A study from Italy confirms: Low levels of G-17 biomarker of the Biohit GastroPanel® test predict the risk of esophagitis and esophageal reflux disease (GERD)

Biohit Oyj Press Release 20.04.2021 at 1:00 pm local time (EEST)

A recent study provided significant new information on the associations of GastroPanel^® G-17 biomarker with esophagitis and gastroesophageal reflux disease (GERD) symptoms. Italian study was published by the research group of Professor Di Mario from Parma University, who have substantial previous experience on GastroPanel® test (1).

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 (2,3) (www.gastropanel.com, www.biohithealthcare.com /News/Links: GastroPanel innovation). At the same time, GastroPanel® is the only test monitoring the acid output regulatory mechanism in the stomach. Because Hp and AG as well as high acid output are the most important risk conditions for gastric and esophageal cancer, the highly informative GastroPanel® is also particularly suitable for a cost-effective, population-based screening of asymptomatic individuals for the risk of gastric and esophageal cancer (2-5,12) (www.biohithealthcare.com/additional-information4).

Of the four GastroPanel^® biomarkers, G-17 is the most multifaceted. Being synthesized in the gastric antrum, G-17 is a biomarker of its function and structure: low levels of G-17 can be a sign of antrum atrophy, which is invariably associated with Hp-infection (6-8). A significantly more common cause of low G-17 levels is, however, increased gastric acid output, whereas atrophy of the gastric corpus (with the resulting acid-free stomach) will typically cause a marked increase of G-17 levels  (2,3,6-8,13). Clinically much less attention has been paid to the regulatory effects of G-17 on the lower esophageal sphincter muscle. When low G-17 levels are due to increased gastric acid output, the risk of esophageal reflux disease (GERD) is increased, with resulting erosive or non-erosive esophagitis, which can develop to Barrett’s esophagus and lower esophageal cancer (9,10). The following conditions detected by GastroPanel® test: i) symptomatic Hp-infection after eradication therapy; ii) AG, or iii) symptomatic high acid output (low G-17), are all indications for endoscopic examination (www.biohithealthcare.com/additional-information).  

Prof. Kari Syrjänen, Chairman of the Scientific Advisory Board, Biohit Oyj: “In clinical practice, most patients with symptoms suggestive of gastroesophageal reflux disease (GERD) undergo esophago-gastro-duodenoscopy (EGD)(1,8-9), despite its low sensitivity in detecting reflux symptoms. As pointed out above, the reciprocal relationship between G-17 and acid output is well appreciated (9,10), and e.g. for this reason, G-17 has been proposed to be related with GERD symptoms (1,9,10,13). The research group of Professor Di Mario assessed the clinical usefulness of fasting G-17 serum determination for a non-invasive diagnosis of GERD in patients with typical symptoms (1). The authors enrolled patients complaining of typical GERD symptoms in two different settings: a single referral center and a primary care setting as well as similar control groups consisting of dyspeptic patients (1). All subjects underwent assessment of serum levels of G-17, and the diagnoses were confirmed by endoscopic examination (EGD).”

Prof. Osmo Suovaniemi, Chairman of the Board, Biohit Oyj: “At the academic hospital, GERD patients (with erosive esophagitis and with Barrett’s esophagus) had statistically significantly lower levels of G-17 as compared with the dyspeptic patients. Similarly, in the primary care setting, the GERD patients had statistically significantly lower levels of G-17 as compared with the dyspeptic control patients. Importantly, no statistically significant differences were found in G-17 levels between the patients with i) erosive and ii) non-erosive esophagitis. In the primary health care, the diagnostic accuracy of G-17 (with the 1 pmol/l cut-off) to detect non-invasively GERD was as high as 94.3 % (1). From the patients’ point of view, these results are particularly important and further extend the scope of gastric diseases and functional disorders detectable by GastroPanel® test (3,6-9,11,12), while confirming that G-17 biomarker is a reliable predictor of erosive and non-erosive esophagitis as well as esophageal reflux disease (GERD), equally well in the primary health care and in a university clinic (1).”  

Additional information:

Chairman of Biohit Oyj’s Board of Directors Osmo Suovaniemi
Tel. +358 9 773 861, investor.relations@biohit.fi
www.biohithealthcare.com

Biohit Oyj 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 United Kingdom. Biohit’s series B share (BIOBV) is quoted on NASDAQ OMX Helsinki, Small cap/Healthcare. www.biohit.fi

References

1.Di Mario F, Crafa P, Franceschi M,  Rodriguez-Castro, KI, Baldassarre G, Ferronato A, Antico A,  Panozzo, MP, Franzoni L, Barchi A, Russo M, de Bortoli N, Ghisa M, Savarino E. Low levels of Gastrin 17 are related with endoscopic findings of esophagitis and typical symptoms of GERD. J Gastrointestin Liver Dis 2021;30:1-5.

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.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(9):181-195.

7.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.

8.Tiusanen T, Paloheimo L, Suovaniem, 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.

9.Sipponen P, Vauhkonen M, Helske T, Kääriäinen I, Härkönen M. Low circulating levels of gastrin-17 in patients with Barrett’s esophagus. World J Gastroenterol 2005;11:5988–5992.

10. Straathof JW, Lamers CB, Masclee AA. Effect of gastrin-17 on lower esophageal sphincter characteristics in man. Dig Dis Sci 1997;42:2547-2551.

11.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.

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

13.Crafa P, Franceschi M,  Rodriguez Castro KI, Barchi A, Russo M, Franzoni L, Antico A,  Baldassarre G, Panozzo MP, Di Mario F. Functional dyspepsia. Acta Biomed 2020;91(3): e2020069 DOI: 10.23750/abm.v91i3.10150