New clinical validation study confirms accuracy of GastroPanel® blood test compared to gastroscopy with biopsies for diagnosis of atrophic gastritis and H. pylori infection.



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 patients with upper abdominal symptoms (dyspepsia) and oesophageal reflux disease (GORD) in a simple blood test. GastroPanel® is also the only test on the market monitoring the regulatory mechanism of acid output in the stomach. Because Hp and AG as well as high acid output are important risk conditions for gastric and oesophageal cancer, the highly informative GastroPanel® is particularly suitable for a cost-effective, population-based screening of asymptomatic individuals for the risk of gastric and oesophageal cancer, as confirmed in several studies from the high- and low-risk countries.


Whilst developing the new 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) (2), as well as in those with high Hp-prevalence (3).


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 (2,3), 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.


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) (1,2,3). 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).”


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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. 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.

  3. 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.