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Biohit GastroPanel[®] test was studied clinically in patients with autoimmune disease

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Press release 25.09.2020 at 15.00 local time (EEST)

 

This study was completed at the Outpatient Department of Internal Medicine (Oulu University Hospital), and the report of the results was recently accepted for publication in an international gastroenterology journal (1). 

At the moment endoscopic services have been severely curtailed due to the COVID-19 pandemic. This further increases the risk of patients with autoimmune disease developing autoimmune atrophic gastritis (AAG) and even gastric cancer before diagnosis can be made. Biohit´s solution is to use the GastroPanel® test to screen these patient groups and stratify those who are in urgent need of endoscopic services (2-4, 11, 16, 17).

GastroPanel® is a four-biomarker test: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori antibody (HpAb), and as such represents 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. This first non-invasive diagnostic test on the market accurately confirms or excludes the presence of Hp infection and atrophic gastritis (AG) (2, 8-13).

At the same time, GastroPanel® is the only test monitoring the state of acid output regulation 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 with substantial savings in life-time health care costs (5-8-14).

The study was targeted to patients with two autoimmune diseases: type 1 diabetes mellitus (DM1) and autoimmune thyroid disease (AITD), known to have a high prevalence of AG and autoimmune AG (=AAG).

Adjunct professor Minna Mäki, PhD, Director of R & D, Biohit Oyj: “The authors conclude that AG/AAG is far more prevalent among the AITD- and DM1 patients than in the general population. The new generation GastroPanel® is an ideal test for non-invasive screening of these patients for early diagnosis of AG/AAG. In this study, a cohort of 244 patients: 207 with AITD and 37 with DM1, was enrolled during 2017-2019. All patients underwent GastroPanel® examination and those with AG/AAG biomarker profile were referred for gastroscopy and biopsy confirmation (the reference test). Of the 244 patients, biopsy-confirmed AG/AAG was found in 12.0 % (25/207) of the AITD- and in 10.8 % (4/37) of the DM1 patients. The overall agreement between GastroPanel® diagnoses (5 categories) and the gastroscopic biopsies (the same 5 diagnostic categories) was 88.1 % (95 % confidence interval, CI=78.3-93.5 %). The combined sensitivity and specificity of the GastroPanel test biomarker PGI in diagnosis of moderate/severe AG/AAG of the corpus was 93.9 % (95 %CI 87.0-100 %) and that of the PGI/PGII ratio even higher: 94.5 % (95 %CI 87.9-100 %) (1).” 

CEO Semi Korpela, Biohit Oyj: “Substantial savings in health care costs could be achieved by the use GastroPanel® test with better allocation the endoscopic resources in primary care (10,14). It sounds feasible that the convincing evidence provided by this clinical study (1) would be soon adopted in the follow-up of these high-risk patients also in Finland, similarly as recommended by the Russian Federation for monitoring of the GC risks (15). In contrast to the fallacious statements of the national management guidelines in Finland (16). 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/AAG and the state of gastric acid output (3, 4,16, 17).”

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

www.biohithealthcare.com

 

References

  1. Koivurova OP, 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; in press.

  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.

  1. 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.

  1. 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. 

  1. 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.

  1. 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.

  1. 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

  1. www.gastropanel.com

  1. 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.

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

  1. www.biohithealthcare.com/additional-information

  1. 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.

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

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

  2.  www.biohithealthcare.com/Critisism-about-current-care-recommendations
  3. Annual general meeting 2020, Osmo Suovaniemi: https://www.biohithealthcare.com/wp-content/uploads/2020/09/Osmon-puhe-2020-Final-EN.pdf

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 Helsinki in the Small cap/Healthcare group.

www.biohithealthcare.com

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