Study confirms accuracy of new generation GastroPanel test
25 Mar 2022
A clinical validation study conducted at Oulu University Hospital (OUH) has confirmed the high accuracy of BIOHIT Oyj’s new generation GastroPanel test for the diagnosis of atrophic gastritis (AG) and Helicobacter pylori (Hp) infection in patients referred for gastroscopy.
The blood test is designed for first-line diagnosis of Hp infection and AG in patients with upper abdominal symptoms, such as dyspepsia and gastro-oesophageal reflux disease (GORD), before endoscopy and can monitor the regulatory mechanism of acid output in the stomach.
Hp infection, AG and high acid output are important risk factors for gastric and oesophageal cancers. The new GastroPanel test works on the same principle as the original GastroPanel ELISA test and is designed to harmonise the ELISA processing conditions of four biomarkers. It is a cost-effective solution for population-based screening for the risk of gastric cancer in asymptomatic and symptomatic individuals, with its efficacy already confirmed by studies in both high- and low-risk countries.
This latest study evaluated the diagnostic accuracy of the new generation GastroPanel test for the diagnosis of both AG and Hp infection in patients referred for gastroscopy from Primary Care with different indications. As with previously published clinical validation research, the biopsy-confirmed study was designed to verify the diagnostic capabilities of the new generation test compared to the current gold standard (gastroscopy and biopsy analysis), and to demonstrate its performance was comparable to the original GastroPanel test. The positive results also pave the way for BIOHIT’s GastroPanel Quick Test (point of care test).
Dr. Olli-Pekka Koivurova, Principal Investigator of the study at OUH, saidd: “A total of 522 patients referred for gastroscopy at the Gastro Centre, OUH, were consented and enrolled for this particular study. Blood was sampled for all patients using the GastroPanel test, along with performing quality-controlled gastroscopies with mucosal biopsies. The results confirmed that the new generation GastroPanel is a highly accurate test for the non-invasive diagnosis of AG and Hp infection in patients referred for diagnostic gastroscopies.”