Roche expands hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection
2023年11月27日 - 3:00PM
Roche expands hepatitis diagnostics portfolio to help clinicians
diagnose and monitor patients with acute or chronic hepatitis B
infection
- Elecsys® HBeAg quant is an
immunoassay that can be used as an early marker of acute hepatitis
B infection, as well as an indicator of chronic active hepatitis in
combination with other laboratory results and clinical
information.
- The single test will inform
clinicians if treatment is required and regimens are working in
conjunction with other diagnostic assays.
- Almost 300 million people
globally have chronic hepatitis B, causing a significant burden to
health systems as it puts patients at high risk of death from
cirrhosis and liver cancer.1
Basel, 27 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced the launch of Elecsys® HBeAg quant, an immunoassay
that is able to determine both the presence and quantity
(qualitative and quantitative) of the hepatitis B e antigen (HBeAg)
in human serum and plasma. This launch means that, when combined
with other laboratory results and clinical information, patients
will now get confirmation on whether they have hepatitis B (HBV),
and if so, to what extent, as well as treatment monitoring through
one single assay. It is for use on the cobas® e analysers in
countries accepting the CE Mark. HBV is the most common type of
viral hepatitis affecting people of all ages, posing a significant
burden on people and healthcare systems globally.1
The new Elecsys HBeAg quant test will complement existing HBV
testing markers. When a patient with suspected HBV returns a
positive result of HBeAg, clinicians can determine the patient’s
disease phase,2,3 assess the activity of the virus in the liver4
and risk of progressive liver disease and Hepatocellular carcinoma
(HCC).5,6
“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. If hepatitis B is left untreated, it can
cause chronic infections, putting people at high risk of death from
cirrhosis and liver cancer," said Matt Sause, CEO of Roche
Diagnostics. "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 new diagnostic tool reduces complexity and improves
operational efficiency thanks to a leaner workflow for lab
personnel. It can also simplify the experience for patients, as
they only have to undergo one single test to indicate both the
presence and quantity of HBeAg. The qualitative result provided by
the test can help diagnose patients with HBeAg as an early marker
of acute HBV, as well as indicate chronic or active HBV. The
additional quantitative answer will enhance patient management
enabling the most appropriate treatment plan for patients.
The Elecsys HBeAg quant can also be used as a tool in perinatal
screening7 and to monitor antiviral treatment response within
infected patients, potentially supporting the implementation of a
therapeutic plan tailored to individual patient’s needs.
About the Elecsys HBeAg quant
immunoassayElecsys® HBeAg quant is an immunoassay for the
in vitro qualitative and quantitative determination of hepatitis B
e antigen (HBeAg) in human serum and plasma. In conjunction with
other laboratory results and clinical information, HBeAg
quantification may be used as an aid for the diagnosis and
monitoring of patients with hepatitis B viral infection. Elecsys®
HBeAg quant reports both a qualitative and a quantitative readout,
providing greater value to clinicians and patients. The test can be
used for samples from patients with unknown HBeAg status (first
line testing) as well as those who have previously tested positive
(second line testing). The immunoassay is intended for use on all
available cobas e analysers.
About hepatitis BHBV is a viral infection that
attacks the liver and can cause both acute and chronic disease.1 It
is the most common type of viral hepatitis affecting people of all
ages, posing a significant burden on people and healthcare systems
globally.1 In 2019, WHO estimated that 296 million people were
living with chronic hepatitis B infection, with 1.5 million new
infections each year. In this same year, hepatitis B resulted in an
estimated 820,000 deaths, mostly from cirrhosis and hepatocellular
carcinoma (primary liver cancer). The virus is most commonly
transmitted from mother to child during birth and delivery, as well
as through contact with blood or other body fluids during sex with
an infected partner, unsafe injections or exposures to sharp
instruments.1 While a vaccine exists to prevent HBV, there is
currently no cure for patients who have been diagnosed with the
infection.
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 endeavor 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] WHO 2023. Hepatitis B Fact
sheet. Available at:
https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-b,
accessed April 2023[2] EASL 2017. J Hepatol 2017; 67:370–398. [3]
Wong GL, et al. Clin Infect Dis 2016;62(Suppl 4):S298–S305.[4]
Fletcher GJ, et al. J Clin Lab Anal 2016;30:1146–1149. [5] WHO.
2017.
https://www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/
[6] Yang HI, et al. N Engl J Med 2002;347:168–174. [7]
Mixson-Hayden T, et al. J Clin Virol 2018;109:22–28.
Roche Group Media RelationsPhone: +41 61 688
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