine our strengths in diagnostics and pharmacy with clinical practice knowledge.
In popularity of our efforts to take a long-term attitude in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry through the Dow Jones Sustainability Indices for the 13th consecutive year. This difference also reflects our efforts for access to health with local partners in all the countries where we work.
Genentech, in the United States, is a full member of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.
For more information, www. roche. com.
All trademarks used or referenced in this release are by law. References [1] World Health Organization [Internet; cited January 2020]. Available in https://www. who. int/health-topics/coronavirus.
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