International group of experts revisits the value of traditional Helicobacter tests (13C urea breath test and stool antigen test) in their critical review

Biohit Oyj press release 04.02.2019

International group of multidisciplinary experts from China, Italy, Estonia and Finland, has written a comprehensive and critical review on advantages and limitations of the Helicobacter tests as screening tools of gastric cancer. This comprehensive review has been recently accepted for publication in a widespread international cancer journal (Anticancer Research), and it will appear in the next issue of the journal (1).

This review consists of two parts:

1) a detailed discussion based on comprehensive literature review on the most commonly used Helicobacter tests (13C urea breath test or UBT and stool antigen test, SAT) with special reference to their use and serious limitations;

2) the second part of the review makes a detailed treatise how these caveats can be avoided by using a simple blood test based on a panel of four biomarkers (GastroPanel®, Biohit Oyj).

The serious limitations of the conventional Helicobacter tests have been previously discussed in single publications (2,3), and the same applies to the use of GastroPanel® test in diagnosis of Helicobacter infections (4). This new review (1) has a wide authorship of experts who represent internationally recognised authorities and scientists in their field. In addition of being highly critical towards the currently used UBT and SAT tests (1), the review is not limited in only listing the serious limitations of UBT and SAT that endanger the patient safety at worst, but the review provides a detailed discussion of a concrete solution, how the Helicobacter diagnostics should be updated to meet the present-day needs by moving to use of  GastroPanel® test (www.gastropanel.com). 

The Finnish GastroPanel-innovation endorses the primary prevention, improves patient safety and produces savings in the health care costs. Using GastroPanel in the screening of the different risk factors of gastric cancer would avoid e.g. the possible unnecessary gastric cancer deaths, and according  to the cost-efficiency model by Nordic Healthcare Group (NHG), systematic GastroPanel testing of ten age-groups (55-64-year-olds) would lead to savings of over 800 million euro of their life-time health care costs in Finland (https://www.gastropanel.com/decision-makers/screening-model). GastroPanel-detected i) symptomatic Helicobacter-infection after eradication therapy; ii) atrophic gastritis with related risks, such as gastric cancer or iii) symptomatic high acid output with related risks, such as esophageal cancer are all indications for gastroscopy (www.biohithealthcare.com/additional-information ).

In our national health care, achieving cost savings and primary prevention of different diseases necessitate a nationwide use of GastroPanel in the first-line diagnosis of dyspeptic symptoms and in health monitoring of asymptomatic subjects. Because of the fact that particularly among older people, upper gastric complaints can often be of colonic origin, the diagnostic panel of dyspeptic patients should benefit from the inclusion of another Finnish innovation, ColonVIew-FIT test. This test is highly specific to human blood, and helps finding the early-stage colorectal cancer and their precursor lesions (polyps and adenomas), for the reach of a curative therapy. 

CEO Semi Korpela, Biohit Oyj: ”On the basis of an extensive published literature, further confirmatory evidence is obtained implicating that several clinical conditions can cause serious   sources of errors in both UBT and SAT test results  (2,3). False negative results are common in conditions where Helicobacter load in the gastric mucosa is low. Such conditions include: 1) chronic use of PPI-medication; 2) use of antibiotics; 3) bleeding peptic ulcer; 4) atrophic gastritis; 5) gastric cancer; 6) MALT lymphoma and 7) gastric resection surgery (2,3). UBT also gives false positive results in cases where urease-positive bacterial species will colonize in an acid-free  stomach resulting from atrophic gastritis or long-term use of PPI-medication (2,3).”

The first author of the review (1), prof. Kari Syrjänen (CEO, SMW Consultants Ltd): ”The third  important limitation of UBT and SAT is that neither of these tests is capable of detecting atrophic gastritis of Helicobacter or autoimmune origin, thus missing the patients at high risk for i) gastric cancer, ii) esophageal cancer, iii) vitamin B12-deficiency, or malabsorption of iv) calcium, iron, magnesium, zinc and certain medicines (1,2,3,4). GastroPanel® test  accuretly detects atrophic gastritis and Helicobacter-infection. Furthermore, this test will disclose, whether a) Helicobacter infection is active, b) eradication therapy has been successful, or c) eradication therapy has failed (2,3,4). Due to all these unique properties, GastroPanel® test  can be considered as the most comprehensive Helicobacter test on the market, increasing the patient safety and reducing the costs in diagnosis of dyspeptic symptoms and in monitoring stomach health (1,5, www.biohithealthcare.com/additional-information).”

References

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 Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review. Anticancer Res. Painossa. 2019.

2.Syrjänen K. False negative and false positive results in diagnosis of Helicobacter pylori infections can be avoided by a panel of serum biomarkers (GastroPanel). M. J. Gast. 1 (1), 007-014, 2017.

3.Syrjänen K. Caveats in diagnosis of Helicobacter pylori infection can be avoided by a panel of serum biomarkers (GastroPanel®). An invited Editorial. J. Carcinog. Mutagen 2016. 7(6), e123.doi:10.4172/2157-2518.1000e123.

4.Syrjänen K. Serological biomarker panel (GastroPanel®): A test for non-invasive diagnosis of dyspeptic symptoms and for comprehensive detection of Helicobacter pylori infection. Biomark. J. 3, 1-10, 2017.

5. Agreus 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, Sung J. Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers. Scand J Gastroenterol 47,136-147, 2012.

Additional information:
CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
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 Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com