Press Release : Roche launches Elecsys Epstein-Barr Virus (EBV) immunoassay panel to improve EBV infection staging

 
   -- The Elecsys EBV panel accurately identifies the EBV infection stage from 
      a single blood sample, which means less confirmatory testing and, 
      potentially, faster diagnosis for patients 
 
   -- Clear and quick diagnosis of acute infection allows physicians to decide 
      faster on treatment for transplant patients 
 
   -- The EBV panel can be used to rule out other acute infections, such as 
      missed HIV infections 
 
 
   Basel, 31 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced that the Elecsys(R) EBV panel has launched in countries 
accepting the CE Mark. Roche will file for approval with the FDA in the 
future. The Elecsys(R) EBV panel consists of three immunoassays: Elecsys 
EBV IgM, Elecsys EBV VCA IgG, and Elecsys EBV EBNA IgG, that detect 
antibodies specific to the Epstein-Barr virus (EBV), at different stages 
of infection. When used in combination, the three tests can help to 
define how far the infection has progressed in a patient. 
 
   Epstein-Barr Virus is one of the most common viruses in humans, 
infecting more than 90% of the global population by adulthood.(1-2) It 
is mainly transmitted by saliva, or via organ or cell transplants. After 
the first infection, EBV remains in a dormant state for life. Clinical 
symptoms vary according to the immune status of the patients and people 
with weakened immune systems may develop more severe symptoms. 
 
   "The launch of the Elecsys EBV panel is an important step for the 
diagnosis of infections in transplant patients as it gives clear and 
accurate results from a single sample", said Thomas Schinecker, CEO 
Roche Diagnostics. "The tests help to provide the information clinicians 
need to diagnose and treat their patients quickly, effectively reducing 
the need for further confirmatory testing." 
 
   EBV testing with immunoassays, from a blood sample, has a number of 
clinical uses. EBV is used to confirm the diagnosis of glandular fever 
in people with clinical signs and symptoms and to rule out other acute 
diseases with a similar clinical picture, such as certain infections in 
pregnant women that may cause congenital disorders. Knowing the EBV 
status of donors and recipients of organ and cell transplants is 
important, as recipients typically have a weaker immune system and may 
be at risk of complications.(3-5) 
 
   Routine EBV testing and result interpretation can be challenging, and 
additional testing is required for EBV infection stages in as many as 
5-10% of normal samples, where the stage of infections is not 
clear.(6-10) The Elecsys EBV panel correctly classifies a high 
percentage of routine samples, when determining the stage of EBV 
infection. This means that less confirmatory testing is required, saving 
time and resources for the laboratory, as well as potentially leading to 
more effective patient management. 
 
   About Epstein-Barr Virus (EBV) Testing 
 
   While there is no international serological standard or consensus 
algorithm defined for EBV serology testing, there are different ways of 
conducting the EBV blood tests. Often the three immunoassays used to 
determine the stage of EBV infection are run in parallel. However, in an 
immunocompetent, adult population, the number of tests per sample can be 
reduced up to 50%, by using the "EBNA-first" sequential algorithm. 
Approximately, 70-80% of routine samples for EBV testing indicate past 
infections, and only 2.4% are acute infections.(3) Therefore, by 
determining the Epstein-Barr nuclear antigen 1 (EBNA-1) results first, a 
positive result will rule out all past infections, meaning that only 
EBNA-1 negative samples will have to be further tested for the presence 
of IgM and VCA IgG antibodies to determine the final EBV infection 
stage. This further reduces costs and increases the efficiency of the 
laboratory testing. The high specificity and sensitivity of the Elecsys 
EBV EBNA IgG, in combination with clearly defined results, makes this 
assay very well suited for the implementation of the "EBNA-first" 
algorithm and thus brings greater value to laboratories and patients 
through more cost effective and efficient testing.(11) 
 
   About the Elecsys EBV immunoassay panel 
 
   The Elecsys(R) EBV panel consists of three immunoassays to detect 
antibodies specific to the Epstein-Barr virus (EBV). The three assays, 
Elecsys(R) EBV IgM, Elecsys(R) EBV VCA IgG, and Elecsys(R) EBV EBNA IgG 
are used in combination to accurately determine the patient's EBV 
infection stage. The immunoassays have excellent clinical sensitivity 
and specificity, and a short time to result of only 18 minutes. The 
tests require a small sample volume of between 6 L to 35 L, 
depending on the assay and analyzer. The addition of the EBV panel isd 
an important addition to the routine infectious diseases testing panel 
for Roche's immunoassay portfolio. 
 
   This further addition to the Roche EBV testing portfolio follows on from 
the announcement of the CE Mark and FDA authorisation for the first 
Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to 
improve care for transplant patients. 
 
 
 
   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 
twelfth 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 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 
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www.roche.com. 
 
 
 
   All trademarks used or mentioned in this release are protected by law. 
 
 
 
   References 
 
   [1] Balfour HH, Jr, et al..  J Infec Dis. 2013;208(8):1286-93. 
 
   [2] Dudley et al. Nephron Clin Prac (2011) 118 Suppl 1:c209-24 , 
 
   [3] EDQM. 7th edition. 
 
   [4] Padalko et al, Cell Tissue Bank (2018;)19(4):681-95, 
 
   [5] Nowalk A and Green M.. Microbiol Spectr. 2016;4(3). 
 
   [6] De Paschale and Clerici World J Virol. 2012;1(1):31-43, 
 
   [7] Niller HH and Bauer G. Methods in Molecular Biology; 2017. 
 
   [8] Klutts et al. J ClinMicrobiol , 2009 :81(2):325-331. 
 
   [9 De Paschale et al. J Med Virol 2009;81(2):325-331. 
 
   [10] Vetter et al. Clin Diagn Virol 1994;2(1):29-40. 
 
   [11] Sickinger et al. Diagn. Microbiol. Infect. Dis. 2014, 79, 310-316. 
 
 
 
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