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Biohit Oyj
Recent clinical validation study confirms the accuracy of the new-generation GastroPanel® test in diagnosis of atrophic gastritis and Helicobacter pylori infection. (Cision)

2021-12-14 09:00

Biohit Oyj press release         14.12.2021 at 10.00 local time (EEST)

A new clinical validation study from Oulu University Hospital was recently published in a widespread international cancer journal (1), confirming that new-generation GastroPanel® test is highly accurate in diagnosing atrophic gastritis and Helicobacter pylori infection in gastroscopy referral patients.  

GastroPanel® biomarker test is a unique innovation of a Finnish biotechnology company (Biohit Oyj, Helsinki), designed for the first-line diagnosis of Helicobacter pylori (Hp) infection and atrophic gastritis (AG) among the patients with upper abdominal symptoms (dyspepsia) and esophageal reflux disease (GERD) in a simple blood test (2-6) (www.gastropanel.com). GastroPanel® is also the only test on the market monitoring the regulatory mechanism of acid output in the stomach (7). Because Hp and AG as well as high acid output are important risk conditions for gastric and esophageal cancer, the highly informative GastroPanel® is particularly suitable for a cost-effective, population-based screening of asymptomatic individuals for the risk of gastric and esophageal cancer, as confirmed in several studies from the high- and low-risk countries (6,8-12) (www.biohithealthcare.com/additional-information4).

On the track towards the GastroPanel® quick (POC) test, a new-generation (unified) GastroPanel® test was designed harmonizing the ELISA processing conditions of the 4 biomarkers. This new test version has recently undergone the first two clinical validation studies in patients at high risk for AG, i.e., autoimmune thyroid disease (AITD) and type 1 diabetes mellitus (DM1) (13) as well as in those with high Hp-prevalence (St. Petersburg, Russia) (14).

Prof. Kari Syrjänen, MD, PhD, Chief Medical Director (retired), Biohit Oyj:To satisfy the required formalities of the clinical validation of new tests in Europe, an adequately powered study was designed to evaluate the diagnostic accuracy of the new-generation GastroPanel® test in diagnosis of both AG and Hp-infection in patients referred for gastroscopy with different indications from the primary health care units (1). Together with the two previously published validation studies (13,14), this 100% biopsy-confirmed study was designed to verify that the diagnostic capabilities of the new-generation (unified) GastroPanel® test are compliant with the previous test version (4,5).

Dr. Olli-Pekka Koivurova, MD, the Principal Investigator of the study at Oulu: “Altogether, 522 consented patients were enrolled among the patients referred for gastroscopy at Gastro Center, Oulu University Hospital (OUH). All patients were blood sampled for GastroPanel® testing and underwent quality-controlled gastroscopy with mucosal biopsies that were used as the reference test, classified using the Updated Sydney System (USS) (1,13,14). In this cohort, biopsy-confirmed AG was found in 10.2% (53/511) of the patients. The overall agreement between the GastroPanel® and the USS classification was 92.4%. These results confirm that the new generation GastroPanel® is a highly accurate test for non-invasive diagnosis of atrophic gastritis and Hp-infection in dyspeptic patients referred for diagnostic gastroscopy (1).”

Additional information:
CEO Biohit Oyj, Mrs. Päivi Siltala,

CEO Päivi Siltala, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohit.fi

Biohit in brief

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 UK. Biohit's Series B share (BIOBV) is quoted on NASDAQ OMX Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com

References

1.Koivurova O-P, Koskela R, Blomster T, Ala-Rämi A, Lumme H,  Kettunen O,  Hukkanen J, Karttunen TJ, Mäkinen M, Ronkainen J, Syrjänen K. Serological biomarker panel in diagnosis of atrophic gastritis and Helicobacter pylori infection in gastroscopy referral patients. Clinical validation of the new-generation GastroPanel® test. Anticancer Res. 2021;41;5527-5537.

2. 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.

3.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.

4.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.

5.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. 

6.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.

7.Tiusanen T, Paloheimo L, Suovaniemi, O, Syrjänen K. Serological biomarker test (GastroPanel®) in diagnosis of functional gastric disorders, Helicobacter pylori and atrophic gastritis in a random sample of patients referred for testing due to dyspeptic symptoms. Anticancer Res. 2021; 41:811-819.

8.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.

9.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 multi-centre study. Gut 2019; 68:1576-1587.

10.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

11.www.biohithealthcare.com /News/Reading material: State of the art GastroPanel and Acetium innovations for the unmet need  

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

13.Koivurova O-P, Ukkola O, Koivikko M, Ebeling T, Yliaska I, Koskela R,  Blomster T, Ala-Rämi A, Kettunen O, Karttunen TJ, Mäkinen M, Ronkainen J,  Syrjänen K. Screening of the patients with autoimmune thyroid disease (AITD) and type 1 diabetes mellitus (DM1) for atrophic gastritis (AG) by serological biomarker testing (GastroPanel®). EC Gastroenterol. Digest. Syst. 2020; 7:181-195.

14.Mäki M, Söderström D, Paloheimo L, Hendolin P, Suovaniemi O, Syrjänen K. Helicobacter pylori (Hp) IgG ELISA of the new-generation GastroPanel® is highly accurate in diagnosis of Hp-Infection in gastroscopy referral patients.  Anticancer Res. 2020; 40:6387-6398.


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