PRODUCT CATALOGUE 2013

Transcription

1 PRODUCT CATALOGUE 2013 Stomach health tests Other ELISA tests Quick tests Monoclonal antibodies Acetaldehyde binding products Service laboratory

2 Contents About Biohit 3 GastroPanel 4-7 GastroPanel 4 GastroPanel Report 6 GastroPanel Laboratory 7Gas Other ELISA tests 8-11 Celiac Disease Panel 9 Inflammatory Bowel Disease (IBD) Panel 10 Cellular Fibronectin Test 10 Systemic Lupus Erythematosus (SLE) Test 11 Quick Tests Lactose Intorelance quick test 13 Helicobacter Pylori quick test 14 Fecal Occult Blood Tests 15 Celiac quick test 15 Monoclonal Antibodies Acetaldehyde binding products Instruments & Service Laboratory Collaboration and partnering opportunities 22 References 22-23

3 Biohit in Brief Biohit Oyj is a globally operating Finnish biotechnology company established in Biohit s range comprises products and analysis systems for the prevention and early diagnosis of gastrointestinal diseases. These include the blood samplebased GastroPanel examinations for the diagnosis of stomach diseases and associated risks, including gastric cancer; quick tests for the diagnosis of lactose intolerance and Helicobacter pylori infection in connection with gastroscopy; the Colon-View examination for the early detection of intestinal bleeding that indicates a risk of colorectal cancer ( diagnostics); and POC test diagnosing celiac disease from fingerbrick blood sample. Biohit s Acetium capsule is the only way to reduce carcinogenic acetaldehyde in an anacidic stomach. An anacidic stomach may be a consequence of a) atrophic gastritis (the loss of glands and function of the stomac mucosa) resulting from H. pylori infection or an autoimmune disease, or b) medication taken to reduce stomach acidity ( Acetaldehyde is classified as a Group I carcinogen, a group that also includes asbestos, formaldehyde and benzene. All available means should be used to reduce exposure to these carcinogens in food and the organs. Biohit is headquartered in Helsinki and the company has a subsidiary in the UK. Since 1999, Biohit s Series B share has been quoted on NASDAQ OMX Helsinki in the Small cap/healthcare group. It is traded under the code BIOBV ( com/investors). Read more at Company profile 3

4 Innovation in the diagnosis of atrophic gastritis from blood sample GastroPanel GastroPanel innovation have been developed as a result of decades of basic medical research to reliably diagnose H. pylori infection and atrophic gastritis. Until their development, gastroscopy and pathological biopsy examination were the only reliable methods for the diagnosis of these conditions. 4 GastroPanel

5 Stomach health test for dyspeptic patients and screening of asymtomatic patients GastroPanel is a straightforward stomach health test from blood sample and a reliable tool for finding out the status and function of stomach mucosa. GastroPanel test provides doctors with laboratory data to support their clinical decisionmaking and helps to prioritize patients requiring further gastric investigations. GastroPanel report has been developed to assist doctors in interpreting the test results. GastroPanel is used as a first-line investigation of patients suffering from dyspepsia. It is a particularly useful tool for general practitioners and occupational health doctors, as the results can be used to assess the need for further investigations. GastroPanel is a patient-friendly test that provides an overview of the condition of the gastric mucosa. The results may also serve to motivate the patient to attend further investigations, including a gastroscopy. GastroPanel is a simple blood test that can be used to assess the condition of the gastric mucosa and to confirm the diagnosis of hypochlorhydria. GastroPanel will not only identify an H. Pylori infection but will indicate whether the changes in the mucosa are due to atrophic gastritis. GastroPanel can be used to: Identify patients with healthy gastric mucosa Diagnose H. pylori Diagnose atrophic gastritis Identify patients with hypochlorhydria Identify patients requiring gastroscopy GastroPanel will highlight the following risks: Vitamin B12 and other micronutrient deficiencies Peptic and duodenal ulcers Gastric and esophageal cancer GastroPanel will provide recommendations on further investigations: Gastroscopy and biopsy Helicobacter eradication treatment Further investigation of malabsorption or anaemia GastroPanel biomarkers GastroPanel Ordering Information Cat. No. Product Qty GastroPanel (tests)* 1 package Pepsinogen I ELISA kit* 96 tests Pepsinogen II ELISA kit* 96 tests Gastrin-17 ELISA kit 96 tests Helicobacter pylori IgG ELISA kit 96 tests Gastrin-17 Stabilizer* 1 x 5.5ml Gastrin-17 Stabilizer* 5 x 5.5ml *In the United States and Japan for research use only. GastroPanel 5

6 GastroPanel Report Patient Data Name Firstname Lastname (#1) Date of birth Age 69 Eradicated Use of PPI Acidic symptoms Use of NSAIDs Yes (over 1 y) Don't know No No GastroPanel Report With GastroPanel examination concentrations of four biomarkers in a blood sample are determined. Biomarkers secreted by the cells in gastric mucosa are pepsinogen I (PGI), pepsinogen II (PGII) and gastrin-17b (G17b). Additionally, Helicobacter pylori antibodies are measured. An overall interpretation of all four biomarker results provides a more reliable and comprehensive understanding of the condition and functioning of the gastric mucosa than could be achieved using just one or two biomarkers. As such, it can be argued that GastroPanel is a four biomarker test panel, as the panel is more than the sum of its parts. We also recommend to view the GastroPanel flowchart (below), which provides examples of how to interpret the biomarker results. However, please note that the GastroPanel report provides a more accurate interpretation of the results. Assay Data Collected Analyzed reference range: Pepsinogen I (PGI) 12,8 µg/l * µg/l Pepsinogen II (PGII) 7,5 µg/l 3-15 µg/l PGI/PGII 1,7 * 3-20 Gastrin 17B 34,0 pmol/l * < 7 pmol/l H. pylori antibodies (HPAB) 15,0 EIU < 30 EIU Interpretation The results indicate atrophic gastritis (loss of gastric glandural cells) in the corpus due to a past Helicobacter pylori infection. Acid secretion in the stomach is decreased. Ask a doctor about the possibility of undergoing gastroscopy. GastroPanel Report Ordering Information Cat. No. Product Qty GastroSoft software* *In the United States and Japan for research use only. DYSPEPTIC PATIENT IN GASTROPANEL EXAMINATION H. pylori - PGI, PGII, PGI/PGII, G-17b normal Healthy stomach H. pylori + PGI, PGII, PGI/PGII, G-17b normal H. pylori gastritis H. pylori + H. pylori - H. pylori + PGI and/or PGI/PGII low G-17b usually elevated PGI and/or PGI/PGII normal G-17b low H. pylori + PGI and/or PGI/PGII low G-17b low No risk of a stomach disease Increased risk of gastric or duodenal ulcer Atrophic gastritis (corpus) Hypochlorhydric or achlorhydric stomach Atrophic gastritis (antrum) or Increased secretion of gastric acid Atrophic pangastritis Gastroscopy does not produce clinically significant additional information Other diseases, such as intestinal diseases, lactose intolerance, celiac disease, gall stones, must be excluded Eradicate H. pylori infection Consider gastroscopy Increased risk of gastric and esophageal cancer Malabsorption (B12, iron, calcium, magnesium, some medicines) Increased risk of gastric cancer (atrophic gastritis) Increased risk of gastric or duodenal ulcer (increased secretion of gastric acid) Eradicate H. pylori infection Consider gastroscopy Increased risk of gastric and esophageal cancer GastroPanel biomarkers ( Agréus, Kuipers, Kupcinskas, Malfertheiner, DiMario, Leja, Mahachai, Niv, van Oijen, Perez-Perez, Rugge, Ronkainen, Salaspuro, Sipponen, Sugano, Sung.: Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers Scand J Gastroenterol 2012;47: GastroPanel

7 GastroPanel Laboratory The GastroPanel biomarker examination has been developed as a primary and follow-up tool for the diagnosis and treatment of patients suffering from dyspepsia-like symptoms and H. pylori infection. It is also recommended for use in screening of asymptomatic people for H. pylori infection on autoimmune disease caused by atrophic gastritis and related risks, such as gastric cancer, peptic ulcer disease and deficiency of vitamin B-12, iron, zinc and calcium. The GastroPanel Laboratory Concept has been designed to help the development of decentralized point-of-care laboratory diagnostics and the practice of safe, ethical and costeffective evidence-based preventive medicine. A GastroPanel Laboratory includes everything that is required for the running of GastroPanel examinations: reagents, equipment and training. Biohit offers four different-sized GastroPanel Laboratory products that include microtiter plate readers, programs, pipettes, disposables and reagents for performing GastroPanel biomarkers (Pepsinogen I, Pepsinogen II, Gastrin-17 and Helicobacter pylori antibodies). These products also include training for the use and service of the equipment provided. In addition to GastroPanel examinations, GastroPanel Laboratory is also suited for the running of any other micoplatebased diagnostic tests. GastroPanel Laboratory products cater for the needs of private doctors, health centers, reference and service laboratories as well as research institutions and hospitals. GastroPanel Laboratory, Small GastroPanel Laboratory, Medium GastroPanel Laboratory, Large GastroPanel Laboratory, Extra Large Find more information at > Diagnostics > Product brochures > GastroPanel Laboratories The state-of-the-art, highly informative, safe and cost-effective GastroPanel examination for diagnosing dyspepsia and Helicobacter pylori infection and atrophic gastritis does not involve any of the serious medical and ethical problems described below: The 13 C 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, and usually irreversible. Undiagnosed atrophic gastritis of the corpus (anacidic stomach) may cause gastric and esophageal 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. The absorption of dipyridamole, some iron products and antifungals (fluconazole, itraconazole), thyroxine and atazanavir is impaired in an anacidic stomach. Particularly in senior citizens, the risk of severe intestinal infections (such as giardiasis, malaria, Clostridium difficile and E. coli EHEC) may increase significantly. 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 known risk for gastric cancer. In some cases, gastric cancer is directly caused by H. pylori-induced gastritis. Hereditary gastric cancer occurs in less than 1% of the population. Furthermore, none of the aforementioned three H. pylori tests provide any information on excessive gastric acid secretion, which in patients with gastro-esophageal reflux disease may cause complications from this disease. Such complications are often asymptomatic and include ulcerative esophagitis and Barrett s esophagus, which may lead to esophageal cancer if left untreated. If complications of 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 13 C urea breath test and stool antigen test may give up to 40% false negative results for H. pylori infection, meaning that this infection and the associated cancer risks etc. are not diagnosed if the patient has atrophic gastritis, MALT lymphoma or bleeding peptic ulcer disease or if the patient is currently receiving antibiotics or PPI treatment. GastroPanel 7

8 Innovation in ELISA-based diagnostics Other ELISA tests Celiac Disease Panel diagnosis and follow-up of celiac disease and dermatitis herpetiformis Cellular Fibronectin nonspecific cancer marker IBD Panel diagnosis and differentiation of Crohn s disease and ulcerative colitis Anti-Telomere IgG ELISA diagnosis of Systemic Lupus Erythematosus (SLE) 8 ELISA tests

9 Celiac Disease Panel The Celiac Disease Panel is intended for the diagnosis and treatment follow-up of celiac disease and dermatitis herpetiformis. The test panel consists of ELISA kits for serum Anti- Gliadin IgA and IgG, Anti-Transglutaminase IgA and IgG, and immunofluorescence assay (IFA) kit for serum Anti-Endomysial IgA. The same, simple protocol is used in all the ELISA tests of the Celiac Disease Panel. Clinical background Autoimmune diseases are increasing in our society. It has, for example, recently been confirmed that celiac disease is much more common than generally thought. The overall lifetime incidence of celiac disease has been estimated to be 1:100 1:300. Celiac disease is characterized by the presence of villous atrophy in a jejunal biopsy specimen, and it is caused by hypersensitivity to gluten. Withdrawal of gluten from the diet cures the symptoms of patients and allows the villi to reappear. Untreated celiac disease can cause osteoporosis, anemia, infertility and neurological disorders. Patients with untreated celiac disease have a 10 times higher risk for malignant intestinal lymphoma. During the last few years it has become evident that the detection of gliadin and transglutaminase antibodies together with endomysial IgA antibodies provides a strong tool for identification of patients with celiac disease, as well as those with dermatitis herpetiformis. The tests are also suitable for follow-up of treatment by measurement of the reduction of the antibodies from the patient s serum. Measurement of both IgA as well as IgG antibodies is important as IgA deficient individuals (1:400) have 10 times higher incidence of celiac disease. Celiac Disease Panel Highly specific and sensitive Easy to perform and use at the same time Standardized reagents and short incubation times Celiac Disease Panel ordering information Cat. No. Product Qty Anti-Gliadin IgA ELISA Kit 96 tests Anti-Gliadin IgG ELISA Kit 96 tests Anti-Transglutaminase IgA ELISA kit 96 tests Anti-Transglutaminase IgG ELISA kit 96 tests Anti-Endomysial IgA (huc) IFA kit 48 tests In the United States and Japan for research use only. See also our rapid and easy Celiac quick test, page 15! ELISA tests 9

10 Inflammatory Bowel Disease (IBD) Panel The Inflammatory Bowel Disease (IBD) Panel is intended for the detection and differentiation of Crohn s disease and ulcerative colitis. The test panel consists of ELISA kits for Anti-Saccharomyces IgA and IgG (ASCA) and immunofluorescence assay (IFA) kit for antineutrophil cytoplasmic antibodies (ANCA). Biohit ASCA IgA and IgG ELISA kits detect qualitatively or Semi-quantitatively IgA and IgG class Anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. The tests are intended to aid in the diagnosis of patients with Crohn s disease. When using both IgA and IgG ASCA ELISA tests together, there is a marked increase in sensitivity. Biohit ANCA immunofluorescence assay (IFA) kit is intended for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol and formalin fixed human neutrophils as substrates. Atypical p-anca, which is anti-myeloperoxidase (MPO) negative, is a serological marker for ulcerative colitis. When used in combination with the Biohit ASCA IgA and IgG kits, atypical p-anca is a useful aid in the differential diagnosis between ulcerative colitis and Crohn s disease. Clinical background Over a million individuals in the United States and Europe suffer from non-specific inflammatory bowel disease, a chronic relapsing, inflammatory intestinal condition. IBD patients may have a variety of symptoms including diarrhea, abdominal pain and rectal bleeding. Weight loss is common. The two major forms of IBD are Crohn s disease and ulcerative colitis. In Western Europe the incidence of Crohn s disease is 5-7/ and the incidence of ulcerative colitis 6-12/ Patients with ulcerative colitis and Crohn s disease are at a higher risk of colorectal cancer. Since specific symptoms are lacking the differential diagnosis is difficult, requiring time consuming and expensive invasive techniques. However, serological markers offer a substantial aid in the diagnosis of IBD. Antineutrophil cytoplasmic antibodies (atypical p-anca) have been found in patients with ulcerative colitis (in 70%) while both IgA and IgG antibodies against the cell wall mannan of Saccharomyces cerevisiae (ASCA) are associated with Crohn s disease (in 50-80%). GastroPanel and GastroView examinations: Inflammatory Bowel Disease Panel Highly specific and sensitive Easy to use and automate Short incubation times Differentiates ulcerative colitis and Crohn s disease Cellular Fibronectin Test Fibronectins (Fns) are large glycoproteins present in both insoluble form in extra cellular matrix (ECM) and soluble form in various body fluids. The insoluble form is called cellular fibronectin (cfn) and the soluble form plasma fibronectin (pfn). Cellular Fibronectin (cfn) in citrate plasma is a marker for Tumors (non-specific) Risk of vascular complications, especially in diabetes Risk of stroke recurrence Safety of thrombolytic therapy in stroke. Elevated levels of cfn in plasma have been shown to be associated with increased risk of hemorrhagic transformation after treatment with tissue plasminogen activator (t-pa) Cellular Fibronectin (cfn) in cervicovaginal fluid is a marker for Risk of premature birth Cellular Fibronectin Test Marker for reactive conditions High sensitivity of detection Easy to use and automate Reported helpful as stroke follow-up treatment GastroPanel and GastroView examinations: 10 ELISA tests

11 Systemic Lupus Erythematosus (SLE) Test Anti-Telomere IgG ELISA for the diagnosis of systemic lupus erythematosus Systemic lupus erythematosus (SLE) is a typical autoimmune disease, which affects almost every organ of the body and which, with its various symptoms, resembles rheumatic diseases. Although SLE mainly affects women, men and even children can also be affected. Common disorders related to SLE are malar rash, discoid rash, sensitivity to sunlight, oral ulcers, arthritis, serositis, kidney problems (e.g. proteinuria), problems related with the central nervous system, blood circulation, the immune system, as well as antinuclear antibodies. The presence of multiple antibodies, especially IgG class antibodies directed against native double-stranded DNA (anti dsdna), is one of the most specific tests for SLE. Since the level of circulating antibodies to double-stranded DNA has important diagnostic and therapeutic implications in the treatment of patients with SLE, many techniques have been developed to measure these antibodies. Telomeres, which represent 0.15 % of the human genome, are highly repetitive sequences of the DNA (TTAGGG/CC- CTAA)n at the end of eukaryotic chromosomes. Human antibodies against telomeric DNA is more specific and sensitive test for SLE. The Anti Telomere IgG antibody test of Biohit measures by a sensitive and specific enzyme immunoassay procedure (ELI- SA) anti-telomere antibodies in the serum of an SLE patient. Unlike in the conventional DNA antibody tests, which use purified calf thymus DNA as capture antigens for autoantibodies, the newly developed Biohit anti telomere antibody assay is based on the use of double-stranded telomeric DNA as the capture antigen for the binding of antibodies. Biohit anti telomere antibody assay has several advantages over the conventional anti-dsdna tests in SLE screening. Anti-Telomere IgG Test High affinity to Anti Telomere IgG Increased specificity (human DNA sequence as a capture antigen) Reduced background, no cross-reactions High reproducibility Easily automated Cellular Fibronectin Test ordering information Cat. No. Product Qty Cellular Fibronectin ELISA kit* 96 tests *For research use only. Not for use in diagnostic procedures. Inflammatory Bowel Disease Panel ordering information Cat. No. Product Qty Anti-Saccharomyces IgG 96 tests (ASCA) ELISA kit Anti-Saccharomyces IgA 96 tests GastroPanel (ASCA) and ELISA GastroView kit examinations: p-anca IgG IFA kit 48 tests In the United States and Japan for research use only. Systemic Lupus Erythematosus Test ordering information Cat. No. Product Qty Anti-Telomere IgG ELISA kit 96 tests In the United States and Japan for research use only. ELISA tests 11

12 Innovation in rapid diagnostics Quick tests Lactose Intolerance and Helicobacter pylori biopsy Quick Tests have been developed in response to the need for accurate and quick biopsy diagnosis. ColonView Hb and Hb/Hp fecal occult blood tests are sensitive tools to aid diagnosis of colorectal cancer. The new Celiac quick test is rapid and easy point-of-care test for celiac disease. 12 Quick tests

13 Lactose Intolerance quick test Easy testing of lactose intolerance from duodenal biopsy specimens Biohit lactose intolerance quick test results are ready in 20 minutes. All you need is the test plate, reagent bottles and a timer. The test procedure simply involves dosing a few drops of reagents onto the biopsy specimen and a short incubation period. The results are read according to the indicator color on the test plate. Have confidence in your results. Fast results are also reliable. This is due to the principle of the Biohit quick test, which is based on a functional lactase enzyme unlike many other testing methods. The Biohit quick test not only indicates the presence of lactase enzyme in the biopsy sample, but also ensures the functioning of the enzyme. Lactose Intolerance quick test Rapid results during gastroscopy Accuracy and dependability Quick answers in challenging situations RESULTS IN 20 min FROM BIOPSY Lactose Intorelance Quick Test Cat. No. Product Qty Lactose Intorelance Quick Test 25 tests Lactose Intorelance Quick Test 10 tests In the United States and Japan for research use only min o C min o C 3 POSITIVE MILD POSITIVE NEGATIVE Quick tests 13

14 Helicobacter pylori quick test Test and report at the same time The Biohit H. pylori quick test results can be read in a few minutes enabling diagnosis and reporting at the site of gastroscopy. A biopsy specimen taken during gastroscopy can be tested immediately for H. pylori, or to determine the success of eradication therapy. The final confirmation of a negative test result is ready in just 30 minutes. RESULTS IN 2 min - 30 min FROM BIOPSY Could biopsy testing be easier? Using the Biohit H. pylori quick test is an easy one-step procedure. The biopsy specimen is immersed into the gel medium. If H. pylori urease is present in the specimen a red colour develops in the gel. Interpretation of the indicator colour is simple and does not require any specialist training. Helicobacter pylori quick test Rapid results during gastroscopy Effortless and easy testing Accuracy and dependability Helicobacter pylori Quick test Cat. No. Product Qty Helicobacter pylori Quick Test Kit In the United States and Japan for research use only. 50 tests 14 Quick tests

15 ColonView Hb and Hb/Hp tests Test for detection of Fecal Occult Blood (FOB) ColonView lateral flow tests are intended for simple detection of fecal occult blood (FOB) in stool samples. The detection of blood is based on sensitive and specific immunochemical detection of human hemoglobin or hemoglobin/haptoglobin complex. The principal application of Biohit ColonView Hb and Hb/Hp tests is to screen for lower gastrointestinal (GI) pathologies, such as colorectal cancers and large adenomas that bleed. RESULTS IN 5 min - 15 min ColonView Lateral Flow Tests Excellent screening tools for colorectal cancer and large adenomas that bleed User-friendly Sample Collection kits No dietary restrictions Quick and simple single-step tests 2-in-1 test cassette 5-15 min Fecal occult blood test C C - C C Cat. No. Product Qty ColonView Hb and Hb/Hp 30 tests T T T T In the United States and Japan for research use only. Celiac quick test For early intervention With Biohit celiac quick test it is easy to test for celiac disease right at the point of care. Results are obtained by testing antitissue transglutaminase (ttg) antibodies from blood sample. The blood sample is taken from finger tip and incubated with buffer on the test plate. Already after 10 minutes the result is ready for visual reading. The test is useful for general practitioners, endoscopists, outpatient departments and dietetics. RESULTS IN 10 min Celiac quick test Quick and easy finger-prick sample collection Quick results: diagnosis and reporting at one visit High accuracy and quality results Celiac quick test Cat. No. Product Qty Celiac quick test 20 test/package In the United States and Japan for research use only. Quick tests 15

16 Specific research reagents Monoclonal Antibodies Monoclonal antibodies (MAbs) are efficient tools for research in the area of cellular pathology, neurobiology and oncology as well as in research on human gastric biomarkers. All Biohit MAbs are of mouse origin and have been purified following in vitro production. They are all highly specific to their antigens and are applicable in immunohistochemistry, immunoprecipitation and/or Western blotting. 16 Monoclonal Antibodies

17 Monoclonal Antibodies Specificity Clone # Host Subclass Format Qty Applications* Paraffin** Ordering # Monoclonal Antibodies to Human Gastric Biomarkers Pepsinogen I 4C6.1 mouse IgG 1 purified 100 μg IHC yes Pepsinogen II L10CC10 mouse IgG 1 purified 100 μg IHC yes Gastrin-17 G52C7.1 mouse IgG 1 purified 100 μg IHC yes Monoclonal Antibodies to Phytoestrogen Genistein L22FA2 mouse IgG 1 purified 100 μg EIA, FIA Monoclonal Antibodies to Human Extracellular Matrix Components Cellular Fibronectin (cfn) DH1 mouse IgG 1 purified 100 μg IHC, WB, EIA no Tenascin-C EB2 mouse IgG 1 purified 100 μg IHC, WB, EIA no Tenascin-C DB7 mouse IgG 2a purified 100 μg IHC, WB yes Laminin (ß 1 -chain) DG10 mouse IgG 1 purified 100 μg IHC, WB no Laminin (ɣ 1 -chain) BC7 mouse IgG 1 purified 100 μg IHC, IP no Plasma Fibronectin (pfn) BF12 mouse IgG 1 purified 100 μg IHC, WB no Vitronectin BE10 mouse IgG 1 purified 100 μg IHC, WB no Monoclonal Antibodies to Human Integrins ß 1 -Integrin DF5 mouse IgG 1 purified 100 μg IHC, WB yes ß 1 -Integrin DF7 mouse IgG 1 purified 100 μg IHC, WB yes ß 3 -Integrin BB10 mouse IgG 1 purified 100 μg IHC, WB no IIb -Integrin CA3 mouse IgG 1 purified 100 μg IHC, WB no Monoclonal Antibodies to Human Endothelial Cell Surface Marker PECAM-1 CE6 mouse IgG 1 purified 100 μg IHC, WB no Monoclonal Antibodies to Human Neurotransmitter Substances GABA 5A9 mouse IgG 1 purified 100 μg IHC, EIA yes CGRP CD8 mouse IgG 1 purified 100 μg IHC, WB, EIA yes Monoclonal Antibodies to Human Cytoskeletal Polypeptides -Actinin CB11 mouse IgG 1 purified 100 μg IHC, WB no Fodrin AA6 mouse IgG 1 purified 100 μg IHC, WB no Vinculin FB11 mouse IgG 1 purified 100 μg IHC, WB no Cytokeratin 18 4B11 mouse IgG 1 purified 100 μg IHC, WB, IP no Cytokeratin 8,18,19 2A4 mouse IgG 1 purified 100 μg IHC, WB no Cytokeratin 7,17,19 4F5 mouse IgG 1 purified 100 μg IHC, WB no Vimentin 65E mouse IgG 1 purified 100 μg IHC, WB no Neurofilaments 150, AA mouse IgG 1 purified 100 μg IHC, WB no Neurofilaments 70, BA mouse IgG 1 purified 100 μg IHC, WB no Monoclonal Antibodies to Human Spectrins Erythroid α -Spectrin AF10 mouse IgG 1 purified 100 μg IP, WB, IHC no Erythroid βß-spectrin DB2 mouse IgG 1 purified 100 μg IP, WB, IHC no MAbs in other concentrations and in different buffer systems are available at request. *The Biohit monoclonal antibodies are applicable in: IHC = Immunohistochemistry, WB = Western Blotting, FIA = Time-resolved Fluorescence Immunoassay, IP = Immunoprecipitation EIA = Enzyme Immunoassay ** Reactivity with paraffin sections Monoclonal Antibodies 17

18 Eliminates carcinogenic acetaldehyde from anacidic stomach Acetaldehyde binding products Acetaldehyde is a Primary Carcinogen often found in the stomach. It s particularly harmful if you use anti-acid medication, have anacidic stomach or chronic H. pylori infection 18 Acetaldehyde binding products

19 Acetium -capsule Many of the foods and drinks we consume every day contain small amounts of alcohol. The microbes in the digestive tract can efficiently turn this alcohol into high amounts of acetaldehyde, which is the most significant by-product of alcohol metabolism. Many foods and drinks, particularly those produced by fermentation, have a high acetaldehyde content. In addition, the microbes in the digestive tract can produce high amounts of acetaldehyde from sugars. The cancer risk posed by acetaldehyde is increased by the fact that we are ingesting acetaldehyde all the time from many different sources. Globally, acetaldehyde exposure is linked to approximately four million new cases of cancer each year that represents nearly 40 per cent of all cancers. Acetium Acetaldehyde exposure is linked to approximately 4 million new cases of cancer annually This represents nearly 40 % of all cancers Acetaldehyde is especially dangerous for acid-free stomachs and those who regurarly take anti-acid medication or suffer from chronic Helicobacter pylori infection Acetium capsules protect your stomach from carcinogenic acetaldehyde locally in the stomach Acetaldehyde is as class I carcinogen harmful for everyone. As a result of microbial activity, it accumulates in our mouth and intestinal tract. Normally, however, the gastric acid in our stomach kills the oral bacteria and yeasts we swallow, thus preventing acetaldehyde formation in the stomach. This is why people suffering from low stomach acid are particularly at risk. Low stomach acid, also known as achlorhydria, can be caused by atrophic gastritis or the use of anti-acid medication. People with Helicobacter pylori infection are also in the high-risk group Asetaldehyde in stomach Acetium reduce the level of carcinogenic acetaldehyde locally in the stomach. Acetium capsules contain 100 mg of L- cysteine as their active ingredient. Acetium capsules release L-cysteine locally in the stomach at a sustained rate. The L- cysteine efficiently binds the acetaldehyde formed as a result of microbial activity in the gastric juices Time in minutes Amount of asetaldehyde (µm) in anacidid stomach when added L-cysteine Amount of asetaldehyde (µm) in anacidid stomach Reference: Väkeväinen et al., ScandJGastroenterol 2002 Linderborg et al. 2009, of Abstracts (adapted) Acetium Cat. No. Product Qty Acetium FI-SWE-EN 4 x 15 blisters Acetium GER 4 x 15 blisters Acetium FRA 4 x 15 blisters Not available in the United States Acetaldehyde binding products 19

20 Instruments BP 800 Microplate Reader The BP 800 Microplate Reader has all the features of a modern microplate photometer to automatically perform endpoint analysis for a variety of ELISA-based applications. With the help of the in-build intuitive user interface, new test protocols can be made fast and easily. Extensive on-board data reduction surpasses many personal computer software packages with its extensive curve-fitting, cut-off calculation, data transformation and validation capabilities. The BP800 is designed to serve as a stand-alone system, or as part of a larger laboratory data network, sending receiving, and manipulating assay data as needed. Therefore, in addition to the printer interface, the instrument has a serial interface to be controlled with a personal computer for further processing and distribution of data. BP 808 Microplate Reader The BP 808 Microplate Reader is an 8-channel microplate photometer (IU-model) with four-zone incubation to 50 C and a linear shaking. Due to the fast reading capability the unit is also suitable for kinetic applications. In-build user interface, data reduction, serial and parallel I/O are provide as with the BP800, offering an advanced reader for different kind of application. e-lisa XL Reader Software The e-lisa XL is the most easy-to-use, yet useful software utility for supporting the Biohit microplate readers with end point type assays such as the Biohit GastroPanel assays - Pepsinogen I and II, Gastrin-17 and Helicobacter pylori or other Biohit ELISA based tests. It has been designed to be used together with Microsoft Excel, providing numerous possibilities for data processing and validation. The e-lisa XL is delivered with Excel templates for Biohit assays. The Biohit BP-series microplate readers are delivered with the Biohit e-lisa XL for Windows, providing immediate easy-to-use measurements when PC is used to control the reader. Instruments Cat. No. Product BW 50 Washer The BW 50 is a self-contained and programmable microplate washer suitable for EIA, FIA, RIA, DNA probe and cellular assays. It allows full control of precise fluidic delivery from the gentle dripping of a simple squeeze bottle to the full force of pressure delivery systems. The BW50 is a perfect companion for the Biohit s BP-series readers. The built in user interface and the on-board software enable similar intuitive easy programming as with the BP-readers. This commonality allows the laboratory technician to easily develop both washing and data reduction protocols for those assays of interest. The BW50 can be delivered preprogrammed for Biohit diagnostic kits BP800 Microplate Photometer BP800 Micoplate Photometer 340 nm (UV) BP800 Microplate Photometer 384 (NB) BP808 Microplate Photometer BP808 Microplate Photometer (UV, I) BW50/8 Microplate Strip Washer BW50/16 Microplate Strip Washer BP50/12 Microplate Strip Washer BP50/8V Microplate Strip Washer 20 Instruments

21 Service Laboratory Service Laboratory Biohit Service laboratory promotes the evaluation and adoption of Biohit s diagnostic tests and analysing systems. Biohit service laboratory engages in the research and development of diagnostic tests and the analysis of different types of patient data in co-operation with scientific communities in Finland and abroad. The purpose of the Biohit Service laboratory is to collect patient samples, e.g., from health care and occupational health service centers, other medical centers as well as regional and central hospitals. Furthermore, the purpose is to encourage the users of the laboratory service to begin making the necessary analyses themselves with the help of the analysing systems purchased from Biohit. This enables the customer to receive the test results more easily, rapidly and at a lower cost. The performance of the analyses as close as possible to the patient and doctor promotes decentralized laboratory diagnostics, which is usually the most optimal, and, thus, the most recommended way. Decentralized laboratory diagnostics which promotes evidence-based medicine should be striven for not only for the benefit of the patient and the doctor but also since it decreases the costs of health care. Performed by Biohit service laboratory: GastroPanel examination - Helicobacter pylori IgG - Pepsinogen I - Pepsinogen II - Gastrin-17 GastroPanel select - Helicobacter pylori IgG - Pepsinogen I - Pepsinogen II Celiac Disease Panel Celiac Quick Test from blood sample ColonView Hb and Hb/Hp FOB test Inflammatory Bowel Disease Panel Cellular fibronectin Anti-Telomere IgG for SLE Lactose Intorelance Quick test from biopsy specimen H. pylori Quick test from biopsy specimen Determination of acetaldehyde Determination of acetaldehyde concentration in foodstuff Biohit service laboratory offers analyses of carcinogenic acetaldehyde in foodstuff and non-alcoholic and alcoholic beverages. If you wish to send an example to be analyzed in Biohit laboratory please contact: info@biohit.com. Acetaldehyde in foods some fruits, such as apples, pears and berries, and can also be used as a fruit preservative. Since exposure to acetaldehyde is cumulative, exposure should be avoided at all levels. The easiest way to do this is to intervene in the acetaldehyde contained in alcoholic beverages and foods. The market already contains alcoholic beverages and other foodstuffs with an acetaldehyde concentration below the safety limit or close to zero. Acetaldehyde is a commonly used substance with an apple fragrance and amply present in nature. Hundreds of tons of the chemical are manufactured annually for use by industry. In particular, acetaldehyde is abundantly present in foods whose manufacture includes a fermentation process, such as alcoholic beverages, vinegar, dairy products, home brewed beer and mead. Thanks to its pleasant smell, acetaldehyde is used as flavoring in yogurts, sweets, deserts, pastries, soft drinks, fruit juices and alcoholic beverages. In addition, acetaldehyde can be formed endogenously in reveals acetaldehyde exposure Service Laboratory 21

22 Collaboration opportunities Biohit is constantly looking for new partnering (outlisencing partners, distributorships) opportunities for the following products. Please contact us by for further information. Acetium Acetium capsule reduces the amount of carcinogenic acetaldehyde in stomach. Acetaldehyde is particularly harmful for those people who have achlorhydric stomach or who regularly use PPI medication. Acetium is a new groundbreaking innovation, the only one of its kind in the world. Learn more at GastroPanel GastroPanel examination comprises ELISA assays for H. pylori, IgG, Pepsinogen I, Pepsinogen II and Gastrin-17. GastroPanel is a patient-friendly blood test for assessing the condition of the stomach. Learn more at GastroPanel Laboratories Comprehensive GastroPanel Laboratories include microplate analyzing systems, programs, pipettes, disposables and reagents for performing the GastroPanel tests. In addition to the GastroPanel tests, these turn-key laboratories are also suited for running any other microplate-based immunoassays. GastroPanel Laboratories are ment for private doctors, health centers, reference and service laboratories as well as research institutions and hospitals. Lear more at com/diagnostics/product-brochures (GastroPanel Laboratories pdf). Lactose Intolerance Quick Test Lactose Intolerance Quick Test at gastroscopy enables a fast diagnosis of the patients suffering from lactose intolerance. The test is easy-to-use, highly sensitive and specific. Learn more at products/18/lactose-intolerance-quick-test. Helicobacter pylori Quick Test H. pylori Quick Test offers a simple and highly specific method for detecting H. pylori in connection with gastroscopy. Learn more at References GastroPanel Agréus L, Kuipers EJ, Kupcinskas L, Malfertheiner P, Di Mario F, Leja M, Mahachai V, Yaron N, van Oijen M, Perez Perez G, Rugge M, Ronkainen J, Salaspuro M, Sipponen P, Sugano K, Sung J. Rationale in diagnosis and screening of atrophic gastritis with stomach specific plasma biomarkers. Scand J Gastroenterol 2012; 47: Germana B, Di Mario F, Cavallaro LG, Moussa AM, Lecis P, Liatoupolou S, Comparato G, Carloni C, Bertiato G, Battiestel B, Papa N, Aragona G, Cavestro GM, Iori V, Merli R, Bertolini S, Caruana P, Franz e A. Clinical usefulness of serum pepsinogens I and II, gastrin-17 and anti-helicobacter pylori antibodies in the management of dyspeptic patients in primary care. Digestive and Liver Disease 2005; 37: Sipponen P, Härkönen M. Hypochlorhydric stomach: a risk condition for calcium malabsorption and osteoporosis? Scand J Gastroenterol 2010; 45: Storskrubb T, Aro P, Ronkainen J, Sipponen P, Nyhlin H, Talley NJ, Engstrand L, Stolte M, Vieth M, Walker M, Agreus L. Serum biomarkers provide an accurate method for diagnosis of atrophic gastritis in a general population: The Kalixanda study. Scand J Gastroenterol 2008; 43: Telaranta-Keerie A, Kara R, Paloheimo L, Härkönen M, Sipponen P. Prevalence of undiagnosed advanced atrophic corpus gastritis in Finland: an observational study among 4256 volunteers without specific complaints. Scand J Gastroenterol 2010; 45: Väänänen H, Vauhkonen M, Helske T, Kääriäinen I, Rasmussen M, Tunturi-Hihnala H, Koskenpato J, Sotka M, Turunen M, Sandström R, Ristikankare M, Jussila A, Sipponen P. Non-Endoscopic Diagnosis of Atrophic Gastritis with a Blood Test. Correlation between Gastric Histology and Serum Levels of Gastrin-17 and Pepsinogen I. A Multicentre Study. Eur J Gastroenterol Hepatol 2003; 15: Celiac Disease panel Collin P, Hällstrom O, Mäki M and Viander M. A typical celiac disease found with serologic screening. 1990: Scand J Gastroenterol 25: Mäki M, Läheaho ML, Hällstrom O et al. Postpubertal gluten challenge in celiac disease Arch Dis Child 64: Troncone R, Maurano F, Rossi M et al. IgA Antibodies to tissue transglutaminase: An e ective diagnostic test for celiac disease. 1999: J Pediatr 134: Walker-Smith JA, Guandalini S, Schmitz J et al. Revised criteria for diagnosis of celiac disease. Archives of Disease in Childhood 1990; 65: Rubio-Tapia A, Ludvigsson JF, Brantner TL, Murray JA, Everhart JE. The Prevalence of Celiac Disease in the United States. Am J Gastroenterol Jul 31. doi: /ajg Collaboration opportunities

23 Cellular Fibronectin Test Castellanos M, Sobrino T, Millan M et al. Serum Cellular Fibronectin and Matrix Metalloproteinase-9 as Screening Biomarkers for the Prediction of Parenchymal Hematoma After Thrombolytic Therapy in Acute Ischemic Stroke. A Multicenter Conrmatory Study. Stroke 2007 May 3. Castellanos M, Leira R, Serena J et al. Plasma cellular-fibronectin concentration predicts hemorrhagic transformation after thrombolytic therapy in acute ischemic stroke. Stroke 2004; 35: Haglund C, Ylätupa S, Mertaniemi P, Partanen P. Cellular fibronectin concentration in the plasma of patients with malignant and benign diseases. A comparison with CA 19-9 and CEA. Br J Cancer 1997; 76: Koskiniemi M, Rajantie J, Rautonen J et al. Fibronectin concentration in cerebrospinal!uid re!ects early central nervous system involvement in children with acute lymphoblastic leukemia. Leuk Res 1990; 14: Ylätupa S, Haglund C, Mertaniemi P, Vahtera E, Partanen P. Cellular bronectin in serum and plasma. A potential new tumor marker? Br J Cancer 1995; 71: Systemic Lupus Erythematosus (SLE) Test Julkunen H, Salonen EM, Walle TK, Miettinen A. Anti-nucleosome antibodies in the diagnosis of systemic lupus erythematosus. Scand J Rheum 2005; 34: Salonen EM, Miettinen A et al. Anti-telomere antibodies in systemic lupus erythematosus (SLE): a comparison with ve antinuclear antibody assays in 430 patients with SLE and other rheumatic diseases. Ann Rheum Disease 2004 Oct;63(10): Salonen EM, Ruuskanen L, Friman C. Anti-telomere antibodies in SLE. Arthr & Rheum, 1996; 39:40. Svenungsson E; Jensen-Urstad K, Heimburger M et al. Risk Factors for Cardiovascular Disease in Systemic Lupus Erythematosus. 2000; 104: Wallace DJ, Salonen EM et al. Anti-telomere antibodies in systemic lupus erythematosus: a new ELISA test for anti-dna with potential pathogenetic implications.lupus 2000; 9: Inflammatory Bowel Disease (IBD) Panel Bartunkova J, Kolarova I, Sediva A, Holzelova E. Antineutrophil cytoplasmic antibodies, anti-saccharomyces cerevisiae antibodies, and specic IgE to food allergens in children with inflammatory bowel diseases. Clin Immunol 2002; 102: Conrad K, Schmechta H, Klafki A, Lobeck G, Uhlig HH, Gerdi S, Henker J: Serological differentiation of in!ammatory bowel diseases. Eur J Gastroenterol Hepatol 2002; 14: Damoiseaux JGMC, Bouten B, Linders AMLW et al. Diagnostic value of anti-saccharomyces cerevisiae and antineutrophil cytoplasmic antibodies for in!ammatory bowel disease: high prevalence in patients with celiac disease. J Clin Immunology 2002; 22: Furuya D, Yagihashi A, Komatsu M et al. Serum interleukin-18 concentrations in patients with inflammatory bowel disease. J Immunother 2002; 25 Suppl 1:S65-7. Hanauer SB, Sandborn W, and The Practice Parameters Committee of the American College of Gastroenterology: Management of Crohn s disease in adults. Am J Gastroenterol 2001; 96: Lactose Intolerance Franzè J, Parodi A, Savarino E, Morana E, Bertelè A, Savarino V, Di Mario F. A comparison between lactose breath test and quick test on duodenal biopsies for lactase deficiency, in patients with self reported lactose intolerance. Gut 2009; 58(Suppl II):A261. Ghanghro I, Basu S, Vidyarthi M, McTaggert C, Hollanders D. The Incidence of Lactose Deficiency in an endoscopically and histologically normal group of white Caucasians. Gastroenterology Today 2009; 19(3): Kuokkanen M, Myllyniemi M, Vauhkonen M, Helske T, Kääriäinen I, Karesvuori S, Linnala A, Härkönen M, Järvelä I, Sipponen P. A biopsy-based quick test in the diagnosis of duodenal hypolactasia in upper gastrointestinal endoscopy. Endoscopy 2006; 38(7): Ojetti V, La Mura R, Zocco MA, Cesaro P, De Masi E, La Mazza A, Cammarota G, Gasbarrini G, Gasbarrini A. Quick test: a new test for the diagnosis of duodenal hypolactasia. Dig Dis Sci Jun;53(6): Orlandi M, Netzer P, Inauen W. IDENTIFYING LACTOSE INTOLERANCE WITH A NOVEL BIOPSY-BASED RAPID LACTASE TEST. Gut 2006; Vol 55 (suppl V): A98 Fecal Occult blood tests Luthgens K et al. Hemoglobin-Haptoglobin Complex: A Highly Sensitive Assay for the Detection of Fecal Occult Blood. Clinical Laboratory 1998; 44: Miller AB. An Epidemiological Perspective on Cancer Screening. Clinical Biochemistry1995; 28(1): Ransohoff DF and Lang CA. Improving the Fecal Occult- Blood Test. The New England Journal of Medicine 1996; 334 (3): Screening for Colorectal Cancer-United States ; and New Guidelines; Mobility and Mortality Weekly Report 1995; 45 (5): Sieg A et al. Detection of colorectal neoplasms by the highly sensitive hemoglobin-haptoglobin complex in feces. International Journal of Colorectal Disease 1999; 14: Yamamoto M.; Nakama H.; Cost-e ectiveness analysis of immunochemical occult blood screening for colorectal cancer among three fecal sampling methods: Hepatogastroenterology; 2000 Mar-Apr; 47(32): Monoclonal Antibodies Auranen M et al. Muscle membrane-skeleton protein changes and histopathological characterization of muscle-eye-brain disease. Neuromusc Disord 2000: 10: Jongen-Relo AL et al. Distribution of GABAergic cells and fibers in the hippocampal formation of the macaque monkey: an immunohistochemical and in situ hybridization study. J Comp Neurol 1999: 408: Korhonen M et al. Unaltered distribution of laminins, fibronectin, and tenascin in celiac intestinal mucosa. J Histochem Cytochem 2000: 48: Li TF et al. Expression of vitronectin and its integrin receptors in the synovial membrane-like interface tissue from aseptic loosening of total hip replacement. J Rheumatol 2000: 27: Sormunen R et al. Immunolocalization of the fodrin, E-cadherin, and beta-catenin adhesion complex in infltrating ductal carcinoma of the breast-comparison with an in vitro model. J Pathol 1999: 187: Ylätupa S et al. Cellular fibronectin in serum and plasma: a potential new tumour marker? Br J Cancer 1995: 71: Acetaldehyde binding products Linderborg K, Marvola T, Marvola M, Salaspuro M, Färkkilä M, Väkeväinen S. Reducing Carcinogenic Acetaldehyde Exposure in the Achlorhydric Stomach With Cysteine. Alcohol Clin Exp Res 2010; 35(3): Linderborg K, Salaspuro M, Väkeväinen S. A single sip of a strong alcoholic beverage causes exposure to carcinogenic concentrations of acetaldehyde in the oral cavity.food Chem Toxicol Sep;49(9): Salaspuro M. Interactions of alcohol and tobacco in gastrointestinal cancer. J Gastroenterol Hepatol 2012; 27 (Suppl 2): Salaspuro M. Acetaldehyde as a common denominator and cumulative carcinogen in digestive tract cancers. Scand J Gastroenterol Salaspuro V, Salaspuro M. Synergistic effect of alcohol drinking and smoking on in vivo acetaldehyde concentration in saliva. Int J Cancer 2004;111: References 23

24 Contact details BIOHIT OYJ Laippatie Helsinki, Finland Tel: Fax: info@biohit.fi U.K. Biohit HealthCare Ltd. Pioneer House Pioneer Business Park North Road Ellesmere Port Cheshire CH65 1AD UNITED KINGDOM Tel: Fax: sales@biohithealthcare.co.uk CHINA Biohit HealthCare consulting (Shanghai) Co., Ltd Room 803, Office Block Hotel Equatorial 65 West YanAn Road Shanghai, P. R. China Tel: Fax: info.china@biohit.com Biohit Oyj GastroPanel