Biocartis initiates commercialization in Europe of HepatoPredict (CE-IVD) test for liver cancer patients
Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the start of the commercialization in Europe of the HepatoPredict test as a CE-IVD marked manual kit. The test, developed by Ophiomics, is a prognostic diagnostic test that supports the decision of liver transplantation in patients with Hepatocellular Carcinoma (HCC).
Primary liver cancer (1) is the sixth most common and third most lethal cancer in the world (2)
Biocartis to initiate commercialization in Europe of HepatoPredict, a prognostic gene expression signature test developed by its partner Ophiomics, to identify which liver cancer patients with Hepatocellular Carcinoma (HCC) will benefit from liver transplantation
Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very excited to initiate commercialization of HepatoPredict in Europe. Thanks to our well-established European base of customer-labs, together with Ophiomics, we will now also be able to support liver cancer patients who may benefit from having a liver transplant.”
José Pereira Leal, Chief Executive Officer of Ophiomics, added: “Accurately identifying which HCC patients will benefit the most from a liver transplant enables better organ allocation and waiting lists management. Launching HepatoPredict through Biocartis’ network of European customers is a great next step in our collaboration to enable patients and healthcare providers to make the best treatment decisions.”
On 8 February 2022, Biocartis and Ophiomics (a Lisbon, Portugal-based biotech company developing a precision medicine portfolio focused on liver cancer) announced their partnership agreement. Under the terms of this agreement, Biocartis leads the commercialization of the manual HepatoPredict kit in Europe. Depending on the successful commercial uptake of the kit, Ophiomics and Biocartis aim to initiate the development of a fully automated version of the test on Biocartis’ decentralized Idylla™ platform.
Primary liver cancer is the sixth most common and third most lethal cancer in the world, with more than 900,000 new cases per year and resulting in more than 800,000 deaths per year (2). HCC is the most common type of primary liver cancer that frequently occurs in people with chronic liver diseases, such as cirrhosis (3). Liver transplantation is the best curative treatment for HCC patients. The current criteria used to identify patients for transplantation are either too strict (by rejecting patients that could benefit from the transplant) or overestimate the benefit from a liver transplantation (by selecting patients that will relapse afterwards).
HepatoPredict is a gene expression signature test that combines clinical parameters with molecular markers to assess the tumor biology, aiming to predict which patients will benefit most from a liver transplant and identifying those for which a transplant brings no benefit. HepatoPredict has been validated retrospectively with encouraging results, increasing the number of patients that can benefit from curative-intent transplantation by 31%4. The first clinical validation of HepatoPredict was published on 29 August 2022 in ‘Annals of Surgery’ in a collaborative retrospective study5 with Curry Cabral Hospital (Lisbon, Portugal). The study showed that HepatoPredict outperforms conventional selection criteria (6), as such providing superior information to identify patients that are most likely to benefit from a liver transplant.
More information on the test can be found on the Biocartis website here.
(1) Primary liver cancer is a cancer that starts in the liver, in contrast to secondary liver cancer where the liver tumoris the result of metastasis from a primary tumor elsewhere in the patient
(2) Source: Globocan 2020
(3) Cirrhosis is a late-stage liver disease that is characterized by fibrosis (scarring) of the liver tissue. Main causes include alcoholic liver disease (resulting from long-term alcohol overconsumption), non-alcoholic steatohepatitis (NASH; linked to obesity and type 2 diabetes) and chronic hepatitis B or hepatitis C infection
(4) Over Milan criteria, with a disease-free survival rate of 89%, or 94% when used in highest precision model. Source: Pinto-Marques H, Cardoso J, Silva S, Neto JL, Gonçalves-Reis M, Proença D, Mesquita M, Manso A, Carapeta S, Sobral M, Figueiredo A, Rodrigues C, Milheiro A, Carvalho A, Perdigoto R, Barroso E, Pereira-Leal JB. A Gene Expression Signature to Select Hepatocellular Carcinoma Patients for Liver Transplantation. Ann Surg. 2022 Aug 1. doi: 10.1097/SLA.0000000000005637. Epub ahead of print. PMID: 35916378. HepatoPredict improves current expanded selection models with precisions ranging between 53% and 84,5% while providing a clear, reproducible, objective prognosis in a few days. Source: Pavel M-C, Fuster J. Expansion of the hepatocellular carcinoma Milan criteria in liver transplantation: Future directions. WJG. 2018;24:3626–3636
(5) Pinto-Marques H, Cardoso J, Silva S, Neto JL, Gonçalves-Reis M, Proença D, Mesquita M, Manso A, Carapeta S, Sobral M, Figueiredo A, Rodrigues C, Milheiro A, Carvalho A, Perdigoto R, Barroso E, Pereira-Leal JB. A Gene Expression Signature to Select Hepatocellular Carcinoma Patients for Liver Transplantation. Ann Surg. 2022 Aug 1. doi: 10.1097/SLA.0000000000005637. Epub ahead of print. PMID: 35916378
(6) Such as Milan and UCSF. In order to identify a patient for liver transplant, different sets of criteria such as the Milan or the UCSF (University of California San Francisco) criteria are used