The usefulness of Biohit GastroPanel[®] biomarkers in diagnosis of atrophic gastritis confirmed in a multi-center study in France

Biohit Oyj press release    

6.8.2020 at 10.05 local time (EEST)

GastroPanel® biomarker test is a unique innovation of a Finnish biotechnology company (Biohit Oyj, Helsinki), designed for the first-line diagnosis of all patients with upper abdominal symptoms (dyspepsia) and reflux complaints (1,2). This first non-invasive diagnostic test on the market accurately confirms or excludes the presence of Helicobacter pylori (Hp) infection and atrophic gastritis (AG) (1,2). At the same time, GastroPanel® is the only test monitoring the acid output regulatory mechanism in the stomach. Hp and AG are the two most important risk conditions for gastric cancer (GC), and because of this, GastroPanel® is also particularly suitable for population-based screening of asymptomatic individuals for the risk of GC, as confirmed in several studies from the high- and low-risk countries (4-7).

A significant confirmatory evidence to the previous studies on GastroPanel® biomarkers in diagnosis of AG and related gastric pathologies (3,4) was provided by a recently published multi-center study from France (8). This prospective multi-center study from a low-risk region of GC was conducted by the researches in the University Hospital of Nantes (Prof. Tamara Matysiak-Budnik and her team), but included also centers from other French cities (8). The authors enrolled a cohort of 344 patients (148 cases with AG, 196 controls without AG), who were tested with GastroPanel® and examined by gastroscopy and biopsies (8).

Director Jean-Claude Barral, Mast Diagnostic: “In this prospective multi-center study, 344 consecutive patients assumed to be at an increased risk of GC underwent gastroscopy and biopsies, used as the reference to compare the GastroPanel® results. GastroPanel® biomarker panel showed a better overall performance for the diagnosis of AG than Pepsinogen I as a stand-alone marker, with the sensitivity (Se), specificity (Sp), positive (PPV)- and negative predictive value (NPV) of 61.0 %, 98.5 %, 92.2 % and 89.8 % for AG of the corpus (8). The Se increased with the severity of AG, being 60.8% for moderate/severe AG at any site, and 72.7 % for moderate/severe AG of the corpus (8). These figures are in perfect agreement with the results reported in the two meta-analysis covering all published GastroPanel® studies until 2015/2016 (3,4), with pooled Se of 74.7 % and pooled Sp 95.6 % (3,4). The conclusion of the French study (8) stating that “the GastroPanel test is particularly effective for the detection of advanced corpus atrophy” is easy to agree,” confirms Mr Jean-Claude Barral.

CEO Semi Korpela, Biohit Oyj: “Given that substantial savings in health care costs could be achieved by systematic use of GastroPanel test (9,10). For instance The Russian Federation’s guideline requires: A panel of four biomarkers (GastroPanel: pepsinogen I, pepsinogen II, gastrin-17 and Hp-antibody test) should be used to assess the state of gastric mucosa before undergoing gastroscopy among the low-risk patients for gastric cancer (11). In addition to being used for screening of the risk of gastric and esophageal cancer, i.e., AG with its serious clinical sequels (deficiency of vitamin B12, iron, calcium and magnesium), GastroPanel® is the first-line diagnostic test for Hp-infection, dyspepsia and reflux symptoms. In this indication, GastroPanel® is superior to 13C urea breath test (UBT) and stool antigen test (SAT), that fail to diagnose AG (with all related risks) and monitor the state of gastric acid output. In addition, these tests may give false negative results for H. pylori infection in a substantial proportion of cases (12-15).”

 

Additional information:
CEO and President Semi Korpela, Biohit Oyj
tel. +358 9 773 861

investor.relations@biohit.fi
www.biohit.fi

 

References

1. Agréus L, Kuipers EJ, Kupcinskas L, Malfertheiner P, Di Mario F, Leja M, Mahachai V, Yaron N, van Oijen M, Perez Perez G, Rugge M, Ronkainen J, Salaspuro M, Sipponen P, Sugano K and Sung J: Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers. Scand J Gastroenterol 2012;47:136-147.

2.Syrjänen K, Eskelinen M, Peetsalu A, Sillakivi T, Sipponen P, Härkönen M, Paloheimo L, Mäki M, Tiusanen T, Suovaniemi O, DiMario F, Fan ZP.  GastroPanel® Biomarker Panel: The most comprehensive test  for Helicobacter pylori infection and its clinical sequelae. A critical review. Anticancer Res 2019;39:1091-1104.

3.Syrjänen K: A Panel of serum biomarkers (GastroPanel®) in non-invasive diagnosis of atrophic gastritis. Systematic review and meta-analysis. Anticancer Res 2016;36: 5133-5144.

4.Zagari RM, Rabitti S, Greenwood DC, Eusebi LH, Vestito A and Bazzoli F: Systematic review with meta-analysis: Diagnostic performance of the combination of pepsinogen, gastrin-17 and anti-Helicobacter pylori antibodies serum assays for the diagnosis of atrophic gastritis. Aliment Pharmacol Ther 2017;46:1-11. 

5.Kurilovich SA, Belkovets AV, Reshetnikov OV, Openko TG, Malyutina SK, Ragino YI, Scherbakova LV, Leja M, Paloheimo L, Syrjänen K, Voevoda MI. Stomach-specific biomarkers (GastroPanel) can predict the development of gastric cancer in Caucasian population: A longitudinal nested case-control study in Siberia. Anticancer Res 2016;36:247-254.

6.Tu H, Sun L, Dong X, Gong Y, Xu Q, Jing J, Bostick RM, Wu X and Yuan Y: A Serological biopsy using five stomach-specific circulating biomarkers for gastric cancer risk assessment: A multi-phase study. Am J Gastroenterol 2017;112:704-715.

7.Cai Q,  Zhu C, Yuan Y, Feng Q, Feng Y, Hao Y et al. and Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA). Development and validation of a prediction rule for estimating gastric cancer risk in the Chinese high-risk population: a nationwide multicentre study. Gut 2019;0:1–12. doi:10.1136/gutjnl-2018-317556

8.Chapelle N, Petryszyn P, Blin J, Le Berre-Scoul  C, Jirka I, Neunlist M, Moussata D, Lamarque D, Olivier R, Tougeron D, Mosnier J-F, Matysiak-Budnik T. A panel of stomach-specific biomarkers (GastroPanel®) for the diagnosis of atrophic gastritis: A prospective, multicenter study in a low gastric cancer incidence area. Helicobacter 2020;00:e12727. https://doi.org/10.1111/hel.12727

9. www.biohithealthcare.com /Links: State of the art diagnosis of Helicobacter pylori and State of the art GastroPanel and Acetium innovations for the unmet need.

10. https://www.gastropanel.com/decision-makers/screening-model

11. Ministry of health of Russian Federation website: https://democenter.nitrosbase.com/clinrecalg5/Files/recomend/МР108.PDF

12. www.biohithealthcare.com/wp-content/uploads/2019/11/Critisism-about-current-care-recommendations.pdf

13. www.biohithealthcare.com/ Links: GastroPanel Innovation

14. Syrjänen K, Eskelinen M, Peetsalu A, Sillakivi T, Sipponen P, Härkönen M, Paloheimo L, Mäki M, Tiusanen T, Suovaniemi O, DiMario F, Fan ZP.  GastroPanel® Biomarker Panel: The most comprehensive test  for Helicobacter pylori infection and its clinical sequelae. A critical review. Anticancer Res 2019;39:1091-1104.

15. www.biohithealthcare.com/additional-information

Biohit Oyj is a globally operating Finnish biotechnology company. Biohit’s mission is "Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the United Kingdom. Biohit’s series B share (BIOBV) is quoted on NASDAQ OMX Helsinki, Small cap/Healthcare. www.biohit.fi

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