Roche launches innovative dual antigen and antibody

  • Elecsys HCV Duo is the first commercially available immunoassay that allows the simultaneous and independent determination of the antigenic and antibody status of the hepatitis C virus (HCV).
  • The Elecsys HCV Duo immunoassay allows much earlier diagnosis of active HCV infection, leading to earlier appropriate patient care to arrest both disease progression and transmission.

Basel, July 18, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys® HCV Duo immunoassay in countries that accept CE marking. Elecsys HCV Duo is the first available immunoassay that allows the simultaneous and independent determination of hepatitis C virus (HCV) antigen and antibody status from a single sample of human plasma or serum. This means the test can be used to detect the early stage of infection, as well as when the patient is recovering from the virus or showing signs of a chronic infection that can lead to other diseases, such as liver cancer.

By utilizing the dual detection of HCV core antigen and HCV antibodies, the Elecsys HCV Duo test enables significantly earlier diagnosis of active hepatitis C virus infection compared to HCV tests. antibodies alone, as the core antigen appears early in infection and is a marker of ongoing viral replication. This can lead to earlier intervention for patients, a reduction in the number of clinic visits needed to collect additional test samples, and can alleviate some of the testing burden on health systems.

“Through better hepatitis screening, healthcare systems have the opportunity to eliminate the disease through improved prevention, screening and treatment services,” said Thomas Schinecker, CEO of Roche Diagnostics. “Adding the Elecsys HCV Duo test to our HCV testing portfolio can help in the fight to eliminate the hepatitis C virus. The launch of this innovative dual antigen and antibody diagnostic test underscores our commitment to helping clinicians and their patients to reduce the impact of infectious diseases, where they are needed most.

In 2019, 58 million people were living with chronic HCV infection, but only 21% were aware of it.1 290,000 people died of hepatitis C-related causes, such as cirrhosis and liver cancer, more than those due to HIV or malaria. Although there is no vaccine available against HCV, there is an effective treatment with antivirals that can lead to the cure of 98% of patients.1 However, to find affected populations, there is more emphasis on increased access and uptake of testing to reduce the impact of the virus, as well as to provide better disease management for patients whose HIV test HCV is positive.3

Through early detection and intervention, it is possible to provide patients with appropriate care sooner, halt disease progression and transmission, and potentially reduce unnecessary healthcare costs. Addressing these factors is crucial in efforts to eradicate the disease. Currently, there are significant gaps in access to hepatitis C testing and treatment in all populations, particularly among economically disadvantaged populations, as well as those living in rural areas.

About Elecsys HCV Duo immunoassay
Elecsys® HCV Duo is an immunoassay for the qualitative in vitro determination of hepatitis C virus (HCV) core antigen (HCV Ag) and anti-HCV antibodies (anti-HCV) in serum and plasma humans. The test, in conjunction with other laboratory results and clinical information, can be used to aid in the diagnosis and screening of HCV infection. The test can also be used as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissues and organs. The sub-results (HCV Ag and anti-HCV) are intended to aid in the selection of confirmatory testing algorithm for reactive specimens.

The “ECLIA” electrochemiluminescence immunoassay is intended for use on the cobas e 801 and cobas e 402 immunoassay analyzers.

About hepatitis VS
Hepatitis C is an inflammatory disease of the liver caused by infection with the hepatitis C virus (HCV). According to the World Health Organization, 1.5 million people were newly infected with HCV in 2019.2 About 58 million people are chronic carriers of the hepatitis C virus, and most do not know they are infected.2 The disease can ultimately lead to cirrhosis, liver failure and hepatocellular carcinoma, which together are responsible for hundreds of thousands of deaths each year. While the momentum to tackle viral hepatitis is building, progress in service delivery is still insufficient. Only 21% of people living with chronic hepatitis C infection know their status. 9.4 million people chronically infected with HCV were receiving treatment at the end of 2019, a 10-fold increase from the million people receiving treatment at the end of 2015, but treatment coverage is only 13% of people in need.2 Causes of the spread of hepatitis include percutaneous exposure to blood (for example, by sharing needles, improperly sterilized medical equipment, needlestick injuries in healthcare, unsanitary tattoos/piercings, blood/blood product transfusions, haemodialysis), organ and tissue transplants, sexual contact or being transmitted from an infected mother to her fetus.4 These populations are central to existing testing protocols.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded drugs, Roche has become the world’s largest biotechnology company and the world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way 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 pharmacy with insights from clinical practice.

In recognition of our efforts to pursue a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare with local partners in all the countries where we work.

Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this press release are protected by law.

References
[1 ]Global status report on HIV, viral hepatitis and sexually transmitted infections, 2021. Accountability for global health sector strategies 2016-2021: actions for impact. Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO. https://www.who.int/publications/i/item/9789240027077
[2] WHO. (2021). Hepatitis C fact sheet. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c– July 2021
[3] World Hepatitis Alliance (WHA), 2021. https://www.worldhepatitisday.org/
[4] World Health Organization (2021). Global status report on HIV, viral hepatitis and sexually transmitted infections, 2021. Accountability for global health sector strategies 2016-2021: actions for impact. https://www.who.int/publications/i/item/9789240027077

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