Ophiomics is a molecular diagnostics company based in Lisbon, Portugal that focuses on developing the next generation of products that will disrupt the way liver cancer is managed. Biocartis and Ophiomics announced their partnership agreement on February 8, 2022, which is focused on the commercialization of HepatoPredict (IVD), a prognostic gene expression signature test that can help identify which liver cancer patients will benefit from curative-intent surgery, in particular liver transplantation. HepatoPredict will be distributed by Biocartis in Europe as a manual kit mainly addressing centralized expert laboratories. The test may later be transformed into a version for use on the Biocartis Idylla™ Platform.
Liver cancer
Primary liver cancer1 is the sixth most common and third most lethal cancer in the world, with more than 900,000 new cases per year resulting in more than 800,000 deaths per year.2 Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer that frequently occurs in people with chronic liver diseases, such as cirrhosis.3 Treatment options include ablation4 , embolization5 , surgical resection6 or transplantation, with liver transplant being the most effective curative treatment for HCC patients with cirrhosis.7 Due to shortage of donor organs, the proper selection of patients is crucial. Current models to select patients are sub-optimal8 , leading to potential exclusion of patients that may benefit from surgery.
- 1Primary liver cancer is a cancer that starts in the liver, in contrast to secondary liver cancer where the liver tumors are the result of metastasis from a primary tumor elsewhere in the patient
- 2Globocan 2020
- 3Cirrhosis 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
- 4Ablation removes or destroys diseased tissue, for instance by temperature treatment
- 5Embolization is a procedure that injects substances directly into an artery in the liver to block or reduce the blood flow to a tumor in the liver
- 6In a partial hepatectomy the diseased section of the liver is removed. The remaining part of the liver may regrow, although with a reduced liver function
- 7Dhir M, Melin AA, Douaiher J, et al. A Review and Update of Treatment Options and Controversies in the Management of Hepatocellular Carcinoma. Annals of Surgery. 2016;263:1112–1125
- 8Currently used selection models rely on clinical morphological models (e.g. Milan criteria: Mazzaferro et al., N Engl J Med (1996) 334:693-700 or San Francisco criteria: Yao et al., Hepatology (2001) 33:1394-40)
HepatoPredict
HepatoPredict is a gene expression signature test that combines clinical parameters with molecular markers to assess the tumor biology, aiming at predicting which patients will benefit most from liver transplant and identifying those for which a transplant should be avoided. HepatoPredict has been validated retrospectively with encouraging results in predicting relapse-free transplantation. HepatoPredict can be used in two modes: in a maximum precision mode, that identifies about half of the good outcome patients, but with a 94% precision, thus significantly reducing the proportion of cancer recurrence; and in a high sensitivity mode, that identifies an additional 32% of patients over Milan criteria with a disease-free survival rate of ~89%, increasing the number of patients that can benefit from curative-intent transplantation and still decreasing the false positive assignments. 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. Further prospective1 and retrospective validation is ongoing.
The partnership will initially focus on the commercialization of the CE-marked IVD HepatoPredict manual kit in Europe. In a next stage, depending on successful commercial uptake of the manual kit, Ophiomics and Biocartis aim to initiate the development of a fully automated version of the test on Biocartis’ decentralized Idylla™ Platform.
- 1A cohort of 40 patients with hepatocellular carcinoma related to cirrhosis who are candidates for liver transplantation is being recruited at the Centro Hospitalar Universitário de Lisboa Central in Lisbon for prospective validation of HepatoPredict™. ClinicalTrials.gov identifier: NCT04499833
What our Partner says about the collaboration
Partnering with Biocartis moves us ever closer to the market through their outstanding commercial teams and network. It allows us to have an immediate impact in liver cancer patient care. On a more general note, this is a collaboration between two companies focusing on innovation in the precision medicine setting. For Ophiomics, it means access to know-how on deployment of diagnostics solutions in the real world, understanding of the characteristics and expectations of the end users, as well as a solid international presence.
José Pereira Leal, Chief Executive Officer of Ophiomics
