Eurobio Scientific and Acobiom announce the signature of an exclusive commercial agreement for the distribution of a diagnostic test that predicts response to a treatment for pancreatic cancer
CE marked test for patients with pancreatic ductal adenocarcinoma
Prediction of response to first-line gemcitabine-based chemotherapy
Developed and validated with real world data and samples
Paris & Montpellier, November 22, 2022 - 5h45 pm
Eurobio Scientific (Euronext Growth Paris, FR0013240934, ALERS), French leader group in medical diagnosis and life sciences, and Acobiom, a French company expert in the identification of biomarkers and the development molecular diagnostics for precision medicine, announce the signature of an exclusive commercial agreement for the distribution, in France, Germany and the United Kingdom, of GemciTest®, a CE marked test for the predictive diagnostics of response to gemcitabine-based chemotherapy in pancreatic cancer.
A tough cancer without prior assessment of potential treatment efficacy
Pancreatic cancer is an aggressive cancer. According to the International Agency for Research on Cancer (WHO, Globocan data), the incidence of this cancer was about 202,000 new cases in 2020 in Europe and North America, increasing by 2.5% per year on average. In France, this cancer affected about 15,000 patients in 2020, of which nearly 45% would be at the metastatic stage. Diagnosis is generally made by imaging and biological tests on biopsy.
Pancreatic cancer is particularly insidious because it is a "silent" disease that causes no symptoms in its early stages. Often diagnosed at a late stage, this cancer has a poor prognosis. Few treatments are available: surgery and/or chemotherapy. For patients with locally advanced or metastatic cancer at the time of diagnosis, chemotherapy remains the only treatment option, whether it is based on gemcitabine or 5-FU, alone or in combination.
GemciTest®, an in-vitro diagnostic developed by Acobiom, is a predictive PCR test for response to gemcitabine-based chemotherapy in first-line treatment. This CE-marked molecular diagnostic identifies patients with pancreatic ductal adenocarcinoma (PDAC, a form of pancreatic cancer) whose transcriptomic profile is not favorable for the prescription of a first-line gemcitabine-based therapy (alone or in combination). This test will thus make it possible to guide patients towards another more suitable or more effective therapy, to avoid unnecessary side effects or toxicities, and thus to risk a "loss of chance" for these patients.
A new test based on the latest technologies
GemciTest has been developed with Acobiom's technology platform, which combines genomic and transcriptomic techniques (NGS sequencing, real-time PCR) with bioinformatics, biostatistics and artificial intelligence (machine learning) tools and programs for data processing and analysis.
Developed and validated using real-world data and samples, this molecular diagnostics is based on a proprietary combination of RNA markers present in blood. The test was evaluated in a confirmatory study to measure its sensitivity in predicting the response of PDAC patients to a gemcitabine-based chemotherapy in first-line treatment.
This confirmatory study demonstrated the value of using GemciTest® in clinics and also reveals the potential of RNA marker combinations in blood in the development of precision medicine and personalized therapy for patients with pancreatic cancer.
“The signature of this commercial agreement with Eurobio Scientific is the recognition of the quality of the developments made by the Acobiom team by a key-player of the in-vitro diagnostic industry in France", says Didier Ritter, President of Acobiom. "It is also a first step for our company, as other predictive diagnostics in precision medicine are currently in development, notably to predict the response to 5-FU-based chemotherapy in first-line treatment of pancreatic cancer.”
Jean-Michel Carle, CEO of Eurobio Scientific, added: "The importance of a predictive response test for a disease as difficult as pancreatic cancer will be a major asset for physicians by allowing their patients to avoid losing chances due to inappropriate treatments. The strength of the new technologies used and the quality of the work done by Acobiom, as demonstrated by the results of their real-world clinical tests, have convinced us of the immediate relevance of this new test".
GemciTest® is a predictive molecular diagnostic for response to gemcitabine-based chemotherapy in first-line treatment. This CE-marked PCR test is intended for patients with pancreatic ductal adenocarcinoma (PDAC). This in-vitro diagnostic has been developed from Acobiom's technology platform, which combines genomic and transcriptomic techniques (NGS sequencing, real-time PCR) on the one hand, and bioinformatics, biostatistics and machine learning tools and programs for data processing and analysis on the other.
Developed and validated using real world data and samples, GemciTest® is based on a patented combination of RNA markers present in blood and has been evaluated in a confirmatory study. The clinical validation of this PCR test was performed on 336 patients (mean age 68.7; 37-88). Patients with a clinical benefit (OS > 8.7 months; PFS ≥3.5 months) identified by GemciTest® (29.7%) had significantly a longer PFS (5.3 vs. 2.8 months) and a longer OS (10.4 vs. 4.8 months). GemciTest® -positive patients had significantly longer PFS (HR=0.53 (95% CI: 0.31-0.92); p=0.023) and OS (HR=0.49 (95% CI: 0.29-0.85); p=0.0091).
About Eurobio Scientific
Eurobio Scientific is a major player in the field of specialty in vitro diagnostics. It is active in the research and marketing of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and provides dedicated reagents to research laboratories, including pharmaceutical and biotechnology companies. With its numerous partnerships and strong hospital presence, Eurobio Scientific has its own extensive distribution network and a portfolio of proprietary molecular biology products. The Group has approximately 250 employees, four manufacturing facilities based in the Paris area, Germany, the Netherlands and the USA, and subsidiaries in Dorking in the UK, Sissach in Switzerland, Bünde in Germany and Utrecht in the Netherlands.
For more information, please visit the website: www.eurobio-scientific.com
Eurobio Scientific shares are listed on Euronext Growth Paris.
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Mnémonics: ALERS - ISIN Code: FR0013240934 - Reuters: ALERS.PA - Bloomberg: ALERS:FP
Acobiom is a biotechnology company specializing in the discovery of biological markers (biomarkers) and the development of innovative molecular diagnostics for applications in personalized medicine or precision medicine. Precision medicine aims at personalizing treatments according to certain biomarkers in order to obtain a better therapeutic effectiveness, to limit the side effects of a treatment and to ensure a better quality of life for the patient. The diagnostics developed by ACOBIOM respond to these needs and support medical teams in choosing the most effective treatment best suited to the transcriptomic profile of each patient. These diagnostics are developed from biomarkers, identified by the company's scientific team, which has more than 20 years of expertise in the study of gene expression and a technological platform combining genomics, transcriptomics, bioinformatics, biostatistics (data science) and machine learning (artificial intelligence). Founded in 1999, Acobiom is located in the Euromedicine Biopole in Montpellier (France), and is a member of the regional health clusters.
For more information: www.acobiom.com
Media and investor Contacts
Eurobio Scientific Calyptus
Jean-Michel Carle, CEO Mathieu Calleux / Maisie Mouret
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