PRODUCTS DO A TEST INNOVATION COMPANY Client Access About BioPredictive As is often the case with major scientific discoveries, our inventions are a conscious blend of vision, perseverance, patience, and chance. The history of FibroTest and BioPredictive are no exception. 2019 : Launch of NASH-FibroTest NASH-FibroTest is offered as a replacement for FibroMax and is available in exactly the same way on our platform. NASH-FibroTest is comprised of FibroTest, ActiTest, AshTest and a new generation of diagnostic tests: NashTest 2 1 and SteatoTest 2 2 . NASH-FibroTest is indicated for patients with non alcoholic steato hepatitis but also for patients with chronic viral hepatitis and/or a alcoholic disease. NASH-FibroTest Medical Service Improvements: Based on a new histological consensus 3 , updated from the new NASH definition and meeting the requirements of the new SAF scoring system 4 . Does not require knowledge of the body mass index (BMI). The use of the BMI is limited by its variability due to self-reporting and the decrease in height with age. Collecting the weight and height may be an issue for the stakeholders. More robust in patients with type 2 diabetes. More robust in patients with hemolysis or Gilbert's syndrome. 2013 : First test to be combined with elastography Elasto-FibroTest 5 is the first diagnostic test for the liver that combines the results of the FibroTest-ActiTest with an elastography result, directly from your smartphone. 2011 : First test to be combined with genetic analysis Launch of the HCV-GenoFibroTest 6 , which anticipates the response to interferon treatments for hepatitis C; in particular in combination with FibroTest and genotype IL28b. 2005 : Launch of FibroMax FibroMax offers a complete diagnosis of the state of the liver with a single blood test: FibroTest: evaluates hepatic fibrosis and cirrhosis ActiTest: evaluates the level of necroinflammatory activity. SteatoTest 7 : steatosis (fatty liver deposit) assessment NashTest 8 : evaluates non-alcoholic steatohepatitis (inflammation of the liver due to metabolic causes) AshTest 9 : evaluates alcoholic steatohepatitis (inflammation of the liver due to alcohol) 2003 : Launch in the USA FibroTest becomes available in the United States, distributed by LabCorp, under the FibroSure brand. A few years later, BioPredictive tests were distributed by the major North American laboratories. 2002 : The history of BioPredictive Founding of BioPredictive, head of R&D, business development and distribution of FibroTest-ActiTest 2001 : Invention of FibroTest FibroTest 10 developed by the Hepatology Department team at La Pitié-Salpêtrière University Hospital, Paris, France. The first combination of blood markers that replaces liver biopsies when testing for hepatic fibrosis. Patents held by the Assistance Publique des Hôpitaux de Paris (APHP). 1996 : METAVIR METAVIR 11 classification, which separates fibrosis and activity in the histological evaluation (the biopsy) of the seriousness of the liver disease. 1994 : PGA Index The first test 12 for hepatic fibrosis combining the usual blood markers. Our values Patients come first Patients are at the heart of BioPredictive's concerns, and they are systematically taken into account throughout our work and our approach. In 2002, we modernized the traditional results sheet to make it a reference document that would open up a genuine dialogue between patients and their physicians. We aim to offer new tools, both to support users more effectively and to assist patients in the interpretation of their results. Innovation Innovation is part of BioPredictive's DNA. This has been part of the company's routine since 2002: With the medical revolution brought about by the first non-invasive diagnostic test for fibrosis/cirrhosis in 2002. Innovation also applies to their scientific approach: the disruption of the liver biopsy 10 , new data analysis methodologies (METAVIR 11 , absence of perfect gold-standard 13 , biopsy gray zone 14 , spectrum effect 15 ) and their always cutting-edge statistical approach (obuschoswki 16 , DANA 17 , bayesian networks direct comparison 18 ) In addition to diagnostics, predicting risks of liver-related complications - including portal hypertension 19 and liver cancer 20 - in order to better identify the most appropriate response: FibroTest is the first non-invasive liver test to demonstrate a significant predictive value 21 . FibroTest is the first test to have proved its effectiveness for themass screening for cirrhosis and liver disease indifferent populations at risk: in general population 22 , among diabetics 23 and hyperlipidemics 24 . Quality Quality at all costs is a core priority of BioPredictive: as a technology that has been validated by over 300 clinical trials FibroTest is an approved way of diagnosing the four most common liver diseases, including specific populations including : HIV co-infected 25 , transplanted patients 26 27 , vasculitis 28 , haemophilia 29 or primary biliary cirrhosis 30 but also for a large age spectrum, from children 31 to elderly patients 32 . Quality and safety: BioPredictive's algorithms offer reliable diagnostic tools that give robust and reproducible results with an applicability of nearly 100% 33 . References Poynard T, Munteanu M, Charlotte F, Perazzo H, Ngo Y, Deckmyn O, Pais R, Merrouche W, De Lédinghen V, Mathurin P, Ratziu V. Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol Hepatol 2018;30:5. abstract article abstract abstract abstract Poynard T, De Lédinghen V, Zarski JP, Stanciu C, Munteanu M, Vergniol J, France J, Trifan A, Lenaour G, Vaillant JC, Ratziu V, Charlotte F. Performances of Elasto-FibroTest(®), a combination between FibroTest(®) and liver stiffness measurements for assessing the stage of liver fibrosis in patients with chronic hepatitis C. Clin Res Hepatol Gastroenterol 2012;36:5. abstract article Costa JM, Telehin D, Munteanu M, Kobryn T, Ngo Y, Thibault V, Joseph M, Ratziu V, Benhamou Y, Koz'ko V, Dubins'ka G, Poveda JD, Poynard T. HCV-GenoFibrotest: a combination of viral, liver and genomic (IL28b, ITPA, UGT1A1) biomarkers for predicting treatment response in patients with chronic hepatitis C. Clin Res Hepatol Gastroenterol 2011;35:3. abstract article Poynard T, Ratziu V, Naveau S, Thabut D, Charlotte F, Messous D, Capron D, Abella A, Massard J, Ngo Y, Munteanu M, Mercadier A, Manns M, Albrecht J. The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Comp Hepatol 2005;4:None. abstract article Poynard T, Ratziu V, Charlotte F, Messous D, Munteanu M, Imbert-Bismut F, Massard J, Bonyhay L, Tahiri M, Thabut D, Cadranel JF, Le Bail B, De Lédinghen V. Diagnostic value of biochemical markers (NashTest) for the prediction of non alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol 2006;6:None. abstract article Thabut D, Naveau S, Charlotte F, Massard J, Ratziu V, Imbert-Bismut F, Cazals-Hatem D, Abella A, Messous D, Beuzen F, Munteanu M, Taieb J, Moreau R, Lebrec D, Poynard T. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steato-hepatitis in patients with chronic alcoholic liver disease. J. Hepatol. 2006;44:6. abstract article Imbert-Bismut F, Ratziu V, Pieroni L, Charlotte F, Benhamou Y, Poynard T. Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: a prospective study. Lancet 2001;357:9262. abstract article Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet 1997;349:9055. abstract Poynard T, Aubert A, Bedossa P, Abella A, Naveau S, Paraf F, Chaput JC. A simple biological index for detection of alcoholic liver disease in drinkers. Gastroenterology 1991;100:5 Pt 1. abstract Poynard T, Ingiliz P, Elkrief L, Munteanu M, Lebray P, Morra R, Messous D, Bismut FI, Roulot D, Benhamou Y, Thabut D, Ratziu V. Concordance in a world without a gold standard: a new non-invasive methodology for improving accuracy of fibrosis markers. PLoS ONE 2008;3:12. abstract article Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin. Gastroenterol. Hepatol. 2012;10:6. abstract article Poynard T, Muntenau M, Morra R, Ngo Y, Imbert-Bismut F, Thabut D, Messous D, Massard J, Lebray P, Moussalli J, Benhamou Y, Ratziu V. Methodological aspects of the interpretation of non-invasive biomarkers of liver fibrosis: a 2008 update. Gastroenterol. Clin. Biol. 2008;32:6 Suppl 1. abstract article Poynard T, Munteanu M, Ngo Y, Castéra L, Halfon P, Ratziu V, Imbert-Bismut F, Thabut D, Bourliere M, Cacoub P, Messous D, De Lédinghen V. ActiTest accuracy for the assessment of histological activity grades in patients with chronic hepatitis C, an overview using Obuchowski measure. Gastroenterol. Clin. Biol. 2010;34:6-7. abstract article Poynard T, Halfon P, Castéra L, Munteanu M, Imbert-Bismut F, Ratziu V, Benhamou Y, Bourliere M, De Lédinghen V. Standardization of ROC curve areas for diagnostic evaluation of liver fibrosis markers based on prevalences of fibrosis stages. Clin. Chem. 2007;53:9. abstract article Houot M, Ngo Y, Munteanu M, Marque S, Poynard T. Systematic review with meta-analysis: direct comparisons of biomarkers for the diagnosis of fibrosis in chronic hepatitis C and B. Aliment. Pharmacol. Ther. 2016;43:1. abstract article Poynard T, Vergniol J, Ngo Y, Foucher J, Munteanu M, Merrouche W, Colombo M, Thibault V, Schiff E, Brass CA, Albrecht JK, Rudler M, Deckmyn O, Lebray P, Thabut D, Ratziu V, De Lédinghen V. Staging chronic hepatitis C in seven categories using fibrosis biomarker (FibroTest™) and transient elastography (FibroScan®). J. Hepatol. 2014;60:4. abstract article Poynard T, Vergniol J, Ngo Y, Foucher J, Thibault V, Munteanu M, Merrouche W, Lebray P, Rudler M, Deckmyn O, Perazzo H, Thabut D, Ratziu V, De Lédinghen V. Staging chronic hepatitis B into seven categories, defining inactive carriers and assessing treatment impact using a fibrosis biomarker (FibroTest®) and elastography (FibroScan®). J. Hepatol. 2014;61:5. abstract article Poynard T, Ngo Y, Perazzo H, Munteanu M, Lebray P, Moussalli J, Thabut D, Benhamou Y, Ratziu V. Prognostic value of liver fibrosis biomarkers: a meta-analysis. Gastroenterol Hepatol (N Y) 2011;7:7. abstract Poynard T, Lebray P, Ingiliz P, Varaut A, Varsat B, Ngo Y, Norha P, Munteanu M, Drane F, Messous D, Bismut FI, Carrau JP, Massard J, Ratziu V, Giordanella JP. Prevalence of liver fibrosis and risk factors in a general population using non-invasive biomarkers (FibroTest). BMC Gastroenterol 2010;10:None. abstract article Jacqueminet S, Lebray P, Morra R, Munteanu M, Devers L, Messous D, Bernard M, Hartemann-Heurtier A, Imbert-Bismut F, Ratziu V, Grimaldi A, Poynard T. Screening for liver fibrosis by using a noninvasive biomarker in patients with diabetes. Clin. Gastroenterol. Hepatol. 2008;6:7. abstract article Ratziu V, Giral P, Munteanu M, Messous D, Mercadier A, Bernard M, Morra R, Imbert-Bismut F, Bruckert E, Poynard T. Screening for liver disease using non-invasive biomarkers (FibroTest, SteatoTest and NashTest) in patients with hyperlipidaemia. Aliment. Pharmacol. Ther. 2007;25:2. abstract article Shaheen AA, Myers RP. Systematic review and meta-analysis of the diagnostic accuracy of fibrosis marker panels in patients with HIV/hepatitis C coinfection. HIV Clin Trials 2008;9:1. abstract article Varaut A, Fontaine H, Serpaggi J, Verkarre V, Vallet-Pichard A, Nalpas B, Imbertbismuth F, Lebray P, Pol S. Diagnostic accuracy of the fibrotest in hemodialysis and renal transplant patients with chronic hepatitis C virus. Transplantation 2005;80:11. abstract Beckebaum S, Iacob S, Klein CG, Dechêne A, Varghese J, Baba HA, Sotiropoulos GC, Paul A, Gerken G, Cicinnati VR. Assessment of allograft fibrosis by transient elastography and noninvasive biomarker scoring systems in liver transplant patients. Transplantation 2010;89:8. abstract article Sène D, Limal N, Messous D, Ghillani-Dalbin P, Charlotte F, Thiollière JM, Piette JC, Imbert-Bismut F, Halfon P, Poynard T, Cacoub P. Biological markers of liver fibrosis and activity as non-invasive alternatives to liver biopsy in patients with chronic hepatitis C and associated mixed cryoglobulinemia vasculitis. Clin. Biochem. 2006;39:7. abstract article Maor Y, Calès P, Bashari D, Kenet G, Lubetsky A, Luboshitz J, Schapiro JM, Penaranda G, Bar-Meir S, Martinowitz U, Halfon P. Improving estimation of liver fibrosis using combination and newer noninvasive biomarker scoring systems in hepatitis C-infected haemophilia patients. Haemophilia 2007;13:6. abstract article Friedrich-Rust M, Müller C, Winckler A, Kriener S, Herrmann E, Holtmeier J, Poynard T, Vogl TJ, Zeuzem S, Hammerstingl R, Sarrazin C. Assessment of liver fibrosis and steatosis in PBC with FibroScan, MRI, MR-spectroscopy, and serum markers. J. Clin. Gastroenterol. 2010;44:1. abstract article Hermeziu B, Messous D, Fabre M, Munteanu M, Baussan C, Bernard O, Poynard T, Jacquemin E. Evaluation of FibroTest-ActiTest in children with chronic hepatitis C virus infection. Gastroenterol. Clin. Biol. 2010;34:1. abstract article Thabut D, Le Calvez S, Thibault V, Massard J, Munteanu M, Di Martino V, Ratziu V, Poynard T. Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am. J. Gastroenterol. 2006;101:6. abstract article Poynard T, Munteanu M, Deckmyn O, Ngo Y, Drane F, Messous D, Castille JM, Housset C, Ratziu V, Imbert-Bismut F. Applicability and precautions of use of liver injury biomarker FibroTest. A reappraisal at 7 years of age. BMC Gastroenterol 2011;11:None. abstract article PRODUCTS · FibroTest-ActiTest · NASH-FibroTest New · FibroMax (legacy) · FibroTest · ActiTest · SteatoTest 2 New · NashTest 2 New · AshTest · All our products DO A TEST · Where to do the tests · Registration (Laboratories) · Technical Recommendations · Interpreting tests INNOVATION · Latest news · Scientific publications · Cov-Secure, a Covid-19 blood based test New COMPANY · Presentation · Our values · Contact us · Privacy policy ABOUT BIOPREDICTIVE BioPredictive is an independent bio-pharmaceutical company, based in France, which designs and markets diagnostic tests for liver diseases, in particular FibroTest and NASH-FibroTest. Contact us Twitter FaceBook SUBSCRIBE TO OUR NEWSLETTER: Email address: Subscribe