Biohit Oyj

Regulatory Filings • Aug 10, 2021

CE marked GastroPanel® quick test on the market

CE marked GastroPanel® quick test on the market

Biohit Oyj stock exchange release 10[th] 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.

ORDERING INFORMATION:

GastroPanel quick test (product number 602320) and GP reader including embedded
interpretation software (product number 602330).

Additional information:
Acting CEO Osmo Suovaniemi, Biohit Oyj
tel. +358 9 773 861

investor.relations@biohit.fi
www.biohithealthcare.com

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 (https://www.globenewswire.com/Tracker?data=ciyb_iZ945H2
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