Roche receives CE mark for the use of saliva samples with cobas SARS-CoV-2 Qualitative test on cobas 6800/8800 Systems

PLEASANTON, Calif., Dec. 17, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its cobas® SARS-CoV-2 Qualitative test has received CE mark for the use of saliva samples in the detection of SARS-CoV-2 on the widely available, high-throughput cobas® 6800/8800 Systems. This non-invasive test is for any individual, including those suspected of COVID-19 and those without symptoms. Saliva sample collection represents a convenient testing approach for patients, who can easily self-collect their own samples.

"One of the key strategies to reduce COVID-19 transmission is to stop the silent spread of the disease early," said Cindy Perettie, Head of Molecular Labs, Roche Diagnostics Solutions. "Expanding sensitive testing to include a non-invasive, easy-to-collect sample type such as saliva helps to improve access to screening for more people. This is crucial for public health and keeping our communities safe."

Due to the non-invasive nature of the test, it is a more tolerable experience for people who require frequent testing, such as those working in a high-risk environment. The test also provides patients with the option to self-collect their saliva sample on site, following the instructions of a healthcare professional. By reducing physical contact, this method of sample collection can help decrease the risk of exposure to the virus for healthcare professionals.

With the addition of saliva to the already available sample types of nasal, nasopharyngeal, and oropharyngeal swabs, Roche provides a broad range of testing options that deliver accurate detection of SARS-CoV-2, even in the presence of the Omicron variant, and can help patients and healthcare providers better manage the ongoing COVID-19 pandemic.

About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is recently identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever.² In more serious cases, severe acute respiratory syndrome and death can occur.

About the cobas SARS-CoV-2 Qualitative test
The cobas SARS-CoV-2 Qualitative test for use on the cobas 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in healthcare provider-instructed self-collected anterior nasal swab and saliva specimens (collected on site), and healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens collected from any individuals, including those suspected of COVID-19 by their healthcare provider, and those without symptoms or other reasons to suspect COVID-19.

Results are for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA but may not represent the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The cobas SARS-CoV-2 Qualitative test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab's long-term sustainability and success, now, more than ever. Learn more now: www.cobas68008800.com.

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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

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. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] European Centre for Disease Prevention and Control. Considerations for the use of saliva as sample material for COVID-19 testing. https://www.ecdc.europa.eu/en/publications-data/considerations-use-saliva-sample-material-covid-19-testing.
[2] Johansson MA, Quandelacy TM, Kada S, et al. SARS-CoV-2 Transmission From People Without COVID-19 Symptoms. JAMA Netw Open. 2021;4(1):e2035057. Published 2021 Jan 4. doi:10.1001/jamanetworkopen.2020.35057.

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SOURCE Roche