Biohit receives SFDA clearance for GastroPanel and establishes a
BIOHIT OYJ STOCK EXCHANGE RELEASE 29 JULY 2005
Biohit receives SFDA clearance for GastroPanel and establishes a
sales channel in China
Chinas State Food and Drug Administration (SFDA) has cleared the
pepsinogen I, pepsinogen II, and gastrin-17 test kits of the
GastroPanel examination developed and manufactured by Biohit. This
enables Biohit to sell the GastroPanel tests in China.
Moreover, Biohit has made an agreement with Da An Gene Co. Ltd. of
Zhong Shan University (www.daangene.com) for marketing and sales
of GastroPanel in China. Da An Gene is the second largest
organisation for development and sales of diagnostics products in
China. The sales network of Da An Gene covers the whole country.
China is the worlds second fastest growing in vitro diagnostics
(IVD) market with an average annual growth rate of 16%.
Biohits in vitro diagnostics comply with EU standards and
regulations, thus allowing marketing and distribution of all
diagnostics products in the EU. GastroPanel has already been
cleared for marketing and distribution in India, Canada and
Russia. The GastroPanel test kits, pepsinogen I and II are still
being evaluated by the US FDA. In Japan the clinical research
needed for clearance is in progress.
A total of 23 evaluations (with approx 17,000 patients) and
clinical research utilising GastroPanel have been conducted, and
another 35 studies comprising 35,000 patients are still ongoing in
Europe, North America and Asia.
About GastroPanel
The GastroPanel examination consists of four biomarkers:
pepsinogen I and II, gastrin-17 and Helicobacter pylori
antibodies, measured in blood. With GastroSoft software for the
interpretation of results, this unique and patented diagnostic
test panel has been developed as a primary and follow-up
examination in the diagnosis and treatment of people with
dyspepsia-type complaints, Helicobacter pylori infection and
atrophic gastritis.
If the GastroPanel examination gives a normal result,
the diagnosis is either functional dyspepsia (stomach mucosa is
healthy) or another disease not involving the stomach mucosa. The
GastroPanel examination also diagnoses Helicobacter pylori
infection, atrophic gastritis and its location (corpus, antrum or
both). In addition to these diagnoses, the interpretive software
also warns of the risks associated with atrophic gastritis of the
corpus of the stomach, which include gastric cancer and vitamin
B12 deficiency, and of the risks associated with atrophic
gastritis of the antrum, which include peptic ulcer disease and
gastric cancer. The GastroSoft report also indicates the risk of
gastroesophageal reflux disease. If necessary, the report
recommends further examinations, such as gastroscopy and biopsy
specimen examination as well as vitamin B12 and homocysteine
determinations.
Until now, diagnosing the diseases of the stomach mucosa has only
been possible through Helicobacter pylori tests and trial
medication (the "test-and-treat" method) and limited endoscopic
resources. The test-and-treat method does not find atrophic
gastritis and related risks, such as precancerous lesions and
early gastric cancer, which in most cases could be successfully
treated. The diagnosis and treatment of dyspepsia, which are based
on the test-and-treat method and often only on symptoms reported
by the patient and good guesses made by the doctor, do not follow
safe and ethical guidelines of evidence-based medicine.
In the light of current research data, the GastroPanel examination
promotes evidence-based medicine as follows:
1) In the diagnosis and treatment of functional and organic
dyspepsia, Helicobacter pylori infection, atrophic gastritis and
the associated risks (gastric cancer, peptic ulcer and vitamin B12
deficiency).
2) In monitoring the success of treatment for Helicobacter pylori
infection and atrophic gastritis.
3) In monitoring the status of mildly symptomatic or often
asymptomatic atrophic gastritis and the related risks associated
with Helicobacter pylori infections and autoimmune disease. Such
monitoring could promote targeted, safe treatment and decrease the
costs and adverse effects of medication. If the patient has not
been diagnosed with peptic ulcer disease or being at risk of
peptic ulcer, the Helicobacter pylori infection would only need to
be treated if the patient is developing atrophic gastritis or the
patient and doctor agree on eradication treatment for other
reasons.
4) In assessing the risk of gastroesophageal reflux disease.
Carcinomas of stomach are thought to arise from a series of
changes within the gastric mucosa progressing through atrophic
gastritis, intestinal metaplasia, and dysplasia to malignancy.
Atrophic gastritis may heal on long-term follow-up after
Helicobacter pylori eradication, which is thus strongly
recommended in atrophic gastritis, but intestinal metaplasia may
not be reversible.
Consequently, the diagnosis of Helicobacter pylori infection and
its treatment alone (i.e., the test-and-treat method), without the
diagnosis of atrophic gastritis and related risks (e.g., early
gastric cancer or precancerous lesions), does not present a safe
and ethical treatment for dyspepsia, Helicobacter pylori infection
and related early gastric cancer or precancerous lesions. This
serious medical problem can be simply and economically solved by
using the GastroPanel examination as the diagnostic test of
choice in the test-and-treat method.
If atrophic gastritis and related risks are found by the
GastroPanel examination, the patient must be referred for a
careful gastroscopy and biopsy specimen examination, where the
GastroPanel data is very useful. Based on the Finnish Setti study
of 23,000 male smokers aged 50-65 years, it has been estimated
that the GastroPanel screening of atrophic gastritis and the
related risk of gastric cancer and precancerous lesions may
prevent 200300 gastric cancer deaths annually among persons over
50 in Finland, where the population is 5.25 million.
In Finland the number of gastric cancer cases is decreasing and
less than 1000 new cases are diagnosed annually. On the contrary,
the incidence of gastric cancer, e.g., in Japan, China and Russia
is considerably higher than in Finland, and for example in China
is the number one cancer killer. Although the number of gastric
cancer cases in Finland is decreasing, globally the emergence of
gastric cancer is increasing in line with the increase of the
average lifespan. Gastric cancer is mainly the disease of elderly
population new cases appear more as the population ages.
Biohit Oyj
Osmo Suovaniemi
President & CEO
Further information:
Osmo Suovaniemi, M.D., Ph.D.
Professor
President & CEO
Tel: 09-773 861
GSM: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
http://www.biohit.com
Distribution:
Helsinki Exchanges
Financial Supervisory Authority
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