INTERIM REPORT OF BIOHIT GROUP 1 JANUARY TO 30 SEPTEMBER 2006
BIOHIT OYJ STOCK EXCHANGE RELEASE 3 NOVEMBER 2006 AT 10:00 AM
INTERIM REPORT OF BIOHIT GROUP 1 JANUARY TO 30 SEPTEMBER 2006
The Biohit Group had total net sales of EUR 22.7 million during
the reporting period (EUR 20.3 million in 1Q-3Q/2005). The
operating loss for the reporting period was EUR 0.0 million
(operating loss EUR 0.3 million). The loss for the reporting
period was EUR 0.7 million (loss EUR 0.5 million). The result was
weakened by increased fixed costs and finance costs.
Net sales
The Biohit Group net sales increased 12 % compared with the
corresponding period in 2005 and totalled EUR 22.7 million (EUR
20.3 million). Net sales growth, however, remained below the
targets set. Sales in the Asian market area and of diagnostics
products in particular have not yet developed as anticipated.
Of the Groups net sales 94 % were generated primarily from the
sale of liquid handling products and maintenance services for
liquid dispensers. The liquid handling business net sales were EUR
21.4 million (EUR 19.3 million), the net sales for the diagnostics
business being EUR 1.3 million (EUR 1.0 million).
Result
The operating loss was EUR 0.0 million (operating loss EUR 0.3
million). The loss for the reporting period was EUR 0.7 million
(loss EUR 0.5 million).
The operating profit of the liquid handling business was EUR 1.7
million (operating profit EUR 1.6 million), the operating loss of
the diagnostics business being EUR 1.7 million (operating loss EUR
1.9 million).
The sales development being weaker than expected affects the
result of the whole Group. The result is also burdened by
increased finance costs and fixed costs, which mainly stem from
outlays associated with operations in China and the restructuring
of the organisation in Japan.
Balance sheet
The balance sheet total was EUR 27.3 million (EUR 23.7 million)
and the equity ratio was 49.7 % (58.5 %) on 30 September 2006. The
balance sheet total was increased and the equity ratio decreased
by the issuance of a EUR 4.05 million convertible bond in November
2005. In accordance with a decision made at the Annual General
Meeting on 20 April 2006, the share premium fund has been used to
cover the parent company's EUR 0.6 million losses for 2005.
Additionally, EUR 12.2 million have been transferred from the
share premium fund to a non-appropriate equity fund.
Liquidity
During the reporting period, the operating activities had a net
cash flow of EUR 0.4 million (EUR 0.6 million). At the end of the
reporting period, the liquid assets of the Group totalled EUR 1.5
million (EUR 1.0 million).
Investments
Gross investments in the reporting period totalled EUR 1.4 million
(EUR 1.4 million). The costs mainly consist of equipment for the
automation of liquid handling product manufacture at the Kajaani
and Helsinki production facilities, as well as investments made in
the production facility in China.
Personnel
The average number of personnel in the reporting period was 302
(297), with 161 (164) persons being employed by the parent company
and 141 (133) by the subsidiaries.
Main events of the reporting period
Liquid handling business area
Biohits liquid handling business includes mechanical and
electronic liquid dispensers as well as disposable tips. In
addition, the company offers services related to the maintenance
and calibration of liquid handling products as well as training
services on these products. The companys liquid handling products
are combined with diagnostic products, instruments and related
software, forming comprehensive analysis systems for research and
clinical diagnostics.
The sales of pipettor and pipettor tips continue to increase. In
spite of heightened competition in the market, the greatest
increase has been seen in mechanical pipettors. The company has
been particularly successful as a supplier to companies in the
pharmaceutical and biotechnology industries.
The number of partners in co-operation with respect to robotic
pipettors, which are used in analysis instruments and systems, has
also risen during the review period. However, a characteristic of
this business is that notable growth in sales only occurs 1-2
years after the launch of co-operation projects. The ISO 13485
quality certificate granted to Biohit during the review period
also bolstered the companys position in the Original Equipment
Manufacture (OEM) market.
During the review period, Biohit continued the launch of its
maintenance concept in its subsidiaries and distribution network,
with an initial focus on Europe. The new global maintenance
concept, which aims at end-to-end management of the pipettor
lifecycle and increased customer satisfaction, has had a
favourable effect on the companys net sales and result. As part
of this maintenance concept, the company has completed a new type
of pipettor maintenance and calibration management software whose
distribution will begin in main market areas during the fourth
quarter.
Diagnostics business area
During the review period, Biohit has made several agreements on
the sale and marketing of GastroPanel and other diagnostics
products, e.g. in Spain, France, Greece, Iceland and Turkey.
GastroPanel was cleared for marketing and distribution in Ukraine
during the review period. In the United States, the FDA (Food and
Drug Administration) is still evaluating the Pepsinogen I and II
tests, and further tests required by the FDA are underway.
Chinese healthcare representatives held the 2006 Gastritis
Consensus Workshop in Shanghai on 15-16 September 2006. Pioneers
in the field Professor Pelayo Correa from the USA and Professor
Pentti Sipponen from Finland were the only foreigners invited to
the workshop, which had almost a hundred participants. At the
workshop, it was decided that GastroPanel tests would be
introduced into Chinas healthcare system.
New product - GastroView
Alongside the GastroPanel examination, Biohit has developed and
submitted a patent application for the easy-to-use and cost-
effective GastroView examination. The GastroView examination also
serves customers who have periodic or chronic upper abdominal
pains or complaints (dyspepsia). Over a million patients in
Finland will suffer from dyspepsia-like complaints at some point
in their lives. By using the GastroView examination, those
suffering from dyspepsia can obtain valuable preliminary data for
self-medication, or even before visiting a doctor. Many people who
feel well are also interested in obtaining information about their
health. This is well founded, because the atrophic gastritis
(functional disorder of the stomach due to atrophy of the mucous
membrane) caused by Helicobacter pylori infection (or rarely by an
autoimmune disease) usually occurs partially or completely without
symptoms.
Corpus atrophic gastritis may well eventually lead to gastric
cancer and vitamin B12 deficiency. As the population ages, the
number of such patients is increasing. Vitamin B12 deficiency can
lead to complaints such as dementia, depression and damage to the
peripheral nervous system (www.b12.com), and an increased level of
homocysteine in the system, which is itself believed to be an
independent risk factor for atherosclerosis, as well as heart
attacks and strokes (www.homocysteine.com / see, for example,
Geography).
GastroView is primarily intended for healthcare centres, general
practitioners and company doctors. Blood samples taken from
fingertips may be sent to Biohits service laboratory by places
such as chemists, health resorts, nursing homes and sheltered
accommodation for veterans and senior citizens, physiotherapists
(about 2,500 companies in Finland), trained chiropractors
searching for nerve damage, and nutrition specialists. The product
is not yet expected to generate notable net sales during the 2006
financial year.
More information about GastroView is available in the end of this
release.
GastroMate analyser
To supplement the current analysis system, Biohit is developing a
user-friendly automatic analyser for private clinics, health
centres, emergency rooms and special analyses. This analyser would
support decentralised laboratory diagnostics, and therefore
promote both more rapid diagnoses during doctors appointments and
the likelihood of receiving the correct treatment (evidence-based
medicine).
Tekes (the Finnish Funding Agency for Technology and Innovation)
has awarded a grant to the GastroMate analyser development
project, which was begun in 2004. GastroMate performs the
GastroView and GastroPanel tests on blood samples. GastroSoft
software then evaluates and creates a report on the test results,
as well as saving them for later use. By the end of November, a
prototype will have been completed and testing may start.
Private clinics are GastroMates largest customer group and it is
estimated that there are 100,000 such clinics in Japan, 70,000 in
Germany and 50,000 in Italy. As well as wanting to improve the
level of diagnosis and treatment they offer, such clinics housing
either one or several doctors also try to increase their
practices profits by performing their own laboratory diagnoses.
This constitutes another way of encouraging patient loyalty.
More information about the GastroMate project is available in the
end of this release.
The elimination of carcinogenic acetaldehyde from foodstuffs and
the gastrointestinal tract
During the review period, Biohit has completed a prototype for
XyliCyst chewing gum, and the company is currently seeking
manufacturers and distributors. XyliCyst eliminates the
acetaldehyde in the mouth that is formed from alcohol or dissolved
from tobacco into saliva.
There are around a billion smokers in the world, and around two
million people per year develop cancers of the upper
gastrointestinal tract that are primarily caused by smoking and
alcohol consumption. Licences are being offered to the food
industry for both XyliCyst and the BioFood method. The BioFood
method eliminates the carcinogenic acetaldehyde contained in many
food substances, such as yogurt and beer.
Biohit has also been focusing on the development of its BioCyst
nutritional supplements (such as capsules), which rid low-acid or
anacidic stomachs of the carcinogenic acetaldehyde produced by
oral bacteria from sugars, carbohydrates and alcohol. Corpus
atrophic gastritis and the resulting anacidic stomach can be
diagnosed using Biohits GastroPanel and GastroView examinations.
About 300 to 500 million people in the world are estimated to have
anacidic or low-acid stomachs in which oral bacteria can live and
produce carcinogenic acetaldehyde.
BioCyst products can be marketed by, for example, chemists (in the
UK there are over 10,000 chemists belonging to 1,000-1,500 chains)
as well as chains and companies that market and sell nutritional
supplements and similar products.
More information on carcinogenic acetaldehyde is available in the
end of this release.
Production to serve China and its surrounding markets
In September, Biohit opened a new production facility in Suzhou,
near Shanghai. As production has only just started up, no net
sales have yet been generated.
The facility, which focuses on pipettor assembly, and the
administrative and marketing centre in Shanghai, will primarily
serve the growing Asian markets. China has the second most rapidly
growing diagnostics market in the world, at an annual rate of 16
per cent.
Initially, the facility produces mechanical mLINE and Proline
pipettors. Pipettors sold in Finland, Europe and the USA will
still be produced at the companys Kajaani facility. Norwegian-
born Eirik Pettersen has been appointed Country Manager for China.
On 15-16 September, the Gastritis Consensus Workshop was held in
Shanghai, China. At this workshop, it was decided that GastroPanel
tests would be introduced into Chinas healthcare system. It is
possible that, as demand for GastroPanel and GastroView grows,
packaging of test kits assembled from key components manufactured
in Finland will begin in Suzhou.
A change in Biohit Oyjs shareholding
On 21 June 2006, Pentti Sipponen gave notification that he had
acquired 900,000 Biohit Oyj Series A shares from Erja-Yhtymä Oy.
After the flagging notification, the holding in Biohit Oyjs share
capital and voting rights of the shareholder (Pentti Sipponen),
and the holder of shares falling under his shareholding (Patolab
Oy), was as follows:
No of shares Votes % Share capital %
Series A shares 900,000 20.79 6.95
Series B shares 26,600 0.03 0.21
Distribution of holdings:
Pentti Sipponen: 900,000 Series A shares and 14,300 Series B
shares.
Patolab Oy: 12,300 Series B shares.
The date of change in holdings was 21 June 2006.
Equity Turnover and Price Development
During the reporting period, the total turnover of Biohits B-
shares on the Helsinki Exchange NM list amounted to EUR 2,498,611
and the number of shares traded was 1,072,170. The highest share
price was EUR 2.61 and the lowest EUR 2.00, the average price
being EUR 2.33. The closing price at the end of the reporting
period was EUR 2.22. On 30 September 2006, the market
capitalisation value for the B shares totalled EUR 21,035,163.
Dissolution of the share premium fund
The National Board of Patents and Registration of Finland granted
permission for the dissolution of the share premium fund on 20
September 2006. The Annual General Meeting (AGM) of Biohit held on
20 April 2006 decided upon a decrease of the share premium fund
with a total of EUR 12,842,314.81. EUR 612,688.29 will be used for
the direct covering of a loss shown on an adopted balance sheet
(for FY 2005), and EUR 12,229,626.52 will be transferred to a fund
included in the company's non-restricted equity.
Outlook for 2006
According to the companys estimates, net sales of both liquid
handling and diagnostics products will be greater than last year.
Full-year net sales growth will not, however, reach the targets
originally set.
Slower than expected net sales growth, as well as an increase in
fixed costs and outlays on sales and marketing, will be reflected
unfavourably in full-year earnings. Contrary to earlier estimates,
the Groups result is expected to remain in the red, and the loss
to be greater than in 2005.
Accounting principles for the interim report
This interim report has been prepared in accordance with IFRS
(International Financial Reporting Standards), using IFRS
recognition and measurement principles. This interim report does
not comply with all of the requirements of IAS 34 (Interim
Financial Reporting).
All the figures in the interim report have been rounded up or
down, due to which the sums of figures may deviate from the sum
total presented.
Consolidated income statement
1-9 1-9 1-12
2006 2005 Change Change 2005
MEUR MEUR MEUR % MEUR
Net sales 22.7 20.3 2.4 12 28.7
Other operating income 0.0 0.0 0.0 -19 0.1
Change in inventories of
finished goods and work in
progress 0.9 0.5 0.5 93 0.4
Raw materials and consumables -4.4 -3.6 0.8 22 -5.1
External services -1.1 -0.7 0.4 52 -1.0
Employee benefit expenses -9.3 -8.5 0.8 9 -11.6
Depreciation -1.3 -1.3 0.1 6 -1.7
Other operating expenses -7.6 -7.1 0.5 7 -9.8
Operating profit / loss -0.0 -0.3 0.3 92 0.0
Financial expenses (net) -0.3 -0.1 0.2 284 -0.2
Profit / loss before tax -0.4 -0.4 0.1 13 -0.2
Income taxes -0.3 -0.1 0.3 526 0.0
Profit / loss for the period -0.7 -0.5 -0.2 -47 -0.2
7-9 7-9
2006 2005 Change Change
MEUR MEUR MEUR %
Net sales 7.5 6.7 0.7 11
Other operating income 0.0 0.0 0.0 124
Change in inventories of
finished goods and work in
progress 0.4 0.4 0.0 4
Raw materials and consumables -1.6 -1.3 0.3 23
External services -0.4 -0.2 0.1 64
Employee benefit expenses -2.8 -2.5 0.3 11
Depreciation -0.5 -0.5 0.0 1
Other operating expenses -2.3 -2.3 0.0 0
Operating profit / loss 0.3 0.2 0.1 21
Financial expenses (net) -0.1 -0.1 0.0 16
Profit / loss before tax 0.2 0.2 0.0 24
Direct taxes -0.2 0.0 0.2 1177
Profit / loss for the period 0.0 0.1 -0.2 -130
Group net sales by business segment
1-9 1-9
2006 2005 Change Change
MEUR MEUR MEUR %
Liquid handling 21.4 19.3 2.0 11
Diagnostics 1.3 1.0 0.3 32
Group operating result by business segment
1-9 1-9
2006 2005 Change Change
MEUR MEUR MEUR %
Liquid handling 1.7 1.6 0.1 4
Diagnostics -1.7 -1.9 0.2 12
Consolidated balance sheet
30.9.2006 30.9.2005 31.12.2005
MEUR % MEUR % MEUR %
Assets
Non-current assets
Tangible assets 6.8 25 6.5 28 6.7 24
Goodwill 2.6 10 2.6 11 2.6 9
Other intangible
assets 1.5 5 1.6 6 1.6 6
Deferred tax assets 2.0 7 1.9 8 2.1 8
Total non-current
assets 12.9 47 12.6 53 13.0 47
Current assets
Inventories 5.6 20 4.7 20 4.6 16
Trade and other
receivables 7.4 27 5.4 23 8.5 31
Cash and cash
equivalents 1.5 5 1.0 4 1.8 6
Total current
assets 14.4 53 11.1 47 14.9 53
Total assets 27.3 100 23.7 100 27.9 100
Equity and
liabilities
Share capital 2.2 8 2.2 9 2.2 8
Share premium fund 0.2 1 12.8 55 13.0 47
Non-appropriate
equity fund 12.2 45 0 0 0 0
Retained earnings -1.1 -4 -1.2 -5 -0.9 -4
Total equity 13.5 49 13.8 59 14.3 51
Non-current
liabilities
Interest-bearing
liabilities 6.5 24 4.3 18 7.7 28
Deferred tax
liabilities 0.1 0 0.1 0 0.1 0
Pension obligations 0.1 0 0.1 0 0.1 0
Other liabilities 1.5 5 0.6 3 0.6 3
Total non-current
liabilities 8.2 30 5.1 21 8.5 31
Current liabilities
Trade and other
payables 4.9 18 4.1 17 4.2 15
Current interest-
bearing liabilities 0.8 3 0.7 3 0.9 3
Total current
liabilities 5.6 21 4.8 20 5.1 18
Total liabilities 13.8 51 9.9 41 13.6 49
Total equity and
liabilities 27.3 100 23.7 100 27.9 100
Consolidated cash flow statement
1-9/2006 1-9/2005 1-12/2005
MEUR MEUR MEUR
Cash flow from operating
activities:
Profit / loss before tax -0.4 -0.4 -0.2
Adjustments 1.5 1.5 1.9
Change in working capital -0.6 -0.4 -0.8
Interest and other financial
items paid -0.1 -0.2 -0.3
Interest received 0.1 0.1 0.1
Income taxes paid -0.1 0.0 -0.1
Net cash flow from operating 0.4 0.6 0.6
activities
Cash flow from investment
activities:
Investments in tangible and
intangible assets -1.2 -1.0 -1.7
Investments in funds and
deposits -3.4
Capital gain from
investments in funds and
deposits 2,1
Net cash flow from
investment activities 0.9 -1.0 -5.1
Cash flow from financing
activities:
Proceeds from loans 0.1 0.8 4.8
Repayment of loans -0.6 -0.7 -1.0
Net cash flow from financing
activities -0.5 0.1 3.8
Increase (+) / decrease (-)
in cash and cash equivalents 0.8 -0.3 -0.6
Cash and cash equivalents at
beginning of period 0.7 1.3 1.3
Cash and cash equivalents at
end of period 1.5 1.0 0.7
Consolidated statement of changes in equity on 30 September 2006
MEUR Share Share Trans- Non- Earnings Equity
capital premium lation appropria
fund diff. te equity
fund
Equity 1 Jan 2006 2.2 13.0 0.2 0.0 -1.1 14.3
Transfer from Share
Premium Fund -12.8 12.2 0.6 0.0
Translation
differences -0.1 -0.1
Profit/loss for the
period -0.7 -0.7
Equity 30 Sep 2006 2.2 0.2 0.1 12.2 -1.1 13.5
Consolidated statement of changes in equity on 30 September 2005
MEUR Share Share Trans- Earnings Equity
capital premium lation
fund diff.
Equity on 1 Jan 2005 2.2 13.1 0.0 -1.2 14.1
Transfer from Share
Premium Fund -0.3 0.3
Translation differences 0.2 0.2
Profit/loss for the period -0.5 -0.5
Equity on 30 Sep 2005 2.2 12.8 0.2 -1.4 13.8
1-9/06 1-9/05 Change Change % 1-12/05
Investments, gross, MEUR 1.4 1.4 0.0 -14 2.0
% of net sales 5.9 6.7 7.0
Average number of
employees 302 297 5 1.7 295
Collateral, contingent liabilities and other commitments
30.9.2006 30.9.2005 31.12.2005
MEUR MEUR MEUR
Mortgages and pledged assets
Loans from financial
institutions 1.8 2.4 2.3
Corporate mortgages 1.8 1.6 1.6
Mortgages on real estate 1.4 1.4 1.4
Other long-term liabilities 0.5 0.6 0.5
Mortgages on real estate 0.8 0.8 0.8
Leasing commitments 4.6 3.6 3.8
30.9.2006 30.9.2005 31.12.2005
Key ratios
Equity ratio % 49.7 58.5 51.5
Earnings per share, EUR -0.05 -0.04 -0.02
Shareholders equity per
share 1.05 1.07 1.10
Average number of shares 12,937,627 12,937,627 12,937,627
Number of shares at the end
of period 12,937,627 12,937,627 12,937,627
The figures in the Interim Report are not audited.
Helsinki on 3 November 2006
Board of Directors of Biohit Oyj
Distribution:
Helsinki Exchanges
Financial Supervisory Authority
Press
http://www.biohit.com
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
About GastroPanel and GastroView
In the diagnostics business, Biohit focuses on the research,
development, production and marketing of products for the
screening, prevention and diagnosis of diseases of the
gastrointestinal tract. The companys diagnostic products include
the GastroPanel examination performed on a blood sample
(biomarkers: Pepsinogen-I, Pepsinogen-II, Gastrin-17, and
Helicobacter pylori antibodies), for the diagnosis of upper
abdominal complaints (dyspepsia), H. pylori infection, atrophic
gastritis and the associated risks (gastric cancer, vitamin B12
deficiency and peptic ulcer disease). In addition, GastroPanel
reveals the risk of gastroesophageal reflux disease. The company
also provides biopsy specimen quick tests for the diagnosis of
lactose intolerance and H. pylori infection. Its diagnostic
products are combined with pipettors, analysis instruments and the
related software in offering a comprehensive analysis system for
research and clinical diagnostics.
Alongside the GastroPanel examination, Biohit has developed and
submitted a patent application for the easy-to-use and cost-
effective GastroView examination. In the GastroView examination,
three biomarkers are measured from a sample of blood taken from
the fingertip: Pepsinogen I and Pepsinogen II, and Helicobacter
pylori antibodies.
Samples for the GastroView examination can be taken around the
clock, and specimens can be straightforwardly stored and sent.
With regard to both its price and the data it provides, GastroView
is a safer and more recommended option for those suffering from
dyspepsia than, for example, solely an H. pylori breath or faecal
antigen test. Unlike GastroView and GastroPanel, these tests are
not reliable indicators of H. pylori infection, and cannot
diagnose either atrophic gastritis or the related risks of gastric
cancer and vitamin B12 deficiency (www.biohit.com / Diagnostics /
Literature, Suovaniemi O. GastroPanel dyspepsian, helikobakteeri-
infektion ja atrofisen gastriitin ja siihen liittyvien riskien
turvallisen tutkimus- ja hoitokäytännön kehittämiseen,
Yksityislääkäri 2006; 5 (In English).). A GastroPanel examination
is recommended if it is possible for a sample to be taken first
thing in the morning after a night of fasting, and if the sample
can be taken, stored and sent to the laboratory according to the
instructions (www.biohit.com / Diagnostics / Service Laboratory/
Instructions for GastroPanel sample collection).
For the GastroView examination, a blood sample of at least 150 µl
(0.15 ml) must be drawn from the fingertip into an EDTA capillary
tube (Microvette CB 300K2E, Tamro). The tube can then be sent to
Biohits service laboratory for analysis. Another option is for
about 2.0 ml of venous blood to be drawn into an EDTA tube. The
blood samples required for the GastroView examination can be
stored at room temperature for at least a week and do not require
refrigerated transportation. The recommended price for patients of
the GastroView test, including GastroSoft interpretation of the
results, is EUR 90 excluding VAT (3 tests at EUR 30 per test).
KELA (The Social Insurance Institution of Finland) will refund
about EUR 49 if the patient has been prescribed a GastroView test
by a doctor (test and KELA code: Pepsinogen I, 2464, Pepsinogen
II, 2465 and Helicobacter pylori IgA&IgG antibodies, 3950).
Patients will be charged EUR 120 (0% VAT) for the GastroPanel
tests (Gastriini-17, 4639, Pepsinogen I, 2464, Pepsinogen II, 2465
and Helicobacter pylori IgA&IgG antibodies, 3950). KELA will
refund approximately EUR 67 if these tests have been prescribed by
a doctor.
Reference values and interpretation of the GastroView tests
The reference values for the GastroView tests are:
1) Pepsinogen I (PG I) 30-120 µg/l,
2) Pepsinogen II (PG II) 3-10 µg/l, PG I and PG II ratio 320, and
3) H. pylori antibodies (HPAB) 0-30 EIU.
1. Below reference PG I value, and/or PGI/PGII ratio, indicates
atrophy of the corpus of the stomach (atrophic gastritis), which
is usually caused by a current or treated H. pylori infection.
More rarely, an autoimmune disease could be the reason for the
atrophy. With corpus atrophic gastritis, the risk of gastric
cancer rise, and the risks associated with high levels of
homocysteine and vitamin B12 deficiency should also be noted.
N.B. The H. pylori breath and stool antigen tests still
extensively used in Finland do not diagnose atrophic gastritis,
and furthermore do not identify an H. pylori infection in 40-50%
of patients with atrophic gastritis, MALT lymphoma (lymphoma is a
cancer, localised gastric lymphoma may be completely cured after
H. pylori eradication treatment), bleeding peptic ulcers, or those
who are taking antibiotics or PPIs (proton pump inhibitors).
2. Below reference PG I value indicates a low-acid or anacidic
stomach. Above reference PG I value indicates increased acid
secretion, and possibly complications caused by gastroesophageal
reflux disease and/or the use of PPIs.
3. Above reference PG II value indicates inflammation that can be
due to bacteria. High PG II value also indicates the use of non-
steroid anti-inflammatory drugs (e.g. Aspirin) or abundant
quantities of strong alcoholic drinks.
4. a) If eradication treatment has not been performed, an above
reference HPAB value indicates H. pylori infection. The patient
should agree with his or her own doctor on eradication treatment
or other examinations. If eradication treatment is not carried
out, monitoring of the mucous membrane of the stomach is
recommended with GastroPanel, or with gastroscopy and biopsy
examinations.
b) If an H. pylori infection has been recently treated, the
antibody level (HPAB) may still be above reference, even if the
treatment was successful. Monitoring antibody levels (HPAB) with
GastroPanel ensures successful treatment.
5. When GastroView values are within reference values, the patient
does not have an H. pylori infection and the mucous membrane of
the corpus of the stomach is healthy and functioning normally. If
the patient is, however, suffering from stomach pains, this
probably indicates functional dyspepsia. Such complaints may also
stem from other reasons than complications caused by
gastroesophageal reflux disease or a disease of the mucous
membrane of the corpus of the stomach.
About GastroMate project
Liquid handling products, diagnostic tests, analysers and the
related software marketed by Biohit provide analysis systems for
research use and clinical diagnosis. Worldwide, hundreds of
thousands of analysers are based on vertical photometry that can
be used in a similar fashion to the analysers marketed by Biohit
in performing, for example, GastroPanel tests. GastroPanel tests
can also be used to round out the test ranges in analysis systems
provided by large international diagnostics companies. These
expensive, large capacity analysis systems are not suitable for
decentralised laboratory diagnostics. To supplement the current
analysis systems, Biohit is developing a user-friendly automatic
analyser for private clinics, health centres, emergency rooms and
special analyses. This analyser would support decentralised
laboratory diagnostics, and therefore promote both more rapid
diagnoses during doctors appointments and the likelihood of
receiving the correct treatment (evidence-based medicine).
Tekes (the Finnish Funding Agency for Technology and Innovation)
has awarded a grant to the GastroMate analyser development
project, which was begun in 2004. GastroMate performs the
GastroView and GastroPanel tests on blood samples. GastroSoft
software then evaluates and creates a report on the test results,
as well as saving them for later use. By the end of November, a
prototype will have been completed and testing may start. The
GastroMate analyser, which will be completed by the end of 2007,
utilises the globally used vertical measurement principle
(www.google.com / osmo suovaniemi vertical measurement principle),
as well as more recent innovations. The company has existing clean
room facilities for GastroMate reagents, and these facilities can
be expanded if required. Biohit manufactures its own GastroMate
analysers, although production could be outsourced if necessary.
GastroMate can be adapted to perform a variety of immuno-
diagnostics and Biohits aim is to expand its test and panel range
to the screening and diagnostics of other diseases of the
gastrointestinal tract. This area is the focus of the Diagnostics
Business. The test and panel reagents used by GastroMate in, for
example, GastroPanel are consumables that only Biohit and its
authorised distributors can sell. When purchasing the GastroMate
analyser, customers agree to use these reagents. The greater the
increase in decentralised laboratory diagnostics around the world,
- which benefits both doctors and patients and makes health care
more cost-effective - the greater the demand for GastroMate-type
analysers.
In this area, there are plenty of individual tests to be performed
(such as blood sugar and cholesterol levels), plus a smaller
number of panels (Mitsubishis Pathfast and Randoxs Evidence,
for example). Typical GastroMate customers are private clinics and
small and medium-sized laboratories.
Private clinics are GastroMates largest customer group and it is
estimated that there are 100,000 such clinics in Japan, 70,000 in
Germany and 50,000 in Italy. As well as wanting to improve the
level of diagnosis and treatment they offer, such clinics housing
either one or several doctors also try to increase their
practices profits by performing their own laboratory diagnoses.
This constitutes another way of encouraging patient loyalty.
The market price of GastroMate is estimated at EUR 8,000-10,000
while the reagent required for one GastroPanel examination costs
around EUR 20 EUR 15 for GastroView. Private clinics charge
patients between EUR 120 and 140 for GastroPanel and about EUR 90
for GastroView. The project has estimated that one doctor or
assistant nurse will carry out an average of 1,000 GastroPanel or
GastroView examinations per year.
The elimination of carcinogenic acetaldehyde from foodstuffs and
the gastrointestinal tract
In emerging countries, alcohol and tobacco pose the greatest risks
of cancers of the upper gastrointestinal tract. Other risk factors
in addition to tobacco can also be found in underdeveloped
countries, such as high consumption of vegetables preserved using
fermentation processes, bad oral hygiene, and living in houses
without chimneys. On the basis of preliminary research, many
different foodstuffs that are produced using fermentation
processes have notable acetaldehyde content (100-3500µM), as well
as high alcohol content (0.12.0%). Carcinogenic levels of
acetaldehyde can be found in, for example, preserved vegetables,
yogurts, and home-brewed beer and mead.
The above theory on the causes of cancers of the gastrointestinal
tract they being either due to alcohol, tobacco, genes and
microbes, or then to acetaldehyde caused a stir among the
alcohol researchers, microbiologists and oncologists of the world
(see for example the journal of the American Society for
Microbiology, 69: 164-165, 2003). In view of this, the use of
acetaldehyde as a flavour enhancer in foodstuffs should be
reviewed. At the moment, acetaldehyde is held to be a so-called
GRAS product (generally regarded as safe).
It has long been known that smoking causes not only lung cancer
but also cancers of the upper gastrointestinal tract. Thousands of
carcinogenic compounds, including acetaldehyde, have been found in
tobacco (cigarettes). Although each cigarette is estimated to
contain only small amounts of acetaldehyde (1-10 mg), there can be
up to 10-100 times that in the smoke (Hoffmann & Hecht: Handbook
of Experimental Pharmacology 94/I, 63-102, 1990). When smoking,
the acetaldehyde content of saliva is 200-400mM. According to the
latest research, 100 mM of acetaldehyde is already a mutagen.
Levels of acetaldehyde in saliva fall quite rapidly to zero after
tobacco has been smoked, and the fresh saliva secreted by the
salivary gland does not contain significant amounts of
acetaldehyde. Although the mouth is only exposed to acetaldehyde
for about 5 minutes at a time, the exposure of the throat,
esophagus and even the stomach is longer, as the acetaldehyde is
carried downwards with the saliva. According to research conducted
by epidemiologists, smoking can, in addition to cancer of the
esophagus, also increase the risk of gastric cancer.
Atrophic gastritis is a disease in which the mucous membrane of
the stomach has atrophied and can therefore no longer secrete
sufficient quantities of the hydrochloric acid that keeps the
contents of the stomach distinctly acidic. One of the tasks of
stomach acid is to destroy the microbes that are carried into it
in spit and food. Microbes are able to live and multiply in an
anacidic stomach, and are also able to generate energy by
producing alcohol. During this process, acetaldehyde and ethanol
are endogenetically produced as by-products from carbohydrates.
Medication for peptic ulcers and gastroesophageal reflux disease
(histamine-2 receptor antagonists and proton pump inhibitors,
PPIs) can also raise the pH of the stomach high enough for
bacterial growth and acetaldehyde production to occur.
During the review period, Biohit revealed its plans to bring to
market new products and procedures for preventing the risks of
gastrointestinal cancers. The company has, in co-operation with
Professors Mikko Salaspuro and Martti Marvola and their teams,
developed products and procedures to eliminate carcinogenic
(cancer-causing) acetaldehyde. Biohit has made patent applications
for XyliCyst, BioCyst and BioFood method.
The results of this research were presented in Italy at a congress
on oral cancer, and most recently at an international symposium
held in Sannäs (Etiology and prevention of digestive tract
cancers, XV Medical symposium of the Yrjö Johansson Foundation, 9-
11 August 2006, Sannäs, Porvoo, Finland). During the review period
Biohit has completed a prototype for XyliCyst chewing gum, and the
company is currently seeking manufacturers and distributors.
XyliCyst eliminates the acetaldehyde in the mouth that is formed
from alcohol or dissolved from tobacco into saliva.
There are around a billion smokers in the world, and around two
million people per year develop cancers of the upper
gastrointestinal tract that are primarily caused by smoking and
alcohol consumption. Licences are being offered to the food
industry for both XyliCyst and the BioFood method. The BioFood
method eliminates the carcinogenic acetaldehyde contained in many
food substances, such as yogurt and beer.
Biohit has also been focusing on the development of its BioCyst
nutritional supplements (such as capsules), which rid low-acid or
anacidic stomachs of the carcinogenic acetaldehyde produced by
oral bacteria from sugars, carbohydrates and alcohol. Corpus
atrophic gastritis and the resulting anacidic stomach can be
diagnosed using Biohits GastroPanel and GastroView examinations.
If a patient has an anacidic stomach caused by atrophic gastritis
or PPIs (proton pump inhibitors), taking BioCyst nutritional
supplements with every meal is an economical way of eliminating
any acetaldehyde that has formed in the stomach or the large
intestine. About 300 to 500 million people in the world are
estimated to have anacidic or low-acid stomachs in which oral
bacteria can live and produce carcinogenic acetaldehyde.
The BioCyst project has applied for support from Tekes. It will
take about three years to bring BioCyst products to market, but it
may be possible to implement the project more quickly if Biohit
finds a powerful partner, such as a pharmaceutical company that
manufactures and markets PPIs. BioCyst products would be an
economical partner for PPIs, and it would also be necessary to
perform a GastroPanel or GastroView test before PPI medication. In
this way, any possible ill effects from PPIs one of the most
sold medicines in the world could be prevented, and they could
be prescribed more precisely and effectively. This would have a
major, positive impact on the safety and cost-effectiveness of
health care. BioCyst products can be marketed by, for example,
chemists (in the UK there are over 10,000 chemists belonging to
1,000-1,500 chains) as well as chains and companies that market
and sell nutritional supplements and similar products.
