BIOHIT OYJ STOCK EXCHANGE RELEASE 5 JANUARY 2007 AT 16.20
BIOHITS INNOVATIVE GASTROPANEL TO BE USED IN CHINAS HEALTH CARE
SYSTEM
A recent issue of Wei Chang Bing Xue, Chinese Journal of
Gastroenterology; Vol. 11, No. 11, 2006, published a consensus
report of the Chinese scientists recommending the GastroPanel
tests to be used in diagnosing dyspepsia, Helicobacter pylori (H.
pylori) infections and atrophic gastritis.
The recommendation has its origins in the Gastritis Consensus
Workshop which was held in Shanghai on 1516 September 2006. The
workshop was chaired by Professor Shu-Dong Xiao who presides e.g.
at the Chinese Ministry of Health. Sixty seven lecturers and other
participants from different parts of China had been invited to the
working group. The only foreign participants invited were two
leading experts in this field, Professor Pelayo Correa from the
United States (Correas cascade of carcinogenesis) and Professor
Pentti Sipponen from Finland (atrophic gastritis and the risk of
gastric cancer, peptic ulcer and vitamin B12 deficiency). Before
this, the blood sample based GastroPanel tests had already been
granted an import licence to China. In its recommendation, the
working group approved the tests (Gastrin-17, Pepsinogen I and
Pepsinogen II as well as Helicobacter pylori antibodies) for use
in Chinese health care.
In China, approximately two thirds of the population are H. pylori
positive. Almost 50% of those infected with H. pylori may go on to
develop atrophic gastritis and, as a related risk, gastric cancer
which is the second most fatal cancer in China, after lung cancer.
It is likely that the knowledge which Chinese doctors now have
about GastroPanel and the recommendation to use the tests, will
significantly increase GastroPanels demand for determining the
cause of dyspepsia (upper abdominal discomfort or pain), H. pylori
infection, atrophic gastritis (glandular atrophy and subsequent
malfunctioning) and related risks (gastric cancer and peptic
ulcers as well as vitamin B12 deficiency with its associated
risks).
The companys products are marketed in China by Biohits
subsidiary based in Shanghai. On 17 September 2006, Biohit opened
a pipettor production facility in Suzhou.
Biohit Oyj
Osmo Suovaniemi
President & CEO
Further information:
Osmo Suovaniemi, M.D., Ph.D., Professor
President & CEO
Tel: +358-9-773 861
Mobile: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
Distribution:
Helsinki Exchanges
Financial Supervisory Authority
Press
http://www.biohit.com
GastroPanel for the development of safe diagnosis and treatment
praxis for dyspepsia, Helicobacter pylori infection, atrophic
gastritis and related risks
Over half of the global population have a Helicobacter pylori (H.
pylori) infection. In China, approximately two thirds of the
population are affected. Nearly half of those infected will
develop atrophic gastritis with its related risk, e.g. gastric
cancer which in China is the second most fatal cancer.
For a person suffering from dyspepsia (upper abdominal discomfort
or pain) which is found in 2040% of Western population, prior to
any pharmacological treatment or so-called invasive endoscopic
investigations (gastroscopy), the recommended examination should
be a blood-sample-based GastroPanel test (see Tables 1 and 2).
The cause of dyspepsia, especially in the young population, can be
a functional stomach problem or a H. pylori infection and to this
related gastritis (infection of the gastric mucosa) which, over
the years, may progress into atrophic gastritis (glandular atrophy
and the resulting dysfunction). Less common than H. pylori
infection, a mucous stomach membrane destroying autoimmune disease
which can occur in any age group, also induces atrophic gastritis
with related risks. This disease, too, can be detected with a
GastroPanel examination.
Should GastroPanel detect atrophic gastritis, the patient must be
referred to a gastroscopy (an endoscopic examination of the
stomach including biopsy) when it is possible to find a still
treatable, atrophic gastritis induced early gastric cancer or
precancerous lesions.
Using only 13C urea breath test or stool antigen test as
recommended in the test-and-treat strategy, atrophic gastritis
with related risks are not detected (see Table 1). These tests
only give information about H. pylori but not of atrophic
gastritis which up till now has only been possible to detect with
microscopic examination of biopsies taken during gastroscopy.
Furthermore, 13C urea breath test and stool antigen test give up
to 40-50% false negative results, in other words a H. pylori
infection is not diagnosed. This is particularly the case if the
patient has atrophic gastritis, MALT lymphoma (malignant growth of
lymphoid tissue) or bleeding peptic ulcer disease or if the
patient is currently receiving antibiotics or PPI medication
(proton pump inhibitors). These tests which are still in general
use in Finland give false negative results just when the patient
needs reliable detection of H. pylori infection and atrophic
gastritis with its associated risks.
In addition to the risk of gastric cancer, mildly symptomatic or
most often completely asymptomatic atrophic gastritis is also
associated with the risk of peptic ulcer disease and Vitamin B12
deficiency. Vitamin B12 deficiency may increase the risk of, e.g.
dementia, depression and damage to the peripheral nervous system
(www.b12.com ). Vitamin B12 deficiency, which is fast becoming a
disease of public importance as the global population ages, also
affects an increase of the level of homocysteine in the body,
which in turn is a possible independent risk factor for
atherosclerosis as well as heart attacks and strokes
(www.homocysteine.com / see e.g. Geography).
The GastroPanel examination (www.gastropanel.net) detects H.
pylori infection and atrophic gastritis and related risks, and it
identifies patients who are at the highest risk of severe
complications associated with gastroesophageal reflux disease.
These include erosive esophagitis and so-called Barrett´s
esophagus which can be asymptomatic and over time, unless treated,
they can even progress into esophageal cancer.
Up till now, gastroesophageal reflux disease has been treated with
proton pump inhibitors (PPI) and has even been diagnosed with PPI
test treatment. Prior to treatment initiation, GastroPanel
examination should be used in order to establish that the
patient´s stomach is not already achlorhydric due to atrophic
gastritis of the corpus of the stomach. A patient, whose stomach
does not excrete acid (HCI), does not derive any benefit from
expensive proton pump inhibitors (PPI). Needless PPI therapy can
fatally delay detection and treatment of an early stage gastric
cancer.
Biohits innovative GastroPanel is associated with the Nobel Prize
for Medicine 2005 which was received by the Australian doctors
Robin Warren and Barry Marshall for the discovery of Helicobacter
pylori. In their first publications they already had put forward
that Helicobacter infection progresses into atrophic gastritis and
it is an important factor in the development of peptic ulcers.
Both have been involved in basic research associated with
GastroPanel. Professor Marshall values highly the pioneering work
of Professor Max Siuralas Finnish-Estonian team and that of
Professor Pentti Sipponen. It was partly this work which showed
the way for him and Professor Robin Warren in 1982 to make a
discovery which became worthy of the Nobel Prize
(http://nobelprize.org/medicine/laureates/2005/press.html ).
The GastroPanel invention complements the achievements of the
Nobel Prize winners and makes it possible to put todays knowledge
about H. pylori and atrophic gastritis into more effective use in
practical medicine. Naturally Professor Marshall hopes that, as
this work continues, its results will be used to develop medicine
and treatments in Finland, too. Barry Marshall was awarded the Max
Siurala Prize at the gastroenterologists anniversary meeting
(50th anniversary meeting of the Finnish Society of
Gastroenterology on 78 September 2006 in Turku. The theme was:
Gastroenterological Achievements and Visions for the Future).
Global evaluations, approvals and increasing use of GastroPanel
Over recent years, the applicability of GastroPanel has been
studied in approximately 40,000 patients in different parts of the
world. GastroPanel has been granted marketing authorizations for
clinical use in all EU countries, India, Canada, China, Ukraine
and Russia, among others. The FDA approval application and the
additional studies on American patient populations required for it
are underway in the USA. A similar procedure for marketing
authorization in Japan is also being carried out. GastroPanel is
currently being introduced in the primary diagnosis of dyspepsia
as well as H. pylori and atrophic gastritis in different parts of
the world. Many service laboratories carry out GastroPanel
examinations. The worlds largest service laboratory, the US-based
Quest Diagnostics, introduced GastroPanel in its UK programme more
than a year ago.
Professor Francesco DiMario and his colleagues have written a
GastroPanel manual that was distributed by the worlds leading PPI
company to 35,000 general practitioners in Italy. The purpose of
the manual is to provide more rapidly a more exact diagnosis for
patients with dyspepsia-type complaints and possible H. pylori
infection, atrophic gastritis and gastroesophageal reflux disease
with the use of GastroPanel. The GastroPanel examination together
with the patients medical history and clinical examination
results will result in the patient being referred for any further
examinations on the right grounds, finally resulting in an
accurate diagnosis and the right treatment (Suovaniemi O.
GastroPanel dyspepsian, helikobakteeri-infektion ja atrofisen
gastriitin ja siihen liittyvien riskien turvallisen tutkimus- ja
hoitokäytännön kehittämiseen, Erillispainos Yksityislääkäri 2006;
5. (In English), www.biohit.fi / Yritys / Kirjallisuus / Articles
in Newspapers and www.biohit.com / Diagnostics / Literature).
In Finland, the Social Insurance Institution (KELA) reimburses
approximately EUR 67 of the cost of GastroPanel tests prescribed
by a doctor. Commercial service laboratories charge EUR 120 EUR
140 in all for GastroPanel tests (Pepsinogen I and Pepsinogen II,
Gastrin-17 and Helicobacter pylori antibodies). If a Biohit
service laboratory determines GastroPanel test results, it charges
the health centre and the hospital a total of EUR 70 for the
GastroPanel tests and GastroSoft report (www.gastropanel.net /
GastroSoft) (www.biohit.fi / Palvelulaboratorio).
Table 1. Summary of the data provided by the GastroPanel
examination and the 13C urea breath test or stool antigen test of
the test and treat strategy. The report from the GastroPanel
test results produced by the GastroSoft are based on clinical
studies comparing the results of GastroPanel examinations with
results from gastroscopy and biopsy specimen examinations
(www.biohit.com/gastrosoft).
The serious medical and ethical problems of the test and treat
strategy can be corrected simply and economically by replacing its
13C urea breath test or stool antigen test by the GastroPanel
examination (www.gastropanel.net, www.biohit.com / Diagnostics /
Literature).
Based on the 13C urea breath
GastroPanel test or Stool
test results antigen test
the GastroSoft report states:
report states:
The diagnosis for
Functional vs. organic YES NO
dyspepsia.
When GastroPanel indicates that
the gastric mucosa is healthy,
the dyspepsia complaints are
often caused by functional
dyspepsia or another disease
not involving the gastric
mucosa
H. pylori infection (gastritis) YES NOT RELIABLE (1)
Atrophic gastritis YES NO
Atrophied and severely
dysfunctional gastric mucosa of
the gastric corpus or antrum or
both
The risks (caused by atrophic
gastritis) of
Gastric cancer YES YES/NO (2)
Vitamin B12 deficiency YES NO
Peptic ulcer disease YES YES/NO (3)
The risks of the complications
of gastroesophageal reflux
disease:
Esophagitis and Barretts
esophagus YES (4) NO
If necessary, a recommendation
for
Gastroscopy and biopsy
examination YES NO
Treatment of H. pylori
infection YES YES/NO (5)
Determination of Vitamin B12
and homocysteine YES NO
Follow-up examination to
monitor
the incidence of atrophic
gastritis YES NO
the healing of the H. pylori
infection YES YES
the healing of atrophic
gastritis YES NO
(1) The 13C urea breath and stool antigen tests give 4050% false
negative results if the patient has a) atrophic gastritis; b) MALT
lymphoma; or c) bleeding peptic ulcer disease; or d) if the
patient is currently receiving antibiotics or PPIs (proton pump
inhibitors).
(2) The risk of gastric cancer is very low without atrophic
gastritis in corpus, antrum or both. But in some cases, a H.
pylori infection without histologically observable atrophic
gastritis may be associated with gastric cancer and peptic ulcer
disease.
(3) No peptic ulcer disease with corpus atrophy (no acid, no
ulcer). The risk of peptic ulcer disease is very low without
antrum atrophy. - Increased level of Pepsinogen II (over 10 µg /l)
may indicate the use of non-steroidal anti-inflammatory drugs
(e.g. aspirin) or strong alcohol.
(4) High Pepsinogen I (over 120 µg /l) and high Pepsinogen I and
II ratio (over 10) and low Gastrin-17 (below 2 pmol /l) indicate
high acid (HCl) output and risks for the complications of
gastroesophageal reflux disease.
(5) When the incidence of H. pylori related atrophic gastritis is
monitored, the patient can be offered targeted, safe treatment at
the right time. The need for medication and the costs and adverse
effects of medication can thus be reduced. If the patient has been
diagnosed with peptic ulcer disease (gastric or duodenal ulcer),
the H. pylori infection has to be treated (6). H. pylori infection
has also to be treated and a patient examined by gastroscopy if
the patient has atrophic gastritis. The patient and the doctor may
also agree on H. pylori infection treatment for other reasons, for
example, when the patients close relatives have been diagnosed
with gastric cancer.
(6) Press Release: The 2005 Nobel Prize in Physiology or Medicine,
3 October 2005 jointly to Barry Marshall and J. Robin Warren for
their discovery of the bacterium Helicobacter pylori and its role
in gastritis and peptic ulcer disease: - An indiscriminate use
of antibiotics to eradicate Helicobacter pylori also from healthy
carriers would lead to severe problems with bacterial resistance
against these important drugs. Therefore, treatment against
Helicobacter pylori should be used restrictively in patients
without documented gastric or duodenal ulcer disease.
http://nobelprize.org/medicine/laureates/2005/press.html
Table 2. The GastroPanel examination consists of various
biomarkers measured in blood. These biomarkers are pepsinogen I
and pepsinogen II, gastrin-17 and Helicobacter pylori IgA and IgG
antibodies. The healthy gastric mucosa produces acid (HCl),
pepsinogen I (PG I) and pepsinogen II (PG II) from the corpus of
the stomach and gastrin-17 (G-17) and pepsinogen II from the
antrum of the stomach. Helicobacter pylori bacteria in the stomach
mucosa induce the production of Helicobacter pylori antibodies.
Biomarker Indications
Pepsinogen I The lower the PGI concentration, the more
severe the corpus atrophy and related risks
(gastric cancer and Vitamin B12 deficiency
Pepsinogen I / The lower the PGI/PGII ratio, the more severe
Pepsinogen II the corpus atrophy and related risks
Gastrin-17 The lower the Gastrin-17 concentration, the
more severe the antrum atrophy and related
risks (gastric cancer and peptic ulcer
disease)
H. pylori H. pylori infection which may lead to
antibodies atrophic gastritis and related risks.