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Fierce Biotech·7h ago·2 min read
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Labcorp launches new hepatitis D test to find patients with most severe form of virus

Labcorp is looking to plug the gap in hepatitis D monitoring with a new reflex testing solution to help find more patients with this form of the virus earlier.

Aug 25, 2026·read at Fierce Biotech ↗

MedTech Labcorp launches new hepatitis D test to find patients with most severe form of virus By Ben Adams Aug 25, 2026 1:22pm Labcorp hepatitis D Roche Gilead Sciences Labcorp is looking to plug the gap in hepatitis D (HDV) monitoring with a new reflex testing solution to help find more patients with this form of the virus earlier. Hepatitis D only occurs in people with hepatitis B and is considered the most severe form of viral hepatitis. The disease can increase the risk of liver cirrhosis, liver cancer and other serious complications.

Labcorp says however that “many eligible patients are never evaluated for coinfection.” Testing has often been limited to manual methods or lab-developed tests that can vary in consistency. Labcorp is looking to change that with its new HDV reflex testing option, which falls within its Comprehensive Hepatitis Testing portfolio. As part of this new test, clinicians can now select a reflex testing option that automatically performs hepatitis D testing on the original blood sample when hepatitis B is found.

This means extra blood draws or orders for new testing can be eliminated. Labcorp estimates between 70,000 to 150,000 people in the U.S. are living with an active HDV infection but found that fewer than 20% of hepatitis B-positive patients are tested for the disease.

“This gap in testing contributes to substantial underdiagnosis and delays in care,” the company said in a statement. Related Norgine gets in on Vir's hepatitis D program with €550M European licensing pact Labcorp said that as part of this launch, it is also offering “enhanced hepatitis B reporting with simplified result interpretations designed to support clinical decision-making.” It’s been a good year for innovation in the HDV space. Just last month Roche introduced its new cobas Hepatitis D Virus test.

This became the first high-throughput, fully automated HDV assay on the market. Back in May, Gilead’s Hepcludex also became the first treatment for chronic HDV infection in the United States. Labcorp hepatitis D Roche Gilead Sciences Diagnostics MedTech

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Reporting by Fierce Biotech.

read at Fierce Biotech ↗
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companies & drugs in this story

companies
GILEAD3ROCHE3GILEAD SCIENCES INC2
topics
Hematology2Hepatology2Infectious Disease2Medical Device Company2Diagnostics CompanyOncology

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