HepatoDetect is an innovative in vitro diagnostics medical device

Liver Cancer

Liver cancer is the sixth most commonly diagnosed cancer and the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common form of liver cancer comprising 75% – 85% of cases 1,2, of which, 80% – 90% develop in a background of liver cirrhosis3,4. HCC diagnosis, particularly during the early stages of the disease, is critical for successful early curative therapeutic interventions and, consequently, for patient survival2,5. Clinically, HCC routine screening in cirrhotic patients is mainly based on ultrasound analysis of the liver and serum protein marker alpha-fetoprotein (AFP) levels every 6 months. However, this diagnostic approach has shown a sensitivity of only 63%6–8.

HepatoDetect

HepatoDetect is an innovative in vitro diagnostics medical device. It is based on a liquid biopsy and is aimed at early detection of liver cancer. It was developed for screening at risk patients, like those suffering from liver cirrhosis, who have a significant probability of developing HCC, and to monitor HCC patietns that have been subject to locoregional therapies, or to surgical ressection or liver transplantation, who are at risk of a relapse.

How it works

HepatoDetect is a non-invasive blood-based liquid biopsy test to analyse the differential methylation in tumour-derived cell-free DNA with high specificity and sensitivity. It is based on DNA methylation signature discovered by Ophiomics and a proprietary machine learning algorithm9 that  together are predictive of HCC in a background of cirrhosis, in both tissue DNA and LB cfDNA samples.

Who is it for?

We developed HepatoDetect to support gastroenterologists, hepatologists and hepatobiliary surgeons in their effots to detect liver cancer early at a stage where treatments still result in significantly improved patient outcomes.  HepatoDetect empowers these professionals to:

  • Detect liver cancer early in the context of screening at risk patients with liver cirrhosis while curative-intent interventions are still possible
  • Detect relapse following locoregional or surgical interventions, permiting the timely orientation of the patient to additional treatment.

Availability

HepatoDetect is not commercially available yet. If you want to participate in the prospective validation of HepatoDetect, get in touch

References

1 Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021;71(3):209–49.

2 Parra NS, Ross HM, Khan A, et al. Advancements in the Diagnosis of Hepatocellular Carcinoma. International Journal of Translational Medicine 2023;3(1):51–65.

3 Perera Mesa H, Lugo L, Altshuler E. Hepatocellular Carcinoma in Patients With Liver Cirrhosis Secondary to Autoimmune Hepatitis: A Case Series and Literature Review. Cureus 2022;14(10):e30698.

4 Tarao K, Nozaki A, Ikeda T, et al. Real impact of liver cirrhosis on the development of hepatocellular carcinoma in various liver diseases—meta‐analytic assessment. Cancer Med 2019;8(3):1054–65.

5 Ge X-Y, Sun M-C, Wang T-Y, et al. Analysis of risk factors of hepatocellular carcinoma and establishment of a clinical prognosis model. Front Oncol 2023;13:1067353.

6 Li Y, Zheng Y, Wu L, et al. Current status of ctDNA in precision oncology for hepatocellular carcinoma. Journal of Experimental and Clinical Cancer Research. 2021;40(1):140.

7 Luo B, Ma F, Liu H, et al. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med 2022;20(1):8.

8 Pinto Marques H, Gomes da Silva S, De Martin E, Agopian VG, Martins PN. Emerging biomarkers in HCC patients: Current status. International Journal of Surgery 2020;82:70–6.

9 Gonçalves E, Gonçalves-Reis M, Pereira-Leal JB, Cardoso J. DNA methylation fingerprint of hepatocellular carcinoma from tissue and liquid biopsies. Sci Rep 2022;12(1):11512.