Biohit Oyj has been granted a methods patent related to GastroPanel in China
Biohit Oyj has been granted a methods patent related to GastroPanel in China
Main Market, 2012-09-25 17:00 CEST (GLOBE NEWSWIRE) -- Biohit Oyj, stock
exchange release, 25.9.2012, EET 18:00
Biohit Oyj was recently granted a patent protecting the GastroPanel invention
in China. The patent will protect “the method for diagnosing atrophic
gastritis” and is in effect until 3 January 2022. Patents relating to the
GastroPanel invention have also been applied and granted in Europe, Japan and
the United States.
GastroPanel is a unique examination that is carried out as a blood sample test
based on biomarker tests. It has been designed for the early diagnosis and
screening of possible Helicobacter pylori infections or atrophic gastritis in
patients suffering from stomach discomfort as well as asymptomatic people
(www.gastropanel.fi). Over half of the world’s population suffers from
Helicobacter pylori infections, and it has been estimated that approximately
500 million people have atrophic gastritis. In China, approximately two in
three of the entire population suffer from a Helicobacter pylori infection.
Helicobacter pylori infection and atrophic gastritis can lead to gastric
cancer, which is one of the most fatal cancers in China. It is possible to
significantly improve the prognosis of Helicobacter pylori infections and
atrophic gastritis as well as the early stages of cancer advancing from those
diseases with early diagnosis that enables treatment of the diseases. CanAg
Diagnostic (Beijing), a Chinese affiliate of the Japanese company, Fujirebio,
has started the marketing and sales of GastroPanel tests in China. CanAg
Diagnostics has approximately 200 retailers in China.
Anacidic stomach caused by atrophic gastritis is the most well-known risk
factor of gastric and oesophageal cancer. In addition, an anacidic stomach can
lead to malabsorption of vitamin B12, iron, magnesium, calcium and certain
drugs. The risk of gastric and oesophageal cancer caused by an anacidic stomach
can be decreased with unique Acetium capsules that have been developed by
Biohit Oyj. The capsules efficiently bind (neutralise) carcinogenic
acetaldehyde formed in an anacidic stomach (see Additional information).
Semi Korpela, CEO and President
Tel. +358 9 773 86 333
Diseases of the gastrointestinal tract are a major cause of high healthcare
costs globally, and the costs are growing uncontrollably. Due to late
diagnosis, the treatment practices of many cancers – particularly cancers of
the gastrointestinal tract – are inadequate. Many patients either do not
receive safe, effective treatment or are dissatisfied with the treatment they
get. The ageing of the population is leading to an increase in gastrointestinal
cancers as well as vitamin B12 and calcium deficiency resulting from an
achlorhydric stomach. In addition, more diseases are caused by these
deficiencies. This puts a rapidly growing burden on well-being and national
health and reduces people’s ability to remain in longer-term employment.
In Finland, approximately 940 people are diagnosed with oesophageal and stomach
cancer every year, and 730 people die from these diseases. At an early and
curable stage, these cancers are often asymptomatic or involve minor symptoms.
That is why these cancers are too often treated for too long with
self-medication, such as the widely advertised medications decreasing gastric
acid secretion or different dietary supplements. Patients are therefore left
without diagnosis and thus do not receive treatment. The prognosis of these
cancers is especially poor due to late diagnosis. It is possible to
significantly improve the prognosis of atrophic gastritis as well as the early
stages of cancer as a result with early diagnosis thereby enabling treatment of
GastroPanel reliably detects H. pylori infection, as well as atrophy of the
gastric mucosa and dysfunction of the stomach (atrophic gastritis) that are
caused by H. pylori infection or by an autoimmune disease, which, in turn,
leads to achlorhydric stomach. Mouth bacteria and yeasts are transmitted via
swallowing saliva, and they can persist and produce carcinogenic acetaldehyde
from the sugars found in food and alcohol in the achlorhydric stomach.
The 13C urea breath test, stool antigen tests and antibody tests extensively
used to diagnose various abdominal complaints (dyspepsia) do not detect
atrophic gastritis (achlorhydric stomach), which is the major risk factor for
gastric and oesophageal cancer.
Based on the results of the Finnish Setti study, it has been estimated that
the treatment and prognosis of stomach cancer among patients aged over 45 could
be significantly improved in Finland by using the GastroPanel test as the
primary examination for patients with abdominal complaints, and for screening
and regular checkups for anyone aged over 45. This would allow the referral of
at-risk patients for gastroscopy examinations in time to enable cancers to be
detected at an early stage. Regular checkups offer a wealth of reliable and
valuable information that may be relevant for the patient's future health and
quality of life.
If the patient has developed severe atrophic gastritis, the condition is
typically permanent, and the patient will require follow-up tests due to the
risk of cancer. These patients can reduce their risk of developing gastric and
oesophageal cancer by taking Acetium capsules.
Measures to reduce the risk of gastric and oesophageal cancer include the
GastroPanel test and the use of Acetium capsules which, when taken in
connection with food and alcohol intake, effectively bind (neutralise)
carcinogenic acetaldehyde in the stomach.
Acetium capsules, which are available in pharmacies without prescription, are
recommended to those with
1. an achlorhydric or low-acid stomach caused by atrophic gastritis resulting
from Helicobacter pylori infection or an autoimmune disease, which can be
diagnosed with GastroPanel (500 million worldwide),
2. an untreated chronic Helicobacter pylori infection, which can be reliably
diagnosed with GastroPanel (more than 500 million people worldwide),
3. the long-term need to use medications that reduce gastric acid (HCl)
secretion (PPI medication and H2 blockers); approximately 5-10% of Western
population use these occasionally or regularly, and possibly more than 500,000
people in Finland,
4. people who have undergone stomach surgery (over a million people worldwide),
5. people with the gene mutation that affects acetaldehyde metabolism: 30–50%
of Asians show ALDH2 deficiency.
Although data on the effectiveness of Acetium in the prevention of gastric and
oesophageal cancer is not yet available, there is conclusive scientific
evidence to suggest that acetaldehyde, a group I carcinogen, causes cancer, and
that acetaldehyde is generated in an achlorhydric stomach, which is a known
risk factor for gastric and oesophageal cancer. Exposure to acetaldehyde is
linked to more than three million new gastrointestinal cancers per year
globally, which represents approximately 25 per cent of all cancers (visit
www.acetium.com to test your exposure to acetaldehyde).
Acetium has been granted a wide patent protection in Europe. Patents are also
pending outside Europe (www.biohithealthcare.com: Investors/ Stock Exchange
Releases: 20/07/2012: European Patent Awarded to Biohit Oyj’s Acetium).
IARC, the WHO’s agency on cancer research, declared in October 2009 that the
acetaldehyde in alcoholic beverages and naturally generated in alcohol is a
group 1 carcinogen and therefore as carcinogenic as asbestos, formaldehyde and
International research groups recommend blood sample biomarker tests for the
diagnosis and screening of gastric diseases (Investors/ Stock Exchange
Unlike the Helicobacter pylori examinations still being used (13C urea breath
test and stool antigen test), the GastroPanel biomarker test reliably detects
H. pylori infection, the typically asymptomatic condition atrophic gastritis,
and associated risks, including cancer.
As much as 20-40% of the Western population suffers from dyspepsia, which,
according to conventional medical practice, requires gastroscopy. There are no
resources available, nor is there any need for such examinations or high-risk
experimental medications. The GastroPanel biomarker test allows only ill and
at-risk patients to be referred for gastroscopy and treatment. This increases
patient safety, and saves 40-70% of scarce and expensive endoscopy capacity to
be used for colonoscopies for early diagnosis and prevention of colorectal
cancer. Particularly with elderly people, problems in the colon are often the
cause of dyspepsia complaints. It is therefore advisable to supplement
GastroPanel with a ColonView test to select at-risk patients for colonoscopy
(www.biohithealthcare.com: Diagnostics / Product brochures).
The April 2012 Maastricht IV consensus report of the European Helicobacter
Pylori Study Group recommends blood sample biomarker tests as a reliable method
of diagnosis of diseases of the stomach mucosa and associated risk conditions.
Researchers recommend biomarker tests for the diagnosis and follow-up of
Helicobacter pylori infection and especially for atrophic gastritis that causes
achlorhydric stomachs, in addition to recommending the screening of
The international Healthy Stomach Initiative group’s 16 gastroenterology
experts from 12 countries (www.hsinitiative.org) came to the same conclusions.
Biomarker tests can be used to diagnose and screen atrophic gastritis and
related risks in both asymptomatic patients and patients with abdominal
discomfort (www.biohithealthcare.com: Investors/ Stock Exchange Releases:
17/02/2012 Biohit Oyj’s GastroPanel biomarker test recommended).
The state-of-the-art, highly informative, safe and cost-effective GastroPanel
biomarker test for diagnosing dyspepsia (various upper abdominal complaints)
and Helicobacter pylori infection does not involve any of the problems
•The 13C urea breath test (UBT), stool antigen test and antibody tests alone do
not detect atrophic gastritis of the corpus caused by H. pylori infection or
autoimmune disease, or atrophic gastritis of the antrum caused by H. pylori
infection. Atrophic gastritis is almost always asymptomatic and usually
• Undiagnosed atrophic gastritis of the corpus (achlorhydric stomach) may cause
gastric and oesophageal cancer and malabsorption of vitamin B12, iron,
magnesium, calcium and certain drugs.
• Calcium deficiency causes osteoporosis. Vitamin B12 deficiency can cause
pernicious anaemia, dementia, depression and damage to the peripheral nervous
• The absorption of several drugs such as dipyridamole, some iron products and
antifungals (fluconazole, itraconazole), thyroxine and atazanavir is
considerably impaired in an achlorhydric stomach. Particularly in senior
citizens, the risk of severe intestinal infections (such as giardiasis,
malaria, Clostridium difficile and E. coli EHEC) increases.
• Atrophic gastritis in the gastric antrum increases the risk of peptic ulcer
disease and gastric cancer. If both the antrum and corpus mucosa are atrophic,
this condition poses the highest risk for gastric cancer known to date. In some
cases, gastric cancer is directly caused by H. pylori and gastritis. Less than
1% of the population has hereditary gastric cancer.
• Furthermore, none of the aforementioned three H. pylori tests provide any
information on excessive gastric acid secretion, which in patients with
gastro-oesophageal reflux disease may cause complications from this disease.
Such complications are often asymptomatic and include ulcerative oesophagitis
and Barrett’s oesophagus, which may lead to oesophageal cancer if left
untreated. If complications of the gastroesophageal reflux disease are
suspected due to excessive acid secretion, or if the patient has atrophic
gastritis or symptomatic Helicobacter pylori infection, gastroscopy is required
to rule out cancer and other risks.
• In addition, the 13C urea breath test and stool antigen test may give up to
40% false negative results: in other words, the infection including cancer and
other risks may be left undiagnosed if the patient has atrophic gastritis, MALT
lymphoma or bleeding peptic ulcer disease, or if the patient is currently
receiving antibiotics or PPI treatment.
In order to prevent medical malpractice, unnecessary costs and even unnecessary
deaths caused by cancer, the current Helicobacter pylori tests should be
replaced by the GastroPanel biomarker examination. With the GastroPanel tests
readily available, treating patients suffering from stomach discomfort without
further diagnosis can no longer be justified. Risky self-treatment of stomach
discomforts may delay the diagnosis of, for example, precancerous gastric
lesions until the disease has progressed beyond treatment. Approximately
one-third of the population in Finland suffer from stomach discomfort. Tens of
thousands of patients from this group receive proton pump inhibitor (PPI)
treatment or take prescription-free PPI medication, regardless of the fact that
they already have an achlorhydric stomach caused by atrophic gastritis and the
associated risks of cancer and other diseases.
Proton pump inhibitor (PPI) medications, both prescribed and those available
without prescription, come with the following warning: ”If the patient has
alarming symptoms (e.g. significant unintentional weight loss, persistent
continuous vomiting, difficulty swallowing, blood in vomit or in stool) and a
suspected or diagnosed peptic ulcer, any malignant conditions must be ruled out
because PPI treatment can alleviate the symptoms and delay diagnosis.” This
warning is justified but insufficient to lower the extremely high mortality
rate in patients with stomach and oesophageal cancer. When “alarming symptoms”
have appeared, the cancer has usually advanced to a non-curable stage. Despite
this warning and without ruling out atrophic gastritis (achlorhydric stomach),
stomach discomfort is very often treated with PPI and other medications that
reduce gastric acid (HCl). Furthermore, atrophic gastritis and the associated
cancer risk caused by both a Helicobacter pylori infection and an autoimmune
disease typically cause few or no symptoms.
Osteoporosis and vitamin B12 deficiency represent a major public health problem
among the elderly, and may typically be caused by asymptomatic undiagnosed
atrophic gastritis. A person with an autoimmune atrophic gastritis of the
corpus may simultaneously suffer from an another autoimmune disease, such as
thyroiditis, celiac disease, rheumatoid arthritis and type 1 diabetes; or vice
versa, a person with thyroiditis and type 1 diabetes often suffers from
autoimmune asymptomatic atrophic gastritis and the resulting risk of gastric
and oesophageal cancer as well as vitamin B12 deficiency. GastroPanel helps to
detect at-risk patients in time and refer them to gastroscopy and treatment.
Literature on GastroPanel
1.Malfertheiner et al. Management of Helicobacter pylori infection. The
Maastricht IV/ Florence Consensus Report. gut-bmj.com on May 18, 2012. European
Helicobacter Pylori Study Group, ESPSG
2.Agreus et al. Rationale in diagnosis and screening of atrophic gastritis with
stomach-specific plasma biomarkers, Scandinavian Journal of Gastroenterology
2012; 47: 136 – 147)
Literature on Acetium and acetaldehyde
1. Salaspuro V, Hietala J, Kaihovaara P, Pihlajarinne H, Marvola M, Salaspuro
M. Removal of acetaldehyde from saliva by a slow-release buccal tablet of
L-cysteine. Int J Cancer 2002; 97:361-4.
3. Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating carcinogenic
acetaldehyde by cysteine from saliva during smoking. Cancer Epid Biomark Prev
4. Kartal A, Hietala J, Laakso I, Kaihovaara P, Salaspuro V, Sakkinen M, et al.
Formulation and in vivo evaluation of L-cysteine chewing gums for binding
carcinogenic acetaldehyde in the saliva during smoking. J Pharm Pharmacol.
5. Linderborg K, Marvola T, Marvola M, Salaspuro M, Färkkilä M, Väkeväinen S.
Reducing carcinogenic acetaldehyde exposure in the achlorhydric stomach with
cysteine. Alcoholicm Clin Exp Res, 2011;35:1-7.
Biohit is headquartered in Helsinki and its subsidiary is located in the UK.
Since 1999, Biohit’s Series B shares (BIOBV) have been listed in the NASDAQ OMX
Helsinki Oy Small cap/Healthcare sector