BIOHIT'S UNIQUE TEST PANEL SUCCESSFUL IN
BIOHIT PLC. STOCK EXCHANGE RELEASE 3.10.2000 AT 14:30 1 (3)
BIOHIT'S UNIQUE TEST PANEL SUCCESSFUL IN CLINICAL EVALUATIONS
Biohit's test panel for screening the risk of gastric cancer and peptic
ulcer from blood samples has successfully passed the extensive clinical
evaluations performed at the Jorvi Hospital in Finland. During the
evaluation 100 patients underwent gastroscopy and the microscopic
examination of the biopsies taken from the mucous membrane of the
stomach. Various types of gastric diseases were diagnosed in approx.
40% of the patients participating in the study. Moreover, the
Pepsinogen I and Gastrin 17 -concentrations and the Helicobacter pylori
(H. pylori) antibodies were determined from blood samples by using
Biohit's test panel. When the results produced by Biohit's test panel
were compared with the diagnoses made on the basis of the gastroscopy
and biopsies, it was found that the sensitivity of the test panel was
over 90%, i.e., the test panel finds nearly all those patients who have
been diagnosed ill on the basis of the results of the gastroscopy and
analysis of the biopsy samples. Furthermore, the test panel was able to
classify correctly, with a specificity of 90%, those patients who did
not suffer from a gastric disease or the disease was mild.
In nearly 90% of the cases the infection of the mucous membrane of the
stomach (gastritis), atrophic gastritis and peptic ulcer is caused by
the H. pylori infection. It has also been observed that the H. pylori
infection is connected with the development of gastric cancer. Approx.
80% of the cases of gastric cancer develops on the basis of the H.
pylori infection. The risk of gastric cancer increases exponentially in
connection with atrophic gastritis, and this risk is approx. 90-fold
for those persons who suffer from severe atrophic gastritis of the
entire stomach compared with persons who have a healthy mucous membrane
of the stomach. In addition to gastric cancer, the H. pylori infection
and the gastritis caused by it, as well as atrophic gastritis make the
patient prone also for peptic ulcer. The risk of peptic ulcer depends
on the severity of the changes caused by the infections and atrophy and
their location in the stomach. Thus, the severity of the underlying
different stomach disorders, which are difficult to diagnose, may vary
from gastritis to gastric cancer. So far, the only useful method of
diagnosing these various conditions has been gastroscopy and the
microscopic examination of the biopsies. Gastroscopy is uncomfortable
for the patient, time-consuming and expensive. Moreover, it is never
performed during the first visit of the patient to the doctor and, in
addition, the resources of specialized doctors are limited for
performing gastroscopies.
In accordance with the consensus recommendation made by experts in a
meeting in Maastricht two weeks ago, a patient suffering from stomach
disorders and the H. pylori infection should be treated with
antibiotics and antacids. The same applies to patients suffering from
atrophic gastritis. Biohit's unique test panel enables any doctor to
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diagnose such diseases fast, reliably and easily without gastroscopy.
The examination made with the test panel prior to treatment ensures a
rapid and accurate diagnosis, and, as a result, renders the treatment
more effective, is more comfortable for the patient and produces cost
savings in health care.
If the results produced by Biohit's test panel require a gastroscopy
and biopsies to be taken, the doctor already knows what kind of a
disease (infection, atrophy or neoplasia) he is looking for and in
which part of the stomach (upper part, i.e., corpus or lower part,
i.e., antrum) it is located. Likewise, it is possible to detect from
the results produced by the test panel whether the possible ulcer is
located in the antrum or the duodenum. The test panel facilitates also
finding such patients whose secretion of acids has increased. Thus, the
results of the tests performed from the blood sample of the patient,
which correlate with the condition of the entire stomach, increase the
reliability of the gastroscopic and biopsy sample examinations, which
are dependent on the experience and skills of the doctor.
Biohit's test panel enables the identification of atrophic gastritis,
which is located in the corpus area of the stomach and leads usually
without any noticeable symptoms to anemia, neurological damages and
increases the risk of dementia. This is caused by the fact that
atrophic gastritis hinders the absorption of vitamin B-12 and
eventually leads to a deficiency of the said vitamin. The deficiency of
vitamin B-12 causes gradually disturbances in cell metabolism, and as a
result, the level of homocysteine of serum increases. A high level of
homocysteine in blood is, on its part, a risk factor for
arteriosclerosis and thrombosis. Biohit's method for determining the
concentration of vitamin B-12 in blood, currently under development,
has received a positive search report concerning the European patent
application covering 16 countries. A Finnish patent has been awarded
for Biohit's test panel for screening the risk of gastric cancer and
peptic ulcer. The objective of Biohit's aggressive patent strategy is
to submit patent applications in all those market areas in which
potential copying of Biohit's products might take place, and in which a
significant amount of the Company's products are sold or are estimated
to be sold, namely certain European countries, Japan, Russia and the
U.S. According to the information received from the National Board of
Patents and Registration in Finland on January 27, 2000 Biohit had at
that stage 16 patents in Finland and the rest of the twenty companies
recently listed in Finland altogether 11 Finnish patents.
The global market potential for Biohit's diagnostic tests has been
estimated to be USD 5,0 billion. Biohit is currently commencing the
marketing of its diagnostic tests through its seven subsidiaries and
numerous distributors, as well as negotiations concerning co-operation
with large multinational diagnostic companies, e.g. in Japan, France
and Canada. In certain Asian and Near Eastern countries Biohit is
negotiating with the representatives of Ministries of Health on the
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deliveries of Biohit's diagnostics test systems to develop the health
care sectors of the said countries. In addition to diagnostic tests,
Biohit is currently able to offer complete diagnostic test systems,
which are comprised of Biohit's liquid handling products, diagnostic
tests, analyzers and related software used for the calculation and
interpretation of the results. These test systems are complemented by
Biohit's maintenance and training services.
In 1999 the net sales of the Biohit Group totalled to MFIM 122,2
million. In January-June 2000 the net sales totalled to MFIM 65,4 (MFIM
61,7 in 1999). The net sales were generated primarily by liquid
handling products and their disposable tips. As a result of the
directed share issue carried out in June 1999, the Company raised
approx. MEUR 9,0 in new capital (2,0 million B-shares, EUR 4,5 / share)
and listed on the New Market (NM) -list of the Helsinki Exchanges. The
closing price of Biohit's share on Oct. 2, 2000 was EUR 7,05. The
overall development of the price of the B-share has been favorable
during the past 12 months demonstrating a growth of 63,57%.
Additional information: Osmo Suovaniemi, President & CEO, tel: +358-9-
773 861, direct: +358-9-773 86 250, mobile:
+358-50 556 5605, fax: +358-9-773 86 205
http://www.biohit.com
Distribution: Helsinki Exchanges
The Financial Supervisory Authority
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