CE marked GastroPanel® quick test on the market
Biohit Oyj stock exchange release 10th of August 2021 at 04.15 pm local time (EET)
The latest innovation in the unique Biohit GastroPanel product family, GastroPanel quick test, is now CE marked.
GastroPanel quick test is intended for diagnosing Helicobacter pylori infection and atrophic gastritis from patients with dyspeptic symptoms. The test measures pepsinogen I, pepsinogen II, gastrin-17 and antibodies against Helicobacter pylori from a human plasma sample in one test. Test also identifies persons at risk to develop malignant cellular changes in stomach mucosa or who necessitate additional stomach examination or treatment. Test results are available in 20 minutes, allowing fast diagnosis and screening for further examinations.
GastroPanel quick test system comprises of an immunological test and dedicated GP Reader device which interprets the result. The clinical performance of the GastroPanel quick test system is in line with the on market available and previously validated ELISA-based GastroPanel® test.
Samples collected from 500 patients with upper abdominal symptoms at Oulu University Hospital in 2016-2020 were tested with GastroPanel quick test. The results were compared with gastric endoscopies and biopsies performed according to international guidelines. The concordance between the methods was demonstrated to be excellent.
We are excited to launch the GastroPanel quick test system with such excellent performance characteristics and fast turnaround time. We believe that the test system will be well received by end users because the usability of the test system enables first-line diagnosis and screening of dyspeptic patients easier than ever before. We are eager to continue developing the testing system further. Next, we will extend the CE mark of the GastroPanel quick test to include finger-prick blood samples by the end of 2021.
GastroPanel quick test (product number 602320) and GP reader including embedded interpretation software (product number 602330).
Acting CEO Osmo Suovaniemi, Biohit Oyj
tel. +358 9 773 861
Biohit in brief
Biohit Oyj is a globally operating Finnish biotechnology company. Biohit 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 Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com