The new GastroPanel® Quick Test of Biohit Oyj clinically validated in a high-risk population in India
Biohit Oyj Press Release 12.5.2025 at 2.00 pm local time (EEST)
The latest Biohit innovation- GastroPanel® quick test (GPQT)- represents the most advanced state-of-art technology in the non-invasive serological diagnosis and screening of the patients at high risk for gastric cancer (GC)(1). The GPQT is intended for POC (Point-of-Care) diagnosis at a single clinical appointment and designed to give exactly the same information as the GastroPanel® ELISA test versions (2-4). GPQT was recently validated in a major gastroenterology clinic (Fortis Hospital, Mohali Chandigarh) in India, which is one of the high-risk countries for GC (5).
Two risk factors of GC exceed all the others in importance: i) Helicobacter pylori (Hp) infection and ii) atrophic gastritis (AG)(6-8). The risk of GC increases in parallel with the severity of AG up to 90-fold in patients with severe AG both in the corpus and in the antrum (so called pan-gastritis; AGP)(6-9). It is estimated that of all Hp-infected patients (roughly 40-50% of the world population), 5-10% eventually develop moderate to severe AG, if Hp is not eradicated (9).
In the early 2000’s, an increasing demand of a non-invasive diagnostic test to replace the expensive endoscopy in diagnosis of GC risk conditions, paved the way to the design of a 4-biomarker panel (GastroPanel® test)(GP) that combines serum pepsinogen I (PGI) and II (PGII), gastrin-17 (G-17), and Hp antibody (Hp IgG) as an ELISA test, by Biohit Oyj (Helsinki, Finland)(2). Primarily used in diagnosis and screening of Hp-infections and AG, GP test also accurately measures the state of gastric acid output (2-4).
The GP test has gained increasing global interest, with rapidly expanding diagnostic accuracy (DA) studies in different clinical and screening settings (4). The latest meta-analysis covering all published literature until 2022, reported a pooled sensitivity (SE) of 70-75% and a pooled specificity (SP) close to 95% for the GP test in diagnosing AG of the corpus (AGC) (10). These data also include the convincing results obtained with the latest GP ELISA version (unified-GP) that harmonizes the laboratory processing conditions of the 4 biomarkers (11). Being a lateral flow test, GPQT results are read in 15 minutes with the GastroPanel® Reader instrument (GP reader NT)(12), and their interpretation is based on the same diagnostic GastroSoft® algorithm as in all GP ELISA versions (2-4).
The clinical validation study of the GPQT was recently concluded at Fortis Hospital (Mohali Chandigarh, India), and the study results have been published (13). Altogether, 266 patients were enrolled among the consecutive gastroscopy referrals at the Department of Gastroenterology during 2022-2023. All patients were subjected to finger prick blood sampling for GPQT testing, and underwent gastroscopy with biopsies (classified using the Updated Sydney System, USS) and used as the reference test to calculate the DA of GPQT (13).
Panu Hendolin, Ph.D, Director of Research and Development, Biohit Oyj: “In this GPQT validation study, biopsy-confirmed AG was found in 15.3% of the patients. The overall agreement between the GPQT and the USS classification was 71.4%, with the weighted kappa (kw) of 0.823 (ranking almost perfect). In ROC analysis, AUC=0.990 and AUC=0.971 for PGI and PGI/PGII, respectively, in detecting moderate/severe AGC. Hp IgG Ab test detected biopsy-confirmed Hp with AUC=0.836 (13). These data confirm that the DA of the new GPQT favorably competes with the ELISA test version in diagnosis of AG and Hp in patients referred for diagnostic gastroscopy.”
Jussi Hahtela, CEO, Biohit Oyj: “This is the first clinical validation study of GPQT in a cohort of gastroscopy referral patients in a high-risk population in India (13). Being closely concordant with the gastroscopic biopsy results, GPQT offers an outstanding new tool for the POC diagnosis of GC risk conditions (AG and Hp-infection) at one and the same clinical appointment. Apart from its technical excellence, the adoption of GPQT in the clinical management of the patients at high-risk for GC offers several advantages: i) obtains cost savings by reducing unnecessary clinical appointments, ii) speeds up the access of the patients to clinical triage (EGD) when truly indicated, as well as iii) allows more rational allocation of the limited endoscopy resources when unnecessary EGD examinations can be avoided (13,14).
Additional Information:
Panu Hendolin, 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 OMX Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com
References
1. GastroPanel® quick test NT. Available at: https://www.biohithealthcare.com/en/products/gastropanel-quick-test-nt/
2. Biohit HealthCare. GastroPanel®. Available at: https://www.gastropanel.com/healthcare-professionals-and-laboratories/forms-and-instructions (Last access on November 17, 2024)
3. 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, Sung J: Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers. Scand J Gastroenterol 47: 136-147, 2012. DOI: 10.3109/00365521.2011.645501
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 39: 1091-1104, 2019. DOI: 10.21873/anticanres.13218
5. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 74: 74: 229-263, 2024. DOI: 10.3322/caac.21834.
6. Correa P, Haenszel W, Cuello C, Zavala D, Fontham E, Zarama G, Tannenbaum S, Collazos, T Ruiz B: Gastric precancerous process in a high-risk population: cohort follow-up. Cancer Res 50: 4737-4740, 1990. PMID: 2369748
7. Marshall BJ, Warren JR: Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet 1(8390): 1311-1315, 1984. DOI: 10.1016/s0140-6736(84)91816-6.
8. Sipponen P, Marshall BJ: Gastritis and gastric cancer. Western countries. Gastroenterol Clin North Am 29: 579-592, 2000. DOI: 10.1016/s0889-8553(05)70131-x
9. Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O’Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM: European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut Aug 8:gutjnl-2022-327745, 2022. DOI: 10.1136/gutjnl-2022-327745.
10. Syrjänen K: Accuracy of serum biomarker panel (GastroPanel®) in diagnosis of atrophic gastritis of the corpus (AGC). Systematic review and meta-analysis. Anticancer Res 42: 1679-1696, 2022. DOI: 10.21873/anticanres.15645
11. 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 41: 5527-5537, 2021. DOI: 10.21873/anticanres.15366
13. Chabbra, M., Singh, G., Joshi, A., Kolatkar, A., Holopainen, H., Hendolin, P., Syrjänen, K. Point-of-Care Diagnosis of Atrophic Gastritis by Serological Biomarker Test (GastroPanel® quick test) in Gastroscopy Referral Patients in India. J Clin Med. 14, 787-805, 2025.
14. www.biohithealthcare.com/additional-information