Biohit Oyj - Company Announcement

International research groups recommend blood sample biomarker tests for the diagnosis and screening of gastric diseases

Biohit Oyj stock exchange release  June 8 2012 at 2.30 pm

Biohit Oyj has developed the GastroPanel biomarker test, a unique blood sample
examination for the screening and diagnosis of Helicobacter pylori infection
and damage or dysfunction of the mucous membrane (atrophic gastritis) of the
stomach. Unlike the Helicobacter pylori examinations still being used (13C urea
breath test and stool antigen test), the GastroPanel test reliably detects H.
pylori infection,the typically asymptomatic condition atrophic gastritis, and 
associated ¬risks, including cancer (see More information on GastroPanel). 

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 on diseases of the stomach mucosa and the associated risk
conditions. Researchers recommend biomarker tests for the diagnosis of
Helicobacter pylori infection and especially for atrophic gastritis that causes
acid-free stomachs, and  for screening asymptomatic patients. 

The report emphasises the fact that H. pylori eradication therapy does not cure
precancerous gastric conditions. This is why gastroscopy and biopsy examination
are recommended at regular intervals of 2-3 years for patients with moderately
severe or severe atrophic gastritis. Without gastroscopy and biopsy
examination, atrophic gastritis in the entire stomach (precancerous condition)
and its location can only be diagnosed with a GastroPanel biomarker test. 

The international Healthy Stomach Initiative group's 16 gastroenterology
experts from 12 different countries came to the same conclusions. The tests are
suitable for assessing stomach conditions in both asymptomatic patients and
patients with stomach discomfort (www.biohit.fi/Investors/ Stock Exchange
Releases: 17/02/2012 Biohit Oyj's GastroPanel biomarker test recommended). 

According to the taskforce, GastroPanel biomarker tests, unlike the
Helicobacter pylori tests still in use, reliably diagnose the most significant
risk conditions of the acid-free stomach (atrophic gastritis). With the help of
the GastroPanel test, patients can be referred to appropriate further
examinations, therapy and treatment. At the same time it is also possible to
reliably diagnose patients who have a ‘healthy' stomach, i.e. patients who do
not have Helicobacter pylori infection or atrophic gastritis (an acid-free
stomach). 

Carcinogenic acetaldehyde is generated in an acid-free stomach
An IARC (WHO agency on cancer research) classification of October 2009 states
that acetaldehyde in alcoholic beverages and naturally generated in alcohol is
a group 1 carcinogen and is therefore as carcinogenic as Helicobacter pylori,
asbestos, formaldehyde and benzene. 

GastroPanel biomarker tests reliably detect an anacidic stomach which is the
major risk factor of gastric cancer.  Microbes from the mouth can colonise an
acid-free stomach and produce carcinogenic acetaldehyde from sugar and alcohol.
According to gene studies this is one of the major risk factors of gastric and
oesophageal cancer. The risk can be reduced with the help of another Finnish
innovation -  prescription-free Acetium capsules, which are taken during food
and alcohol consumption, to bind (neutralise) carcinogenic acetaldehyde in the
stomach (www.gastropanel.net,
http://www.acetium.com/test-your-acetaldehyde-exposure reveals the acetaldehyde
exposure). 

Contact information:
Semi Korpela, M.Sc. (Econ.), CEO of Biohit Oyj, +358 9 773 861,
semi.korpela@biohit.fi 

Osmo Suovaniemi, MD, PhD, Chairman of the Board of Directors
Biohit Oyj, +358 9 773 861 or +358 40 745 5605, osmo.suovaniemi@biohit.fi


More information on GastroPanel
The state-of-the-art, highly informative, safe and cost-effective GastroPanel
examination for diagnosing dyspepsia and Helicobacter pylori infection does not
involve any of the serious medical and ethical problems described below: 

•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 nearly always asymptomatic,often permanent,
and carries associated risks, including gastric cancer. 

• Atrophic gastritis of the corpus (anacidic 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
system as well as high homocysteine content in the body, which in turn is
thought to be an independent risk factor for atherosclerosis, heart attacks and
strokes. 

• The absorption of dipyridamole, some iron products and antifungals
(fluconazole, itraconazole), thyroxine and atazanavir is considerably impaired
in an anacidic stomach. The risk of pneumonias and, in senior citizens, even
the risk of fatal intestinal infections (such as giardiasis, malaria,
Clostridium difficile and E. coli EHEC) may increase significantly in an
anacidic stomach. 

• 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 is 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 provides any
information on excessive gastric acid secretion, which in patients with
gastro-oesophageal reflux disease may cause complications of this disease. Such
complications are often asymptomatic and include ulcerative oesophagitis and
Barrett's oesophagus, which may lead to oesophageal cancer if left untreated. 

• In addition, the 13C urea breath test and stool antigen test may give up to
40% false negative results 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, it is justifiable and ethically correct to replace the
simple Helicobacter pylori tests with the GastroPanel examination. With the
GastroPanel tests available, treating patients with stomach discomfort with PPI
therapy or even yoghurt, without further diagnosis, can no longer be justified.
Such approaches may delay the diagnosis of, for example, precancerous gastric
lesions until the disease has progressed beyond treatment. Approximately one
third of the population suffers from stomach discomfort. In Finland tens of
thousands of patients among them receive proton pump inhibitor (PPI) treatment
or take prescription free PPI medication regardless of the fact that they
already have an anacidic stomach caused by atrophic gastritis and the
associated risks of cancer and other diseases. Osteoporosis and vitamin B12
deficiency are a major public health problem among the elderly and may
typically be caused by asymptomatic undiagnosed atrophic gastritis. Autoimmune
diseases, such as type 1 diabetes and thyroid diseases, are often related to
autoimmune atrophic gastritis,cancer and other risks associated with the
condition. GastroPanel helps to detect at-risk patients in time and refer them
for gastroscopy and biopsy examination and treatment. 
____________________________________________________
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) 
3.WHO. http://www.iarc.fr/en/media-centre/pr/2009/pdfs/pr196_E.pdf 2011


Information on Biohit Oyj - Biohit HealthCare - Innovating for Health

Biohit Oyj is a Finnish biotechnology company established in 1988. The company
operates in the global market. ‘Innovating for Health' is the Biohit mission.
The purpose of the company is to take social responsibility and produce
innovation, new technologies and analysis systems for use in medicine, research
institutions and industry, helping to promote research and diagnostics and to
improve the quality of life of people by means of preventing disease, human
suffering and financial loss. Our duty is also to innovate and develop the
marketing and availability of our products and services. 
Biohit works with scientific communities to produce new technologies, products
and services based on research results and innovations that can be used to
develop safe and cost-effective diagnostic tests for the early detection and
prevention of diseases of the gastrointestinal tract. (
www.biohithealthcare.com “State of the art GastroPanel and Acetium innovations
for the unmet need” and  “GastroPanel biomarkers: Rationale in diagnosis and
screening of atrophic gastritis with stomach-specific plasma biomarkers”). 
The diagnostics business comprises products and analysis systems for the early
diagnosis and prevention of gastrointestinal diseases, such as the blood-sample
based GastroPanel examinations for the diagnosis of stomach illnesses and
associated risks, quick tests for the diagnosis of lactose intolerance and
Helicobacter pylori infection in connection with gastroscopy, and the ColonView
test for the early detection of intestinal bleeding that indicates a risk of
colorectal cancer. The Acetium innovation reduces the amount of cancer-causing
acetaldehyde in an anacidic stomach.
(http://www.acetium.com/test-your-acetaldehyde-exposure reveals the
acetaldehyde exposure) 
The population is aging and, therefore, the need for safe and cost-effective
diagnosis and prevention of diseases is increasing. General awareness of
carcinogenic acetaldehyde and the associated risks is increasing. This is
expected to substantially increase interest in the company's products and
services. 
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 (www.biohit.fi/Investors).