Biocartis launches the European marketing of a test for liver cancer

Biocartis Group NV has started marketing in Southern Europe HepatoPredict test in the form of a CE-IVD marked manual kit.

The test, developed by Portuguese biotech company Ophiomics, is a prognostic diagnostic test that supports the decision for liver transplantation in patients with hepatocellular carcinoma (HCC).

Herman Verrelst, CEO of Biocartis, said: “We are very pleased to launch the commercialization of HepatoPredict in Europe. Thanks to our well-established European base of customer laboratories, in collaboration with Ophiomics, we will now also be able to support patients with liver cancer who could benefit from a liver transplant.

Management of waiting lists

José Pereira Leal, CEO of Ophiomics, added, “Accurate identification of HCC patients who will benefit most from a liver transplant enables better organ allocation and better management of waiting lists. The launch of HepatoPredict through Biocartis’ European customer network 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 is leading the commercialization of the HepatoPredict manual kit in Europe. Depending on the successful commercial adoption of the kit, Ophiomics and Biocartis aim to initiate development of a fully automated version of the test on Biocartis’ decentralized Idylla platform.

Liver cancer

Primary liver cancer is the sixth most common cancer and the third deadliest 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 occurring frequently in people with chronic liver diseases, such as cirrhosis. Liver transplantation is the best curative treatment for patients with HCC. Current criteria for identifying transplant patients are either too strict (by rejecting patients likely to benefit from transplantation) or overestimating the benefit of liver transplantation (by selecting patients who will later relapse).

HepatoPredict is a gene expression signature test combining clinical parameters with molecular markers to assess tumor biology. It aims to predict which patients will benefit the most from a liver transplant and to identify those for whom a transplant does not bring any benefit. HepatoPredict has been validated retrospectively with encouraging results, increasing by 31% the number of patients who can benefit from a transplant with curative intent.

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, providing superior information to identify patients most likely to benefit from liver transplantation.

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