Biohit GastroPanel® biomarkers validated as powerful predictors of gastric cancer risk in a multicenter study

Press release

Biohit Oyj

9^th April 2019 at 09.30 local time (EEST)

Biohit GastroPanel^® innovation is the unique non-invasive diagnostic tool for examination of i) dyspeptic patients for exclusion or diagnosis of Helicobacter pylori (Hp) infection and atrophic gastritis (AG), also disclosing the functional status of gastric acid output, as well as
ii) for screening of asymptomatic individuals for the risk of gastric cancer (GC)(1,2, www.gastropanel.com, www.biohithealthcare.com/additional-information). The outstanding performance of GastroPanel^® test in diagnosing AG has been validated in a large number of clinical studies recently summarised in two meta-analyses (3,4). Population-based studies assessing the value of GastroPanel^® biomarkers as predictors of GC have been more rare (5,6).

A significant confirmatory evidence to the existing data on GastroPanel^® biomarkers as predictors of GC was provided by a recently published nationwide multicentre study from China (7), where an extensive study group headed by professor Cuancai Cai from Changhai Hospital, Naval Medical University (Shanghai, China) studied a Chinese population at high risk for GC. In this extensive cohort of 14 929 subjects, the authors aimed to develop a prediction algorithm (risk factor combination) to be used as an initial pre-screening tool for identifying individuals at high risk for GC, before subjected to confirmatory gastroscopy (7).

In this nationwide multi-centre cross-sectional study, the authors examined individuals between 40–80 years of age who attended the hospitals to participate in gastroscopy screening for GC. Serum pepsinogen PG I, PG II, gastrin-17 (G-17) and anti-Hp pylori IgG antibody levels were measured by the Biohit GastroPanel^® prior to endoscopy. Eligible participants (n=14 929) were randomly assigned into two cohorts: i) the derivation (=study) cohort and ii) validation cohort, with a ratio of 2:1 (7). Risk factors for GC were identified by univariate and multivariate analyses and an optimal prediction rule (=combination of predictors) was then compiled.

Adjunct professor Minna Mäki, PhD, RD and production director, Biohit Oyj: "In this study, the GC risk prediction panel comprised seven predictors (age, sex, PG I/II ratio, G-17, Hp Ab titre, pickled food and fried food), with combined scores ranging from 0 to 25 (7). The observed prevalence rates of GC among the low-risk (score =11), medium-risk (score 12–16) or high-risk individuals (score 17–25) were 1.2 %, 4.4 % and 12.3 %, respectively (p<0.001). When gastroscopy was used for individuals with medium risk and high risk, 70.8 % of the total GC cases and 70.3 % of the early GC cases were detected (7). This combination of predictors was shown to have a good discrimination power, with an area under curve (AUC) of 0.760 (p<0.001)(7).”

CEO Semi Korpela, Biohit Oyj: "This important study provides additional confirmatory evidence to the two previous studies, where GastroPanel^® biomarkers were shown to be significant independent predictors of incident GC in population-based longitudinal settings (5,6). Similar as in these two studies (5,6), also in this Chinese study (7), all GastroPanel biomarkers (PGI/PGII ratio, G-17, Hp antibodies) proved to be significant independent predictors of GC in a multivariate model. This new risk predictor combination showed a good performance in identifying individuals at the highest risk for GC among a Chinese high-risk population. Of particular practical value and potential relevance also for example to the Finnish population is the fact that the number of endoscopies could be reduced by 66.7% by using the low-risk score cut-off of this predictor combination (7). Interestingly, this corroborates to the best estimates in Finland, suggesting that up to 80 % of gastroscopies could be avoided and, in addition, a huge amount of costs could be saved by systematic screening by GastroPanel (1,2,8,9).”

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

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

Additional information:
CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohit.fi

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