News

Roche receives FDA authorisation for sample pooling with the cobas SARS-CoV-2 Test on cobas 6800/8800 Systems

21.10.2020

  • Sample pooling can help conserve limited COVID-19 testing resources and make the process more efficient, allowing more people to be tested with fewer resources 

  • The cobas SARS-CoV-2 Test can now support testing of up to and including six individual samples at once in a single pool 

  • Sample pooling for cobas SARS-CoV-2 Test is the latest addition to a growing portfolio of Roche testing solutions to support healthcare systems and patients in the fight against COVID-19

 

Pleasanton, 21 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) authorisation for sample pooling with the cobas® SARS-CoV-2 Test on cobas® 6800/8800 Systems. The test was the first commercial novel coronavirus test to receive FDA Emergency Use Authorization (EUA) in March. Laboratories in the U.S. and other countries accepting the FDA EUA may now test as many as six individual samples at once in a single pool with the Roche test. 

 

“The pandemic has created extraordinary demand for SARS-CoV-2 testing, and Roche continues to work with health authorities to facilitate safe and effective approaches to combat the COVID-19 public health crisis,”

said Mario Torres, Head of Roche Molecular Diagnostics.

 

“By offering a sample pooling workflow, we enable customers to implement appropriate pooling strategies to test more people using fewer resources where it makes sense. With this new workflow, our aim is to continue providing as many tests as possible to better serve patients and their healthcare communities.” 

 

Samples included in pools with a positive or presumptive positive result will need to be tested individually prior to reporting a result. Roche plans to launch the pooling protocol in markets accepting the CE mark in the future, and continues to partner with healthcare providers, laboratories, authorities and organisations to provide reliable, high-quality molecular testing solutions in the fight against COVID-19.

 

About Emergency Use Authorization status

 

The cobas SARS-CoV-2 Test has not been FDA cleared or approved. It has been authorised by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high-complexity tests. Testing of pooled samples is limited to U.S. laboratories certified under CLIA, 42 U.S.C. §263a, that meet requirements to perform high complexity tests only. The test has been authorised only for the detection of RNA from SARS-CoV-2 virus, not for any other viruses or pathogens. It is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorisation is terminated or revoked sooner.

 

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 a new strain which has not previously been identified in humans.1

 

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

 

About cobas SARS-CoV-2 Test 

 

cobas SARS-CoV-2 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 clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. cobas SARS-CoV-2 is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests. 

 

This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples from clinician-instructed self-collected nasal swab specimens (collected on site), or clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens. Negative results from pooled samples should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually. Specimens included in pools with a positive or presumptive positive result must be tested individually prior to reporting a result. Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing. Testing of pooled samples is limited to laboratories certified under CLIA, 42 U.S.C. §263a, that meet requirements to perform high complexity tests. 

 

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; 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, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. cobas SARS-CoV-2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas 6800/8800 Systems. cobas SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

 

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 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 Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh 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 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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] https://www.who.int/health-topics/coronavirus. Accessed 18Sep2020.

 

Media Relations

 

Elizabeth Baxter

Elizabeth.Baxter@Roche.com

925.523.8812

 

Mike Weist

mike.weist@roche.com

317.371.0035