Biocartis Group NV has started the commercialization in Europe of the HepatoPredict test as a CE-IVD marked manual kit.
The test, developed by Portuguese biotech company Ophiomics, is a prognostic diagnostic test that supports the decision of liver transplantation in patients with hepatocellular carcinoma (HCC).
Herman Verrelst, chief executive officer of Biocartis, said: “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.”
Waiting list management
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.”
In February, Biocartis and Ophiomics announced their partnership agreement. Under the terms of the 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.
HCC is the most common type of primary liver cancer frequently occurring in people with chronic liver diseases, such as cirrhosis. 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 later relapse).
HepatoPredict is a gene expression signature test combining clinical parameters with molecular markers to assess the tumor biology. It aims 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%.
The first clinical validation of HepatoPredict was published in August in Annals of Surgery in a collaborative retrospective study with Curry Cabral Hospital (Lisbon, Portugal).
The study showed that HepatoPredict outperforms conventional selection criteria6, as such providing superior information to identify patients that are most likely to benefit from a liver transplant.