Roche grows hepatitis diagnostics roster with new immunoassays

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.