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  • Mar
    16
    2021

    December, 2020: ImCare Biotech publishes clinical study results for Seravue® demonstrating high sensitivity and specificity for the detection of liver cancer

    ImCare Biotech recently published the results from its clinical study in the peer-reviewed journal Clinical and Translational Gastroenterology. The study, which was a prospective, double-blinded study, assessed Seravue’s ability to differentiate between patients with Hepatocellular Carcinoma (HCC), and benign liver conditions such as cirrhosis and chronic Hepatitis B and C. For any-stage HCC patients, Seravue demonstrated a sensitivity of 80% and a specificity of 90%, while for early-stage HCC (BCLC stage 0 and stage A) patients, Seravue demonstrated a 72% sensitivity and 90% specificity. This was significantly higher than the performance of alpha-fetoprotein (AFP), the most commonly used biomarker for HCC detection today, which demonstrated 52% sensitivity and 86% specificity for HCC overall (only 42% sensitivity for early-stage HCC).

    ImCare is pleased that the promising results of our study have been published and demonstrate the potential of our diagnostic test, and looks forward to the continued development of our diagnostic technology in order to improve health outcomes for all patients affected by liver disease.

    A link to the publication can be found here.

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← June, 2020: FDA grants Breakthrough Device Designation for Seravue® to support earlier diagnosis of Liver Cancer using a simple blood test
January, 2021: The Centers for Medicare and Medicaid (CMS) announced the MCIT pathway to provide national Medicare coverage for FDA Breakthrough Devices and Diagnostic →
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