Recent clinical validation study confirms the accuracy of the new-generation GastroPanel® test in diagnosis of atrophic gastritis and Helicobacter pylori infection.
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
[email protected]
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
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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.
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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.
