Roche launches SARS-CoV-2 variant test

 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced

the launch of the cobas(R) SARS-CoV-2 Variant Set 1 Test to detect and 
differentiate mutations found in variants that originated in the UK 
(B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use 
only laboratory test can be used to help scientists track mutation 
prevalence and to assess any potential impact on diagnostics, vaccines 
and therapeutics, providing crucial insight for healthcare systems in 
making appropriate measures to combat COVID-19. 
 
 
 
   Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 
2020, with each carrying a number of genomic mutations. Among them, 
mutations E484K, N501Y and del 69-70 are located in the spike protein, 
the region that enables the virus to attach to and enter the human cell. 
Studies have suggested that these mutations may be linked to increased 
disease transmissibility, and possibly decreased therapeutic and vaccine 
efficacy.(1-4) 
 
 
 
   "Viruses naturally evolve over time. While most mutations do not have a 
clinical impact, some variants need to be tracked carefully as they seem 
to spread more easily and quickly," said Thomas Schinecker, CEO Roche 
Diagnostics. "Continued surveillance is essential for public health. Our 
latest solution provides laboratories a fast and efficient way to 
investigate these variants found in infected individuals and the 
potential impact on existing therapies, vaccines and tests." 
 
 
 
   The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, 
high-volume cobas(R) 6800/8800 Systems. Pre-optimised assay design, 
ready-to-use test cassettes and predefined software parameters enable 
laboratories to reduce testing complexity and increase walkaway time. 
 
 
 
   It is important to note that Roche has confirmed its existing diagnostic 
tests to detect SARS-CoV-2 are not affected by known mutations and 
remain accurate and effective in detecting active infections. The 
company is conducting assessments on a regular basis and will continue 
to monitor as new variants arise. 
 
 
 
   About SARS-CoV-2 Variants B.1.1.7, B.1.351 and P.1 
 
   First reported in the UK in December 2020, B.1.1.7 variant has quickly 
become the dominant circulating variant and has since been found in 
countries worldwide.(1) B.1.1.7 carries a large number of mutations, 
eight of which are accumulated in the spike region. Preliminary studies 
have suggested that two such spike mutations, N501Y and del 69-70, are 
associated with increased transmissibility of the disease.(2,3) Another 
variant, B.1.351, which arose independently from B.1.1.7, was reported 
in South Africa in December 2020. In addition to having mutation N501Y, 
B.1.351 carries another spike mutation E484K, which appears to evade the 
body's immune response, possibly diminishing vaccine efficacy.(4) 
Variant P.1, a close relative to B.1.351, has several defining mutations 
including N501Y and E484K in the spike region. P.1 has been circulating 
in the Amazon region as of late 2020 and is thought to evade immunity 
generated after infection by other variants.(5) 
 
 
 
   About cobas SARS-CoV-2 Variant Set 1 Test 
 
   cobas SARS-CoV-2 Variant Set 1 Nucleic Acid test for use with the cobas 
6800/8800 Systems is an automated, multiplex, real-time reverse 
transcription polymerase chain reaction (RT-PCR) assay for the rapid in 
vitro qualitative detection and discrimination of select SARS-CoV-2 
mutations E484K, N501Y and del 69-70. The test contains the respective 
primers and probes provided in the ready-made 384-test cassette. 
Automated data management is performed by the cobas 6800/8800 software, 
which assigns test results for all tests. Results can be reviewed 
directly on the system screen, and printed as a report. Roche is 
committed to providing additional variant tests as needed based on 
regular assessments of the infectious disease landscape. 
 
 
 
   About 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's response to the COVID-19 pandemic 
 
   As a leading healthcare company we are doing all we can to support 
countries in minimising the impact of COVID-19. We have developed a 
growing number of diagnostic solutions that help to detect and diagnose 
the infection in patients, as well as providing digital support to 
healthcare systems, and we continue to identify, develop and support 
potential therapies which can play a role in treating the disease. 
 
 
 
   We understand the impact of COVID-19 goes beyond those who contract it, 
which is why we are working with healthcare providers, laboratories, 
authorities and organisations to help make sure that patients continue 
to receive the tests, treatment and care they need during these 
challenging times. As we learn from the pandemic, we are partnering with 
governments and others to make healthcare stronger and more sustainable 
in the future. 
 
 
 
   Our diagnostics solutions: 
 
   Reliable, high-quality testing is essential to help healthcare systems 
overcome this pandemic. Our portfolio includes: 
 
 
   -- a high-volume molecular test to detect SARS-CoV-2, the virus that causes 
      COVID-19, (FDA Emergency Use Authorisation (EUA) and available in 
      countries accepting the CE Mark) 
 
   -- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the 
      presence of antibodies in the blood targeting the nucleocapsid (FDA EUA 
      and CE Mark) 
 
   -- an IL-6 test to assist in identifying severe inflammatory response in 
      patients with confirmed COVID-19 (FDA EUA and CE Mark) 
 
   -- Roche v-TAC, which could help simplify the screening, diagnosis and 
      monitoring of patients with respiratory compromise in the current 
      COVID-19 pandemic 
 
   -- a SARS-CoV-2 rapid antibody test to help determine at the point of care 
      whether a person has been exposed to the virus (CE Mark) 
 
   -- a rapid antigen test to support in the detection of SARS-CoV-2 at the 
      point of care within 15 minutes (CE Mark) 
 
   -- a high-volume molecular test to simultaneously detect and differentiate 
      between SARS-CoV-2 and influenza A/B, as the symptoms are similar for 
      both (FDA EUA and CE Mark) 
 
   -- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein 
      to support vaccination development and complement our existing portfolio 
 
   -- a point-of-care molecular PCR test that simultaneously detects and 
      differentiates between SARS-CoV-2 and influenza A/B infections to support 
      urgent triage and diagnosis (FDA EUA and CE Mark) 
 
   Our research into therapies 
 
 
 
   Roche is committed to improving the treatment of COVID-19. We are 
actively involved in understanding the potential of our existing 
portfolio and are exploring the potential of our investigational 
molecules. 
 
   In August we signed a collaboration agreement with Regeneron on 
developing and manufacturing and significantly increasing global supply 
of an investigational antibody combination for COVID-19 if it proves 
safe and effective in clinical trials and regulatory approvals are 
granted. We are also partnering with Atea to jointly develop AT-527, an 
orally administered direct-acting antiviral (DAA) currently in Phase 2 
clinical trials. If approved, Atea will distribute AT-527 in the United 
States and Roche will be responsible for global manufacturing and 
distribution outside the United States. 
 
   At the beginning of the pandemic, on 19 March, we announced the 
initiation of COVACTA - a global Phase III randomised, double-blind, 
placebo-controlled clinical trial to evaluate the safety and efficacy of 
intravenous Actemra(c)/RoActemra(c) (tocilizumab) plus standard of care 
in hospitalised adult patients with severe COVID-19 pneumonia compared 
to placebo plus standard of care. On 29 July we announced that COVACTA 
did not meet its primary endpoint of improved clinical status in 
patients with COVID-19 associated pneumonia or the key secondary 
endpoint of reduced mortality. 
 
   Separately, we have studied Actemra(c)/RoActemra(c) in the EMPACTA study 
in COVID-19 associated hospitalised pneumonia in patients that are often 
underrepresented in clinical trials. On 18 September we announced that 
the phase III EMPACTA study showed Actemra/RoActemra plus standard of 
care reduced the likelihood of progression to mechanical ventilation or 
death in hospitalised patients with COVID-19 associated pneumonia 
compared to placebo plus standard of care. However, there was no 
statistical difference in mortality between patients who received 
Actemra/RoActemra or placebo. 

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