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hPG80 Performances A performing biomarker. Present at all stages and for Multiple Cancer Types. 1 Healthy Blood Donors vs All Combined Cancers Significant increase in hPG 80 levels in all cancer patients (N= 1267, Median hPG 80 = 4.77 pM) compared to healthy blood donors (N=557 for 18-70 yo, Median hPG 80 = 1.05 pM and N=137 for 18-25 yo, Median hPG 80 = 0.2 pM). You B, Mercier F, Assenat E, et al : The oncogenic and druggable hPG80 is overexpressed in multiple cancers and detected in the blood of patients. EBioMedicine 51:102574, 2020 1. Healthy Blood Donors vs All Combined Cancers 2 Diagnostic des performances de hPG80 par types de tumeurs Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. 2. Diagnostic performances of hPG80 per Tumor types 3 Performances of hPG80 vs Existing Tumor Markers BREAST CANCER Diagnostic efficacy of CA 15-3 and CEA in the early detection of metastatic breast cancer – A retrospective analysis of kinetics on 743 breast cancer patients. Stieber P et al., Clin Chim Acta., 2015. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard,Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. N=53 patients. N=9 patients, work ongoing. COLORECTAL CANCER CEA Monitoring in Colorectal Cancer. Fakih MG, Padmanabhan A., Oncology (Williston Park), 2006. Cutoff at 5 ng/mL. Direct Comparison of Diagnostic Performance of 9 Quantitative Fecal Immunochemical Tests for Colorectal Cancer Screening. Gies A et al., Gastroenterology, 2018. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. N = 98 patients. N = 192 patients. HEPATOCELLULAR CARCINOMA Serum tumor markers for detection of hepatocellular carcinoma. Zhou L et al., World J Gastroenterol., 2006. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. N = 27 patients. N = 65 patients. hPG 80 has a better sensitivity to detect HCC than AFP. AFP was above 20ng/ml in 54.3% of the samples while hPG 80 (circulating progastrin) was detected in 80.2% (threshold = 1pM). ​ Progastrin a new biomarker for hepatocellular cancer patient follow-up. Alexandre Prieur, Marie Dupuy, Pierre Liaud, Dominique Joubert and Eric Assenat. AACR 2019 - Poster #2222. OVARIAN CANCER Clinical analysis of four serum tumor markers in 458 patients with ovarian tumors: diagnostic value of the combined use of HE4, CA125, CA19-9, and CEA in ovarian tumors. Chen F et al., Cancer Manag Res, 2018. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. N = 27 patients. N = 181 patients. PROSTATE CANCER A review on the clinical Utility of PSA in Cancer Prostate. Adhyam M, Gupta AK; Indian J Surg Oncol, 2012. PSA cutoff at 4 ng/mL. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, VéroniqueSaywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. N = 93 patients. N = 444 patients. 3. Performances of hPG80 vs Existing Tumor Markers 4. hPG80 for the monitoring of Minimal Residual Disease and Response to Treatment 4 hPG80 for the monitoring of Minimal Residual Disease and Response to Treatment PERITONEAL CARCINOMATOSIS A cohort of patients with peritoneal involvements from gastrointestinal cancers, treated with peri-operative chemotherapy regimens and cytoreductive surgery (Lyon, France, NCT02823860). Global analysis. High levels of hPG80 before surgery. Decrease of hPG80 8h to 24h after surgery (From 3.08 pM to 1.57 pM; p=0.035). Individual analysis. 74.2% of the patients had a decrease of at least 25% of hPG80 levels after surgery. Sustained elevations in hPG80 concentrations after surgery could be suggestive of the presence of residual disease. You B, Mercier F, Assenat E, et al : The oncogenic and druggable hPG 80 is overexpressed in multiple cancers and detected in the blood of patients. EBioMedicine 51:102574, 2020 Gilles Freyer, Delphine Maucort-Boulch, Dominique Joubert and Olivier Glehen. ESMO 2018 - Poster # 1953. PROSTATE CANCER Elevated hPG80 levels in patients with advanced prostate cancer (aPCa)* (healthy blood donors 18 to 40 yo: median hPG80 = 0.37 pM vs aPCa: median hPG80 = 4.7 pM, p<0.0001). *aPCa includes metastatic hormone sensitive (mHSPC) and metastatic castration resistant (mCRPC) prostate cancer patients. Overall survival (OS) according to hPG80 levels evolution during follow-up. Patients with a serial increase of hPG80 had a worst overall survival compare to the other group (9.3 yo vs 12.4 yo, P = 0.019). Plasma Progastrin Level As A Prognostic Biomarker In Advanced Prostate Cancer. Manish Kohli, Winston Tan, Léa Payen, Carole Langlois-Jacques, Pierre Liaud, Delphine Maucort-Boulch, Dominique Joubert and Alexandre Prieur. AACR 2019 - Poster #2294. KIDNEY CANCER Elevated hPG80 levels in patients with metastatic renal cell carcinoma (mRCC) (Cohort (healthy blood donors18-25 y/o): median hPG80 = 0.29 pM vs mRCC hPG80= 7.2 pM). We compared hPG80 levels with the MSKCC prognostic criteria for patient survival. In this score, patients are separated in 3 groups: good, intermediate and poor prognostic. hPG80 levels were higher within the MSKCC score poor prognostic group (p<0.001) (median 30.39 pM vs 6 pM and 9.34 pM in the good and intermediate group, respectively). hPG80 assay might be useful for defining subsets of mRCC patients with poor survival who need to be treated aggressively. Prognostic Impact Of Progastrin Levels In Blood Compared To MSKCC Based Clinical Prognosis In Metastatic Renal Cell Cancer Patients. Manish Kohli, Winston Tan, Léa Payen, Carole Langlois-Jacques, Pierre Liaud, Delphine Maucort-Boulch, Dominique Joubert and Alexandre Prieur. AACR 2019 - Poster #2289. 5 hPG80 for the Monitoring of Relapse (Tumor Activity) MONITORING FOR HEPATOCELLULAR CARCINOMA RECURRENCE Earlier detection of small lesions and the monitoring of recurrence may be improved with hPG80 as a supplemental blood-based biomarker, especially in AFP negative populations where there is limited information. Patients in remission following disease management have lower hPG80 concentrations compared to active cancers. 76% of patients with progressing disease during or after treatment had an increased hPG80 > 25%. Illustrative hPG80 longitudinal changes around and during disease management (baseline; remission; progression), with associated imaging obtained at the same times in a typical patient. Progastrin a new biomarker for hepatocellular cancer patient follow-up. Alexandre Prieur, Marie Dupuy, Pierre Liaud, Dominique Joubert and Eric Assenat. AACR 2019 - Poster # 2222. You B, Mercier F, Assenat E, et al : The oncogenic and druggable hPG80 is overexpressed in multiple cancers and detected in the blood of patients. EBioMedicine 51:102574, 2020. MONITORING FOR OVARIAN CANCER RECURRENCE 70% of ovarian cancers are not diagnosed until stage III or IV where survival rates are low (48% after 5 years). As a result, cancer recurrence is high (70-95%) following standard treatment by surgery and combination chemotherapy. hPG80, as a blood-based biomarker used in conjunction with CA125, could improve the early detection of residual disease, treatment efficacy, and/or relapse following treatment. Progastrin, a Novel Ubiquitous Cancer Blood Biomarker for Early Detection and Monitoring. Benoit You, Eric Assenat, Olivier Glehen, Delphine Maucort-Boulch, Léa Payen, Vahan Kepenekian, Marie Dupuy, Pierre Liaud, Thibault Mazard, Gwenaël Ferron, Maud Flacelière, Julien Soulé, Véronique Saywell, Fanny Belouin, Winston Tan, Laurent Villeneuve, Marc Ychou, Manish Kohli, Dominique Joubert and Alexandre Prieur. ASCO 2019 - Poster #3037. Learn more... about hPG80 Main Scientific Publications

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Nouveau titre Contract signed with: Montpellier Cancer Institute, France ​ Principal investigator: Marc Ychou Liquid biopsy will become the new standard for diagnosing tumors and monitoring treatments (Bardelli et al, Cancer Cell, 2017). Plasma hPG80 detection assay falls within this framework. ECS-Progastrin has developed a sandwich ELISA assay, which is reliable, simple, robust, inexpensive and used in almost all laboratories and hospitals around the world. ​ Using our ELISA assay, we have already demonstrated the presence of hPG80 on a first cohort of colorectal cancer patients, mainly patients in late stages (more than 150 patients in stage 3 and 4) and some early stages (20 patients in stage 1 and 2). Whatever the stage, hPG80 is detected with very good sensitivity. Similarly, we showed the presence of hPG80 in the blood of 58 patients with adenomatous polyps, with very good sensitivity. With regard to hyperplastic polyps, we were only able to analyze the presence of hPG80 in a limited number of cases (n = 10). hPG80 was not detected in any of these patients. ​ This project aims to increase the number of patients with stage I and II colorectal cancer or with hyperplastic or adenomatous polyps, for whom we will measure plasma hPG80 levels. This will clarify the value of hPG80 as a biomarker for patients with early stages colorectal cancer and for patients with polyps. Non Pathologic Condition hPG80 is not found in the blood of healthy people. When progastrin is maturated into gastrin, it is released from the cells. ​ When gastrin is produced by the G cells of the stomach antrum, it plays its role to control acidic secretions during digestion. Pathologic Condition hPG80 is detected in the blood of cancer patients. When progastrin is not maturated into gastrin, it is released from the cells as such and named hPG80. ​ This only happens in tumor cells, whatever the tumor cell: progastrin becomes a circulating protein, hPG80, which can be detected in the blood of cancer patients. Show the presence or absence of hPG80 in the blood of patients with adenomatous polyps or with early colorectal cancer and establish the discriminative accuracy of hPG80 as a biomarker of these pathologies. ​ Correlate hPG80 levels with cancer stage. Cancer patients samples were obtained from SIRIC (Montpellier, FRANCE). Analyzes were performed within Eurobiodev facility (Montpellier, FRANCE). This retrospective study was approved by Montpellier cancer institute scientific council (ICM-CORT). Approval date and number: 13/11/2017 (ICM-CORT-2017-23) 96 patients were included in the study. Healthy blood donors samples were obtained from the French blood agency (EFS, Montpellier, FRANCE). Analyzes were performed within Eurobiodev facility (Montpellier, FRANCE). Approval date and number: 17/07/2017 (21PLER2017-0019) 80 non-fasting healthy donors were included in the study. The presence of hPG80 in early colorectal cancer stages was confirmed. ​ Median hPG80 levels in CRC early stages patients were significantly higher than those in healthy blood donors (p< 0.0001) (Figure 1). Median hPG80 concentration was 0.23 pM (IQR 0.00-0.80 pM) in control population, against 2.315 pM (IQR 0.64-3.69 pM), 2.26 pM (IQR 0.70-9.60 pM), and 5.46 pM (IQR 1.67-9.945 pM) in patients with preneoplasic lesions, CRC stage 1 or CRC stage 2, respectively (Figure 1). There is a significant increase in hPG80 blood levels from adenomatous polyps to stage 2 colorectal cancer. Figure 1. Comparison of hPG80 concentrations between healthy blood donors (n=80) and cancers patients, preneoplasic lesions (n=24), stage 1 CRC (n=23), stage 2 CRC (n=49). Representation in box and Whiskers (2.5-97.5 percentile, dots are outliers). Two-tailed Mann-Whitney test; ***, p< 0.001; *, p< 0.05. The diagnostic discriminative accuracy of hPG80 levels was estimated using Receiver Operating Characteristics (ROC) curves in patients with preneoplasic lesions, patients with stage 1 CRC or patients with stage 2 CRC, compared to healthy blood donors control cohort. ​ The diagnostic discriminative accuracy estimated by the ROC AUC were 0.80 (95% CI: 0.69 to 0.91) for patients with preneoplasic lesions; 0.825 (95% CI: 0.72 to 0.93) for patients with stage 1 CRC; and 0.89 (95% CI: 0.82 to 0.95) for patients with stage 2 CRC, compared to the blood donor control group (Figures 2, 3 and 4). 1 Scientific context 2 hPG80, a new blood based biomarker 3 Objectives 4 Patients 5 Results 6 Conclusion hPG80 is detected with a very good accuracy in the blood of patients with an adenomatous polyp or with a stage 1 or 2 colorectal cancer.

About Us Our Mission In the battle against cancer, BIODENA CARE considers its mission as a succession of relays between Fundamental Scientific Knowledge on the one hand and "the Art and Science of Medicine" on the other. The final relay, undoubtedly the most important, is the one that the Physician must carry out alone with his Patient, against the disease. This is why, in order to never forget the Patient, we carry out our mission by exclusively serving Physicians with a single objective: « To ensure that demonstrations of basic science become effective, reliable and accessible solutions, handed over to physicians for the benefit of their patients. » Executive Team Nassima Mimoun Managing Director Skills Medical Doctor MBA from an international Business school in Paris ESCP Business School Harvard Business School: Executive Leadership Program Professional strength 25 years of experience in Pharma Industry Broad range of experiences across various therapeutic areas at regional and local level in multiple markets and mainly in oncology Solid experience in launching and successfully commercializing innovative products and identifying life cycle management opportunities Ability to work successfully with external stakeholders by integrating their insights Strong learning agility and a good track record in coming into new and challenging situations in both, strategic and operational roles using strong communication and interpersonal skills Diversity & Inclusion as a DNA to build right teams and talents working cross functionally Acting & leading by example. Supporting and driving transformations with flexibility and adaptability. Alexandre Prieur Chief Scientific Officer Skills Scientific Director since 2012 20 years in cancer research 8 years of R&D specific to hPG80 (extra-cellular circulating progastrin) PhD in Oncology since 2005 (Paris XI University) Master - Innovation, Valorization, Partnerships (Montpellier University) in 2013 Professional strength 12 years of fundamental research as a researcher in cancer research institutes in Europe 8 years of R&D in biotechnology companies as Chief Scientific Officer (diagnostic and therapy) ​ Results​ Listed as inventor for 8 patent applications, including 7 on interaction between hPG80 and cancer Author of 10+ publications in peer-reviewed journals in the field of cancer Co-editor at Frontiers in Oncology on the Research Topic “Therapeutic Targeting of Cancer Stem Cells- The Current State of the Art “ in 2019 ​ François Fabre Chief Financial and Operationnal Officer Skills Administrator of the group entities Fundraising lead Specialist in business management Master's degree in international business ​ Professional strength 8 years as managing director or general manager of companies 5 years in cash and investment management ​ Results Fundraising actions up to 26 M € Drastic cost management to ensure the sustainability of this company Monica Cappellini Laboratory Manager Skills 7 years of experience in R&D and production specific to hPG80 PhD in Neuroscience (University of Montpellier) ​ Professional strength 19 years of experience in start-up companies as in vivo and/or laboratory manager. Strong team management and project management Implementation and maintenance of quality system according to ISO 13485 ​ Results Co-author in several articles related to hPG80 Successful launch of the DxPG80 kit ​ Christel Massonnat Director of Customer Service and Logistics Skills 20+ years of expertise in logistics operations and customer service. Triple sensitivity: industry, business and international. Successful track record in unit management. Strong managerial, negotiation and project management skills. Professional strength in health and logistics industries within large international groups and also in smaller companies in certified quality, safety and environment settings where continuous improvement is a permanent objective. in different functions with responsibilities, on all the value chain of the company from purchasing to delivery and from service to customers. Objective To put my experience in industrial pharma at the service of public health worldwide. ​ Our History Our History The dream of a scientist, the fight of a woman Dominique Joubert is a scientist with a PhD in biology, coming from academic and fundamental research in which she worked for more than 40 years, including two decades from 1991 to 2011 as Director of Research at Inserm (France) and Director of the Oncology Department of the IGF, a CNRS-INSERM-University of Montpellier Joint Research Unit. ​ Contrary to scientific dogma, she has always been convinced that cancer responds to the "laws of the living" and is therefore reversible. She is therefore naturally looking for the "key" to this reversion. ​ In 2003, in her laboratory, her team and herself observed a protein that needs to come out of the tumor cell and re-interact with it to exert its effects on the tumor cell. ​ She believes that this protein, resulting from a set of disorders linked to the Wnt signaling pathway (highly involved in tumorigenesis), may be the key she is looking for. ​ She is modeling an experiment to demonstrate that neutralizing this protein can regulate the pathway that generated it. This approach seemed absurd to her team. Neutralizing the product of a mechanism to regulate the said mechanism, the idea is far-fetched! ​ To the surprise of sceptics, the experiment is conclusive, demonstrating for the first time that the tumor mechanism can be reverted into a solid tumor. ​ In a healthy individual, this protein, progastrin, is the precursor of gastrin, it is present in the G cells of the stomach, it is not found in the blood. In a patient with cancer (any cancer to date), it is secreted by the tumor cell of the organ affected by this cancer, it is then called hPG80. We’ve so far detected hPG80 in the blood of 83% cancer patients. Moreover, 100% of tumors produce hPG80[1]. ​ Dominique Joubert now knows that what has just been proven will simply change the history of cancer! She also knows that there is another equally challenging round ahead: bringing together all the energy, resources and expertise needed to ensure that a demonstration of basic research is translated into solutions for physicians, for the benefit of patients. ​ [1]. You et al, EBioMedicine, 2020 Jan;51:102574

Last Update : Feb 02, 2020 News: Events Dec 17, 2021 2 min hPG80 at ASCO 2021 - Prolevcan study Plasma hPG80 circulating prograstin levels in cancer patients in Nigeria: Prolevcan study Dec 17, 2021 3 min hPG80 at ASCO 2021 - Hepatocellular carcinoma ASCO Poster Session: Prognostic value of plasma hPG80, alone or in combination with AFP, in patients with hepatocellular carcinoma Dec 17, 2021 2 min A Major Publication: The Overexpression of hPG80 (circulating progastrin) in Multiple Cancers The oncogenic and druggable hPG80 (Progastrin) is overexpressed in multiple cancers and detected in the blood of patients Dec 17, 2021 1 min Dr. Aman Chauhan MD (Markey Cancer Center) speaking about hPG80 at #GI ASCO 2020 HPG80 (Progastrin), a novel blood-based biomarker for detection of neuroendocrine neoplasms. GI ASCO / Presented Friday, January 24, 2020

​ DxPG80 IVD ELISA Human circulating Progastrin (hPG80) Immunoassay​ The DxPG80 test is an ELISA (Enzyme-Linked Immunosorbent Assay) for the detection of hPG80 (circulating human progastrin). The test is intended for professional laboratory use only. ​ Please note that for greater clarity, we use the name hPG80, referring to extracellular Progastrin. The test is based on the principle of a sandwich ELISA to measure the concentration of hPG80 in plasma samples that have been collected in EDTA tubes. Briefly, a capture antibody specific for hPG80 is immobilised on the 96-well plate. The hPG80 present in the calibrators and samples added to the wells will bind to the immobilized capture antibody. The test plate includes calibrators which are used to estimate the level of hPG80 in EDTA plasma samples. The wells are washed and an anti-hPG80 detection antibody coupled to horseradish peroxidase (HRP) is added, resulting in an antibody-antigen-antibody complex. After a second wash, a substrate solution of 3,3',5,5'-Tetramethylbenzidine (TMB) is added to the wells, producing a blue colour directly proportional to the amount of hPG80 present in the initial sample. The Stop Solution changes the colour from blue to yellow, and the wells are read at 450 nm with a microplate reader. The assay is technically characterised in manual mode by a limit of detection (LoD, 1.0 pM) and a limit of quantification (LoQ, 3.3 pM). The LoD detects the presence of hPG80 and the LoQ gives the concentration at which the assay is quantitative. ​ Table 1 : Comparative description of hPG80 in Controls (healthy blood donors 18-40 years old at low risk of cancer) and Cancer patients (16 cancers tested, all combined)[1]. Reference range are given for a 2.5 (low range) and 97.5 (high range) percentile. IQR: Inter-Quartil Range, 25-75%. SE: Standard Error. BIBLIOGRAPHY [1]. You et al, EBioMedicine, 2020 Jan;51:102574 From the blood test to reporting the result to the physician:

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Download Our job is only to produce and market innovative tools for physicians. They then identify and define the best way to use our tools. For this reason, we invite you to follow this link to visit the "Physician & Patient Support" page of the Progastrin Cancer Control Association 's website, an association of healthcare professionals that collects, enhances and diffuses knowledge about hPG80 and its usefulness in the fight against cancer. ​ Documents presently available : White paper on the link between hPG 80 (circulating Progastrin) and cancer Physicians' booklet Leaflet for doctors to give to their patients General and pathological data sheets

Biodena Care optimizes cancer management A simple and accessible test In 2003, our R&D team discovered the essential role of the hPG80 protein in cancer progression. From this discovery, which came from French research, we developed a practical and affordable blood test: DxPG80. DxPG80: a new device to lead the fight against cancer Through a simple blood test, the DxPG80 test reveals the presence of hPG80, a biomarker specifically associated with cancer diagnosis. See more French research excellence at the service of patients Proposing a more efficient support The reliable and reproducible DxPG80 test contributes to the optimization of the oncology patient journey. The incidence of cancer is growing inexorably, it is time to act practically 19.3 million 28.4 million 200 billion € new cases in 2020 new cases forecasted in 2040 EU and US treatment cost in 2017 Cancer: earlier detection, greater chance of remission Sources : WHO and Cancer Atlas Our ambition: innovation at the service of the patient Tomorrow, we will become a key player in the overall management of cancer patients in termes of: Early diagnosis Localization Therapeutic strategy for patients with a first-in-class therapeutic antibody. Contact us

Quantification of hPG80 in the blood of patients with adenomatous and hyperplastic polyps and early stage colorectal cancer Contract signed with: Montpellier Cancer Institute, France ​ Principal investigator: Marc Ychou Liquid biopsy will become the new standard for diagnosing tumors and monitoring treatments (Bardelli et al, Cancer Cell, 2017). Plasma hPG80 detection assay falls within this framework. ECS-Progastrin has developed a sandwich ELISA assay, which is reliable, simple, robust, inexpensive and used in almost all laboratories and hospitals around the world. ​ Using our ELISA assay, we have already demonstrated the presence of hPG80 on a first cohort of colorectal cancer patients, mainly patients in late stages (more than 150 patients in stage 3 and 4) and some early stages (20 patients in stage 1 and 2). Whatever the stage, hPG80 is detected with very good sensitivity. Similarly, we showed the presence of hPG80 in the blood of 58 patients with adenomatous polyps, with very good sensitivity. With regard to hyperplastic polyps, we were only able to analyze the presence of hPG80 in a limited number of cases (n = 10). hPG80 was not detected in any of these patients. ​ This project aims to increase the number of patients with stage I and II colorectal cancer or with hyperplastic or adenomatous polyps, for whom we will measure plasma hPG80 levels. This will clarify the value of hPG80 as a biomarker for patients with early stages colorectal cancer and for patients with polyps. Non Pathologic Condition hPG80 is not found in the blood of healthy people. When progastrin is maturated into gastrin, it is released from the cells. ​ When gastrin is produced by the G cells of the stomach antrum, it plays its role to control acidic secretions during digestion. Pathologic Condition hPG80 is detected in the blood of cancer patients. When progastrin is not maturated into gastrin, it is released from the cells as such and named hPG80. ​ This only happens in tumor cells, whatever the tumor cell: progastrin becomes a circulating protein, hPG80, which can be detected in the blood of cancer patients. Show the presence or absence of hPG80 in the blood of patients with adenomatous polyps or with early colorectal cancer and establish the discriminative accuracy of hPG80 as a biomarker of these pathologies. ​ Correlate hPG80 levels with cancer stage. Cancer patients samples were obtained from SIRIC (Montpellier, FRANCE). Analyzes were performed within Eurobiodev facility (Montpellier, FRANCE). This retrospective study was approved by Montpellier cancer institute scientific council (ICM-CORT). Approval date and number: 13/11/2017 (ICM-CORT-2017-23) 96 patients were included in the study. Healthy blood donors samples were obtained from the French blood agency (EFS, Montpellier, FRANCE). Analyzes were performed within Eurobiodev facility (Montpellier, FRANCE). Approval date and number: 17/07/2017 (21PLER2017-0019) 80 non-fasting healthy donors were included in the study. The presence of hPG80 in early colorectal cancer stages was confirmed. ​ Median hPG80 levels in CRC early stages patients were significantly higher than those in healthy blood donors (p< 0.0001) (Figure 1). Median hPG80 concentration was 0.23 pM (IQR 0.00-0.80 pM) in control population, against 2.315 pM (IQR 0.64-3.69 pM), 2.26 pM (IQR 0.70-9.60 pM), and 5.46 pM (IQR 1.67-9.945 pM) in patients with preneoplasic lesions, CRC stage 1 or CRC stage 2, respectively (Figure 1). There is a significant increase in hPG80 blood levels from adenomatous polyps to stage 2 colorectal cancer. Figure 1. Comparison of hPG80 concentrations between healthy blood donors (n=80) and cancers patients, preneoplasic lesions (n=24), stage 1 CRC (n=23), stage 2 CRC (n=49). Representation in box and Whiskers (2.5-97.5 percentile, dots are outliers). Two-tailed Mann-Whitney test; ***, p< 0.001; *, p< 0.05. The diagnostic discriminative accuracy of hPG80 levels was estimated using Receiver Operating Characteristics (ROC) curves in patients with preneoplasic lesions, patients with stage 1 CRC or patients with stage 2 CRC, compared to healthy blood donors control cohort. ​ The diagnostic discriminative accuracy estimated by the ROC AUC were 0.80 (95% CI: 0.69 to 0.91) for patients with preneoplasic lesions; 0.825 (95% CI: 0.72 to 0.93) for patients with stage 1 CRC; and 0.89 (95% CI: 0.82 to 0.95) for patients with stage 2 CRC, compared to the blood donor control group (Figures 2, 3 and 4). 1 Scientific context 2 hPG80, a new blood based biomarker 3 Objectives 4 Patients 5 Results 6 Conclusion hPG80 is detected with a very good accuracy in the blood of patients with an adenomatous polyp or with a stage 1 or 2 colorectal cancer.