A straightforward and highly reproducible molecular assay

HepatoPredict uses tumour biomarkers and clinical variables

Most criteria for the selection of patients with Hepatocellular Carcinoma (HCC) for liver transplantation use information from image-based diagnosis (e.g.: number of nodules, nodule diameter, and/or volume) and surrogate tumour markers (e.g.: AFP levels).

HepatoPredict addresses the expression level of 4 genes at tumour level by RT-qPCR. This gene expression signature and three clinical variables are integrated through an algorithm. HepatoPredict outputs prognostic information in the form of a simple and objective clinical report classifying patients based on the likelihood of disease recurrence.

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The HepatoPredict workflow

HepatoPredict is a CE-marked IVD and UK-marked CA prognostic test with ISO 13485 certification.

One kit provides all the reagents needed to run one patient sample from RNA isolation to gene expression signature evaluation by RT-PCR and access to test report through MyOphiomics. We provide comprehensive support for setting up the protocol in laboratories implementing HepatoPredict.

1. Tumour sample

A formalin fixed and paraffin-embedded (FFPE) tissue sample with at least 20mm2  of tumour tissue is required to perform HepatoPredict.

  • 2x FFPE tumour section
  • 1 slide stained with H&E to guide macrodissection

2. RT-qPCR (molecular assay)

The molecular assay was subjected to analytical validation (Gonçalves-Reis et al. 2024) and includes several steps:

  • RNA isolation by column-based method;
  • RNA quality assay by RT-qPCR;
  • HepatoPredict gene signature assay by RT-qPCR.
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The use of HepatoPredict has been validated for the following equipments:

3. Algorithm

  • HepatoPredict addresses the expression level of 4 genes at tumour level (DPT, CLU, CAPNS1, and SPRY2) by RT-qPCR.
  • This gene expression signature and three clinical variables (number of tumours, size of largest tumour, and total tumour diameter) are integrated through an algorithm in the MyOphiomics portal.

MyOphiomics

A simple report with the result will be available in the MyOphiomics portal to download.

4. Result

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The test output gives information on the likelihood of disease progression for the patient, i.e., whether the patient is predicted to relapse or not. This gives medical teams the possibility to better select candidates for liver transplantation and/or to identify transplanted patients at risk of disease progression, thus enhancing patient management strategies.

HepatoPredict should be used in conjunction with standard laboratory and clinical assessments, consistent with established practices. HepatoPredict does not endorse any specific laboratory or clinical measure; rather, it should be integrated with local clinical standards for comprehensive patient evaluation.

References

  • Pinto-Marques and Cardoso et al (2022) A gene expression signature to select hepatocellular carcinoma patients for liver transplantation. Annals of Surgery. doi: 10.1097/SLA.0000000000005637.
  • Gonçalves-Reis M et al (2024) Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation. Pract Lab Med. 2024 Feb 5;39:e00365. doi: 10.1016/j.plabm.2024.e00365.
  • Reig M et al (2022) BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2022 Mar;76(3):681-693. doi: 10.1016/j.jhep.2021.11.018. Epub 2021 Nov 19.