● Immunocompromised transplant recipients are at risk of major complications when infected with adenovirus, a common and highly contagious virus
● Healthcare professionals can use this new test to determine whether transplant patients are at risk of developing severe illness from adenovirus infection
● The Adenovirus Test leverages the flexibility, automation, and reliability of the cobas omni Utility Channel on the cobas 6800/8800 Systems, improving workflow efficiencies compared to laboratory developed tests
Pleasanton, 15 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the commercial availability of a quantitative Adenovirus (ADV) Test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems in countries accepting the CE mark. The new Adenovirus Test will help healthcare professionals better monitor and manage severely immunocompromised transplant patients at risk of infections.
“Transplant patients face the risk of significant complications due to adenovirus and other infections,” said Mario Torres, Head of Roche Molecular Diagnostics. “This new addition to our menu provides a more comprehensive solution for laboratories to offer improved monitoring tools so that treatment plans can be adjusted as necessary, providing better patient care.”
Roche’s comprehensive transplant menu now allows critical transplant testing (Cytomegalovirus, Epstein-Barr virus, BK virus and human Adenovirus) on the consolidated cobas 6800/8800 Systems along with other infectious disease tests. The 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, providing laboratories with improved operating efficiency and the flexibility to adapt to increasing testing demands.
About the quantitative Adenovirus Real Time PCR Test
The Adenovirus Test is based on real-time PCR (polymerase chain reaction) and provides quantitative accuracy for detection and quantification of human adenovirus. The test is designed to work in conjunction with the cobas omni Utility Channel reagent to simplify workflow. The assay calibrators are traceable to the World Health Organization (WHO) international standard for adenovirus and reports in International Units Per Millilitre (IU/mL). The test minimizes variability and complexity in testing, offering an alternative to lab-developed tests (LDTs), and reduces workload and alleviates risk for laboratories.
About adenovirus
Adenovirus is a member of the adenoviridae virus family and has been associated with a range of clinical diseases. Adenovirus spreads most commonly through a cough or a sneeze, direct conjunctival inoculation, fecal-oral spread, or exposure to infected tissue or blood1.
Once infection with human adenovirus occurs, the virus establishes as a latent form and can remain in the body. Most people harbor the virus with no long-term clinical ramifications; however, immunocompromised patients are more likely to develop conjunctivitis, gastroenteritis, hepatitis, myocarditis and pneumonia, all of which can cause complications and organ rejection2.
About the cobas omni Utility Channel on the cobas 6800/8800 Systems
The cobas omni Utility Channel on the cobas 6800/8800 Systems enables a broader testing menu by consolidating open channel assays with Roche in vitro diagnostics (IVD) assays on a single platform. Open channel assays may include IVD assays, as well as routine lab developed tests (LDTs). The ability to consolidate and automate a wider array of testing on a single platform helps to increase operational efficiency, maximise laboratory space and minimise capital investment.
Since 2014, the cobas 6800/8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their IVD and LDT testing to a single system while increasing overall workflow efficiencies.
The systems provide up to 96 results in about three hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of work-away time with minimal user interaction.
For more information about the tests and system, please visit www.diagnostics.roche.com or http://molecular.roche.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 Organization 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 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 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.
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References
- Ison. Adenovirus Infections in Transplant Recipients. Emerging Infections. Clinical Infectious Diseases (2006) 43:331-9
- Ghebremedhin. Human Adenovirus: Viral Pathogen with Increasing Importance. European Journal of Microbiology and Immunology 4 (2014) 1, pp. 26–33