Biohit Oyj press release                                 15.2.2022 at 10.00 local time (EEST)

In December 2021, the Ministry of Health of the Russian Federation made public new official clinical guidelines on the diagnostic practices to be followed for all patients with suspected gastritis or duodenitis (1). According to these new guidelines, "all patients with suspected precancerous changes in the stomach with gastritis (atrophy, intestinal metaplasia) in order to confirm the diagnosis, assess the risk of developing gastric cancer and determine the order of endoscopic observation is recommended to conduct a blood test for Pepsinogen I, Pepsinogen II and Gastrin-17" (1). In Russian Federation, these official guidelines of the Ministry of Health are mandatory and need to be strictly followed in the clinical practice (2). Level of persuasiveness of this recommendation is: A, i.e., represents the highest level of documentation (1).

The whole document (in Russian language) is found in the link (https://tinyurl.com/2p99fnc4)(1). This long document is based on convincing clinical evidence abundantly cited in the document, where also the original references [numbers in brackets] are found.

In brief, the diagnosis of atrophic gastritis has become more accessible thanks to serum biomarkers of atrophy of the mucous membrane of the body and the antrum of the stomach. Low serum pepsinogen I is highly sensitive and specificity (84% and 95%, respectively) in the diagnosis of severe mucosal atrophy of the gastric corpus. Atrophy of the antrum is characterized by low levels of basal and postprandial gastrin-17(G-17) due to a decrease in the number of G cells (1,3,4,6,7).

In a study conducted in the Russian Federation, gastric cancer has been associated with low levels of pepsinogen I (ratio odds (OR) 2.9, low ratio pepsinogen I/II ratio (OR 3.3), low levels of gastrin-17 (OR 1.8; 95% CI 0.7-4.8)[45]. These Russian data corroborate with two recent GastroPanel® meta-analysis published in Italy (9) and Finland (8), implicating that the pooled sensitivity of GastroPane® in diagnosis of atrophic corpus gastritis is 74.7% and specificity 95.6%, with negative predictive value of 91%.  

Biohit Oyj, Päivi Siltala, CEO: "The GastroPanel® innovation of Biohit Oyj is the only biomarker panel (Pepsinogen I, Pepsinogen II, Gastrin.17 and Helicobacter pylori IgG antibodies, interpreted by GastroSoft® application) on the market that can reliably detect Helicobacter pylori (Hp) infection and Hp-associated or autoimmune type of atrophic gastritis (3-13). This official recommendation of the Russian Federation (1) must be considered of major importance for the company. The Russian Federation is one of the most important market areas of Biohit Oyj, and we already have a significant foothold in this region."

Melon Co. Ltd (St. Petersburg), Georgy Pobeliansky, CEO: "GastroPanel® biomarkers (www.gastropanel.com ) can be used to identify timely and reliably the patients suffering from upper gastrointestinal disorders who need to undergo gastroscopy. This test is exactly the diagnostic tool that the new guidelines call upon. The simple GastroPanel® blood biomarker test is also a much more patient-friendly and cost-effective way to examine the stomach mucosa, as compared with the invasive endoscopy. After release of this official mandatory guideline, we expect significant growth in sales of GastroPanel®. However, these recommendations have  been released just recently, and it will take some time to convey this information to our consumers."

For more information please contact:

CEO Päivi Siltala, Biohit Oyj

Tel. +358 9 773 861

www.biohithealthcare.com

investor.relations@biohit.fi

Biohit Oyj

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. Clinical guidelines - Gastritis and duodenitis - 2021-2022-2023 (20.12.2021) - Approved by the Ministry of Health of the Russian Federation. https://tinyurl.com/2p99fnc4

2. Skvortsova VI. Letter of the Minister of Health of the Russian Federation, 06.10.2017 No. 17-4/10/2-6989.

3. https://www.biohithealthcare.com/additional-information

4. 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.

5. Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P. Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K and El-Omar EM: on behalf of the European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection - the Maastricht V/Florence Consensus Report. Gut 66(1): 6-30, 2017.

6. 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 47(12): 136-147, 2012.

7. Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis.Gut. 2015 Sep;64(9):1353-67.

8. 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.

9. Zagari RM, Rabitti S, Greenwood DC, Eusebi LH, Vestito A, 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;1-11.

10. https://www.biohithealthcare.com /News/Reading material: State of the art GastroPanel and Acetium innovations for the unmet need (https://www.biohithealthcare.com/wp-content/uploads/2019/02/state-of-the-art-gastropanel-and-acetium-innovations-suovaniemi-2011.pdf)

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

12. https://www.biohithealthcare.com /Investors/Stock Exchange Releases:

2020-03-12T08:00:00Z - Population-based screening by Biohit GastroPanel[®] biomarkers practically eliminates the risk of gastric cancer during a long-term follow-up (https://news.cision.com/biohit-oyj/r/population-based-screening-by-biohit-gastropanel--biomarkers-practically-eliminates-the-risk-of-gast,c3057345)

13. Kurilovich S, Belkovets A, Reshetnikov O, Openko T, Malyutina S, Ragino Y, Scherbakova L, Leja M, Paloheimo L, Syrjänen K, Voevoda M. Stomach-specific biomarkers (GastroPanel) can predict the development of gastric cancer in a Caucasian population: A longitudinal nested case-control study in Siberia. Anticancer Res 2016;36(1):247-253. (http://ar.iiarjournals.org/content/36/1/247.full.pdf+html)