Hepatitis E

The launch of the quantitative and qualitative hepatitis B test comes shortly after Roche’s last addition to its hepatitis diagnostics slate. Earlier this month the company launched two immunoassays for detecting hepatitis E. For the second time this month, Roche is launching a new immunoassay to help diagnose cases of hepatitis. This time around, the newly unveiled test is one designed to identify the hepatitis B e antigen (HBeAg) in samples of human serum and plasma. The test, launched in Europe, not only detects the presence of the antigen, but also measures its quantity, meaning it can help measure the extent of a patient’s condition and their response to therapy. The Elecsys HBeAg quant test runs on Roche’s Cobas e-series analyzers and is available in all countries that recognize CE mark approval, according to the company’s announcement Monday. The test is meant to be used even after helping with the initial hepatitis B diagnosis. For one, because it quantifies the presence of the antigen, it can be administered to help monitor the effects of various treatments. For another, according to Roche, it can be used alongside other hepatitis B diagnostics to determine the phase of the disease, as well as how the virus is affecting the liver and the chances it may progress into liver cancer or other conditions. Roche noted that the immunoassay’s potential impact could be particularly large, since hepatitis B is the most common type of viral hepatitis around the world. “Hepatitis B affects millions of people each year and is a major global health burden. An accurate diagnosis is critical to ensuring timely treatment options,” Matt Sause, CEO of Roche Diagnostics, said in the announcement. “If hepatitis B is left untreated, it can cause chronic infections, putting people at high risk of death from cirrhosis and liver cancer.” He continued, “The addition of the Elecsys HBeAg quant immunoassay to our viral hepatitis testing portfolio underlines Roche’s commitment to tackle healthcare’s biggest challenges to support clinicians and their patients.” The launch of the quantitative and qualitative hepatitis B test comes shortly after Roche’s last addition to hepatitis diagnostics slate. Earlier this month the company announced the launch of two immunoassays for catching cases of hepatitis E. One of the Elecsys Anti-HEV tests looks for IgM antibodies to the hepatitis E virus, while the other focuses on IgG antibodies. The former can be used to detect both acute and recently acquired cases of the virus, while the latter broadens the scope to identify either recent or past infections. Roche’s debut comes as the World Health Organization has added hepatitis E diagnostics to its annual Essential Diagnostics List for the first time, and as estimates suggest that one-third of the world’s population could be at risk of infection, according to data cited by Roche. As with the hepatitis B test, the HEV tests are meant to run on certain Cobas e-series analyzers and modules. They return results in about 18 minutes, per their maker, and round out Roche’s panel of tests to differentiate between different forms of acute hepatitis.

The Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG tests are intended for in-vitro qualitative detection of IgM antibodies and IgG antibodies to HEV respectively, in human serum and plasma to help detect acute, recently acquired or past HEV infections Roche administration and R&D buildings in Rotkreuz. (Credit: F. Hoffmann-La Roche Ltd) Roche has introduced the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays to detect hepatitis E virus (HEV) infections, in countries that accept the CE mark. The Elecsys Anti-HEV IgM is designed for in-vitro qualitative detection of IgM antibodies to HEV in human serum and plasma, to help detect an acute or recently acquired HEV infection. Its Elecsys Anti-HEV IgG is intended for the in vitro quantitative determination of IgG antibodies to HEV in human serum and plasma, to help detect a recent or past HEV infection. Both are fully automated assays and provide results within 18 minutes. The World Health Organization (WHO) has developed an ‘Essential Diagnostics List’ comprising necessary in-vitro diagnostics to ensure timely and life-saving diagnoses in all countries. The Swiss healthcare company said that its HEV tests have been added to the list for the first time this year, to aid the diagnosis and surveillance of HEV infection. Roche Diagnostics CEO Matt Sause said: “These tests highlight Roche’s commitment to contributing to the elimination of infectious diseases globally. Infection with HEV, a virus of significant global impact, results in 70,000 deaths and 3,000 stillbirths annually. “The Anti-HEV IgM inclusion in the newly released WHO 2023 Essential Diagnostics List, demonstrates the important role this test plays in disease management for patients globally.” The testing for HEV infection would help clinicians identify the symptoms of their patients, determine appropriate treatment, and monitor and prevent its progression to severe disease. HEV testing also contributes to managing infected patients in high-risk groups and avoiding the misdiagnosis of drug-induced liver injury. They will also help to provide a more accurate estimate of the global HEV disease burden and inform governments and public health stakeholders on how to respond to the disease globally. Roche said that its two new HEV tests require smaller sample volumes than manual tests and help lab personnel run them more effectively compared to manual tests. Both assays were evaluated in a multi-centre study of more than 8,900 samples from people with suspected HEV infection, hospitalised patients, blood donors and pregnant women. The Elecsys Anti-HEV IgM assay showed an overall relative sensitivity and specificity of 98.7% and 99.4%, while Elecsys Anti-HEV IgG showed 99.1% sensitivity and 99.8% specificity. In a separate development, Roche is reported as planning to invest $240m in Colombia over the next five years, as part of its plan to consolidate its presence in the country. The Swiss healthcare company already invested $40m this year, with the inauguration of a new distribution centre on the outskirts of Bogota.

It is estimated that one third of the global population could be at risk for infection with Hepatitis E virus.1The new tests allow clinicians to diagnose acute and chronic infections amongst patients presenting with or without signs of the illness as recommended by the European Association for the Study of the Liver (EASL).2The tests complete Roche’s panel used for the differential diagnosis of acute viral hepatitis caused by the hepatitis A, B, C and E viruses. Basel, 16 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark. By testing for HEV infection, clinicians can support their patients to identify the cause of their symptoms and determine appropriate treatment, monitor for progression to severe acute HEV and prevent severe disease progression with antiviral treatment.1,2,6 Recognising the value of diagnostics, the World Health Organization (WHO) has developed an “Essential Diagnostics List” which includes in-vitro diagnostics that should be available in all countries to increase timely and life-saving diagnoses. This year for the first time, tests for HEV are included to aid in the diagnosis and surveillance of HEV infection.5 “These tests highlight Roche’s commitment to contributing to the elimination of infectious diseases globally. Infection with HEV, a virus of significant global impact, results in 70,000 deaths and 3,000 stillbirths annually,”3,4 said Matt Sause, CEO of Roche Diagnostics. “The Anti-HEV IgM inclusion in the newly released WHO 2023 Essential Diagnostics List, demonstrates the important role this test plays in disease management for patients globally. HEV testing also contributes to managing infected patients in high-risk groups and avoiding the misdiagnosis of drug-induced liver injury.1,2,6 They will also help to provide a more accurate estimate of the global HEV disease burden and inform governments and public health stakeholders on how to respond to the disease globally.5 As HEV is under-reported, the addition of these tests will support governments in managing outbreaks. These fully automated assays will support lab personnel by enabling them to run them more efficiently compared to manual tests, as they require smaller sample volumes than manual tests, enabling results to be available within 18 minutes. About the Elecsys Anti-HEV IgM and Anti-HEV IgG immunoassaysElecsys Anti-HEV IgM is an immunoassay for the in vitro qualitative detection of IgM antibodies to HEV in human serum and plasma, and is used as an aid to detect an acute or recently acquired HEV infection. Elecsys Anti-HEV IgG is an immunoassay for the in vitro quantitative determination of IgG antibodies to HEV in human serum and plasma, and is used as an aid to detect a recent or past HEV infection. The performance of both assays was evaluated in a multi-center study, which tested a total of more than 8,900 samples from presumed acute and recovered HEV infection for the determination of relative sensitivity, and from hospitalized patients, blood donors and pregnant women for the determination of relative specificity. The overall relative sensitivity of the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG assay was determined as 98.7% (95% CI 97.3 – 99.5%) and 99.1% (95% CI 98.0 – 99.7%), respectively. The overall specificity was determined as 99.4% (95% CI 99.2 – 99.6%) and 99.8% (95% CI 99.6 – 99.9%), respectively. The new assays are available for use on the cobas® e 411 analyzer, cobas e 601/602 modules, and the cobas e 402 and cobas e 801 analytical modules. They expand Roche’s comprehensive viral hepatitis serology test portfolio, and complete the test panel used for the differential diagnosis of acute hepatitis caused by the hepatitis A, B, C and E viruses (alongside the Elecsys Anti-HAV IgM, Elecsys Anti-HBc IgM, Elecsys HBsAg II, Elecsys Anti-HCV II, and Elecsys HCV Duo assays). About the World Health Organisation’s (WHO) 2023 Essential Diagnostics List (EDL)The World Health Organisation’s (WHO) 2023 Essential Diagnostics List (EDL) is an evidence-based register of in vitro diagnostics that supports countries to make national diagnostic choices. Updated biennially, the EDL is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and clinical laboratory services. As well as informing national EDLs, it provides advice on prioritization of IVDs at different levels of the healthcare system. Additionally, it informs United Nations agencies and non-government organizations that support the selection, procurement, supply or donation of In Vitro Diagnostics along with guidance to the private health technology and manufacturing sectors about the IVDs priorities required to address global health issues.5 About hepatitis E virus (HEV)HEV is a pathogen of growing global public health concern.7,8 HEV includes 8 genotypes, of which HEV-1 to 4 are the most frequently detected globally. HEV-1 and HEV-2 infect only humans, whereas HEV-3 and HEV-4 can infect both humans and animals such as pigs, wild boar, rabbits and deer.9-15 It is estimated that HEV-1 and HEV-2 account for approximately 20.1 million HEV infections, 3.4 million symptomatic cases, 70,000 deaths, and 3000 stillbirths annually.3 HEV-1 and HEV-2 are commonly found in developing countries with poor sanitation, where HEV is transmitted through the fecal-oral route.7,10, 16 HEV-3 accounts for most of the sporadic HEV infections in developed countries while HEV-4 is mainly found in Asia. Both HEV-3 and HEV-4 are transmitted zoonotically, most commonly through undercooked meat.7,17,18 In several countries, occasional transmission of HEV-3 and HEV-4 through blood transfusion has been reported.7, 19,20 HEV infection usually causes a mild or subclinical infection with a self-limiting illness that lasts from 2 to 6 weeks.21, 22 Symptomatic hepatitis E is similar to other acute hepatitis infections (fatigue, nausea, vomiting as well as jaundice and elevated liver enzymes).21 High-risk populations are immunocompromised patients (specifically transplant organ recipients),22,21,23,24 patients with underlying liver conditions, and elderly people and pregnant women.9,19,13,25-27 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 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] Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:1-18[2]EASL. Clinical Practice Guidelines on hepatitis E virus infection. J Hepatol 2018;68:1256-1271[3] World Health Organization (WHO). Hepatitis E vaccine: WHO position paper. Wkly Epidemiol Rec. 2015;18:185-200.[4] Rein DB, et al. The global burden of hepatitis E genotypes 1 and 2 in 2005. Hepatology. 2012;55:988-997.[5] World Health Organization. WHO releases new list of essential diagnostics; new recommendations for hepatitis E virus tests, personal use glucose meters [Internet; updated 2023 Oct 19; cited Nov 2 2023]. Available from https://www.who.int/news/item/19-10-2023-who-releases-new-list-of-essential-diagnostics--new-recommendations-for-hepatitis-e-virus-tests--personal-use-glucose-meters[6] Kar P, Karna RA. A Review of the Diagnosis and Management of Hepatitis E. Curr Treat Options Infect Dis 2020;12:310–320[7] Khuroo MS, et al. Hepatitis E: Discovery, global impact, control and cure. World J Gastroenterol. 2016;22:7030-7045.[8] Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:2049936119837162.[9] Li P, et al. The global epidemiology of hepatitis E virus infection: A systematic review and meta-analysis. Liver Int. 2020;40(7):1516-1528.[10] Goel A, Aggarwal R. Hepatitis E: Epidemiology, Clinical Course, Prevention, and Treatment. Gastroenterol Clin North Am. 2020;49:315-330.[11] Raji YE, et al. Hepatitis E Virus: An emerging enigmatic and underestimated pathogen. Saudi J Biol Sci. 2022;29:499-512.[12] Kamar N, et al. Hepatitis E. Lancet. 2012;379:2477-2488.[13] Aggarwal R, Goel A. Natural History, Clinical Manifestations, and Pathogenesis of Hepatitis E Virus Genotype 1 and 2 Infections. Cold Spring Harb Perspect Med. 2019;9:a032136.[14] Smith DB, et al. Update: proposed reference sequences for subtypes of hepatitis E virus (species Orthohepevirus A). J Gen Virol. 2020;101:692-698.[15] Purdy MA, et al. ICTV Virus Taxonomy Profile: Hepeviridae. 2022. J Gen Virol 2022;103(9).[16] Ruggeri FM, et al. Zoonotic transmission of hepatitis E virus in industrialized countries. New Microbiol. 2013;36:331-44.[17] Izopet J, et al. Hepatitis E virus infections in Europe. J Clin Virol. 2019;120:20-26.[18] World Health Organisation. Factsheet Hepatitis E. Last updated June 2022 [Internet, updated 2023 July, cited 2023 July 24]. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.[19] Al-Sadeq DW, et al. Laboratory challenges in the diagnosis of hepatitis E virus. J Med Microbiol. 2018;67(4):466-480.[20] Pérez-Gracia MT, et al. Hepatitis E: an emerging disease. Infect Genet Evol. 2014;22:40-59.[21] Kamar N, et al. Hepatitis E virus infection. Nat Rev Dis Primers. 2017;3:17086.[22] Lhomme S, et al. Hepatitis E Pathogenesis. Viruses. 2016;8:212.[23] Larrue H, et al. Hepatitis E, what’s the real issue? Liver Int. 2020;40(Suppl 1):43-47.[24] Lhomme S, et al. Risk of zoonotic transmission of HEV from rabbits. J Clin Virol. 2013;58:357-362.[25] Zhao Q, et al. Antigenic determinants of hepatitis E virus and vaccine-induced immunogenicity and efficacy. J Gastroenterol. 2013;48:159-168.[26] Aggarwal R. Hepatitis E: clinical presentation in disease-endemic areas and diagnosis. Semin Liver Dis. 2013;33:30-40.[27] Velavan TP, et al. Hepatitis E: An update on One Health and clinical medicine. Liver Int 2021;41:1462-1473. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Nathalie AltermattPhone: +41 79 771 05 25 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 16112013_MR_Launch of Elecsys Anti-HEV IgM & Anti-HEV IgG_en