Published: 2012-06-08 13:30:00 CEST
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.
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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).