GastroPanel
Innovation
Pentti Sipponen, MD, PhD
Professor
Biohit Oyj, Helsinki
GastroPanel for the unmet need (1)
Gastrointestinal disorders are
 a growing medical, ethical and
economic global problem
 and they are among the most common
types of complaints made to primary
care physicians worldwide
 and are associated with a substantial
healthcare and economic burden
GastroPanel for the unmet need (2)
Despite being one of the world’s largest
therapeutic areas
 many of the diseases of the
gastrointestinal tract are still poorly
understood
 and diagnosis and therapy options are
far from optimal
 leaving many patients dissatisfied with
their current treatment
GastroPanel for the unmet need (3)
In addition, the ageing of the population is
accompanied by severe diseases
 such as gastric, oesophageal and colorectal
cancers as well as peptic ulcers, dementia,
depression, polyneuropathy, heart attacks,
strokes, anemia and osteoporosis
 which are causing an increasing burden for
well-being
 and even a threat to sustainable health care
GastroPanel for the unmet need (4)
Biohit’s mission is to alleviate and solve these
huge medical and economic problems
 and to become a leading supplier of unique
diagnostic products and analyzing systems
 as well as turnkey, comprehensive
GastroPanel Laboratories
 with special focus on the development of safe,
ethical and cost-efficient diagnosis of diseases
and cancer prevention of the gastrointestinal
tract (www.biohit.com/Diagnostics/Product Brochures
/GastroPanel Laboratories)
Dyspepsia and the physician
The prevalence of dyspepsia is 20-40% of whole
population
 Dyspepsia is not a specific symptom
 Correct diagnosis is not possible by symptoms
alone
 Gastroscopy with biopsies or GastroPanel are
the only diagnostic alternatives of very often
symptomless atrophic gastritis (loss of glands
and function of the stomach mucosa) caused by
H.pylori infection or autoimmune disease
 GastroPanel blood tests will help in
rationalizing of the endoscopic investigations
GastroPanel
Simple and reliable blood biomarker examination
for primary care
 Safe, ethical cost-efficient stomach health test
 Non-radioactive ELISA tests based on highly
specific monoclonal antibodies - assays can be
automatized avoiding human errors
 GastroPanel: pepsinogens I and II, amidated
gastrin-17, and H.pylori antibodies
 Dyspetic patients: Enable reliable diagnosis of
“healthy” stomach mucosa, H.pylori gastritis
and atrophic gastritis with related risks, such as
gastric and oesophageal cancer
GastroPanel
Primary examination
for physicians at
Basic Health Care
Biohit GastroPanel Examination –
“Genuine Laboratory Test”
Esophagus
Pepsinogen I or Pepsinogen I /II biomarkers of corpus (oxyntic
mucosa)
Corpus
Gastrin - 17 - biomarker of
antrum (antral G cells)
Pylorus
Antrum
H.pylori antibodies - biomarker of
gastritis
Venous blood sample. Sample needs centrifugation and
stabilizer
Gastrin – Acid – Feedback Control
Mechanism
+
Amidated
gastrin-17
Oxyntic
(corpus) glands
Acid
Antral (pyloric)
D and G cells
Food proteins
+
-
Atrophic corpus gastritis: Low acid output
and low serum pepsinogen I
GastroSoft computer
program helps and
assists in interpretation
of the GastroPanel data
Healthy, normal stomach: No risk of gastric
disorders. Gastroscopy does not give additional
information from stomach.
Non-atrophic H.pylori (Hp+) gastritis: High
ulcer risk, low cancer risk. Gastroscopy may be
helpful – decision by patient and physician.
Atrophic gastritis (Hp+ or Hp-): High cancer
risk, low ulcer risk. High risk of malabsorption
of vitamin B12, calcium, iron and zinc.
Unexpected malabsorption of pharmaceutical
drugs. Stomach is acid-free – will be colonized
with bacteria and fungi from oro-pharynx and
gut. Gastroscopy is mandatory.
Healthy, normal stomach:
All biomarkers are normal.
Non-atrophic H.pylori (Hp+) gastritis:
Only H.pylori antibody test is positive.
Atrophic gastritis (AG) - (Hp+ or Hp-):
Mild AG:
Moderate AG:
Severe AG:
PGI (mg/L) and/or PGI / PGII
50 - <70
5 - <7
30 - <50
3 - <5
<30
<3
Atrophic gastritis is limited to corpus alone if gastrin-17 is 10 pmol/L
or more, otherwise atrophic gastritis is in both antrum and corpus
(highest known risk condition for gastric cancer!)
Healthy, normal stomach: Immediate
gastroscopy is unnecessary because the
risks of gastric diseases are practically
non-existing.
Non-atrophic H.pylori (Hp+) gastritis:
Patient and physician may decide of
further treatment and examinations.
Consider eradication of H.pylori!
Atrophic gastritis (Hp+ or Hp-):
Gastroscopy is mandatory because of the
cancer risk. Eradication of H.pylori is
necessary if present.
GastroPanel examination
Healthy Stomach
No risks –
gastroscopy
not the first
option
H.pylori gastritis
Treatment of
H.pylori and
gastroscopy
optional
Atrophic gastritis
Gastroscopy
necessary
Developing populations (age 50 or more):
30%
50%
Developed populations (age 50 or more):
70%
25%
20%
5%
GastroPanel examination.
“China study” on 81 patients
Healthy Stomach
No risks –
gastroscopy
not the first
option
9 (11%)
H.pylori gastritis
Treatment of
H.pylori and
gastroscopy
optional
27 (33%)
Atrophic gastritis
Gastroscopy
necessary
Mild: 34 (42%)
Moderate: 8 (10%)
Severe: 3 (4%)
”Kalixanda” population sample from Sweden (Agreus
et al). Overall accuracy of GastroPanel 85%.
______________________________________________________________
Endoscopy histology (N of cases)
Normal
H.pylori
gastritis
Atrophic
gastritis
Total
Normal
541
34
4
579
H.pylori
gastritis
64
255
24
343
Atrophic
gastritis
5
15
34
54
610
304
62
976
GastroPanel
Total
GastroPanel - examples
H.pylori
EIU
G-17
pmol/l
PGI
microg/l
PGII
microg/l
<30
2-15
>30
<15
29
363
5
3.5
Antrum
Corpus
N
A3
Severe atrophic gastritis in gastric corpus

PGI is low indicating that corpus is severely atrophic. This
conclusion is supported by low PGI/PGII ratio and high G-17.

Amidated G-17 is high indicating that antrum in normal

No H.pylori antibodies. H.pylori infection is lost or atrophic gastritis
is “autoimmune” of origin.

Gastroscopy is mandatory for cancer risk. Risks of malabsorption
of vitamin B12, calcium (risk of osteoporosis), iron and zinc.
Stomach is likely totally achlorhydric (no acid).
GastroPanel - examples
H.pylori
EIU
<30
2
G-17
pmol/l
PGI
microg/l
PGII
microg/l
2-20
>30
<15
18
75
10.1
Antrum
Corpus
N
N
Stomach mucosa is normal and healthy

All GastroPanel biomarkers are normal
 Risk of cancer or peptic ulcer is nil – irrespective of age.
 Gastroscopy will not give any additional information.
Colonoscopy or other clinical examinations are more
useful.
GastroPanel examination
Healthy versus diseased (”sick” gastric mucosa):
Tohoku – Japan:
Accuracy :
Sensitivity:
Specificity:
94%
95%
93%
Atrophic gastritis versus non-atrophic gastritis
Kalixanda – Sweden:
Accuracy:
Sensitivity
Specificity
96%
71%
98%
Is stomach mucosa ”healthy” or ”sick”?
GastroPanel provides diagnosis of H.pylori infection
 but also gives the diagnosis of very often
symptomless atrophic gastritis in corpus and/or
antrum
 with related risks, such as gastric and
oesophageal cancer, peptic ulcer disease and the
deficiency of vitamin B12, iron and calcium.
 Atrophic gastritis is caused by H.pylori infection
or autoimmune disease,
 and diagnosed only by GastroPanel or
gastroscopy
GastroPanel vs. Gastroscopy
The quality of the gastroscopy is strongly
dependent on the experience and competence of
the gastroenterologist and the pathologist
 GastroPanel doesn’t have such quality
problems, irrespectively who ever does the
GastroPanel blood tests
 However, the diagnosis of atrophic gastritis
obtained with GastroPanel is in good
agreement with gastroscopy performed by
skilful gastroenterologists and pathologists
H.pylori tests alone are useless
and may result in malpractice
13C urea breath test, stool antigen test and antibody
tests do not diagnose atrophic gastritis with related
risks, such as gastric and oesophageal cancer
13C urea breath test and stool antigen test may give
even 50% of false negative results in patient with
atrophic gastritis, MALT lymphoma, bleeding peptic
ulcer or in patients with PPI or antibiotic treatments
GastroPanel does not include any of these serious
medical and ethical problems
Serious Medical and Ethical Problems




Malpractice and even unnecessary deaths, for
example, due to gastric cancer and peptic ulcer
bleedings
These serious medical and ethical problems of the
“test-and-treat strategy” can be solved simply and
economically
by omitting the 13C urea breath test, the stool antigen
test or only antibody tests
and replacing them with the GastroPanel
examination,
which provides abundant information of dyspepsia
patients and healthy people for diagnosis and
treatment
GastroPanel from blood plasma
Enables non-endoscopic diagnosis and assessment of:
 Gastritis and H.pylori (Hp) infection
 Atrophic gastritis, both Hp+ and Hp Risk for gastric and oesophageal cancer and peptic
ulcer dicease
 Risk for malabsorption of vitamin B12 (dementia,
depression, polyneuropathy), dietary calcium
(osteoporosis) and iron (iron deficiency anemia) as
well as some drugs
 Hyperacid stomach: risks of the complications of
gastroesophaceal disease, such as erosive
oesophagitis and Barrett’s oesophagus
 Healthy stomach
GastroSoft Interpretation
GastroPanel Laboratory
 All GastroPanel microplate reagents:
Pepsinogen I, Pepsinogen II, Gastrin-17
and H.pylori IgG ELISA kits
 Vertical measurement principle based
instruments; manual or automatic
 Pipettes and disposable tips
 Education and training
 After sales and service support
www.biohit.com/Diagnostics/Product
Brochures/GastroPanelLaboratories
The History of Biohit’s GastroPanel
Innovation (1)
The Finnish Gastritis Research Group, professors
Max Siurala and Pentti Sipponen, and coworkers, on chronic gastritis and atrophic
gastritis from the 70’s and 80’s
 helped professors Barry J. Marshall and J.
Robin Warren to realize that the infection and
gastritis are connected to development of
peptic ulcer diseases and stomach cancer
The History of Biohit’s GastroPanel
Innovation (2)
The Nobel Prize in Physiology or Medicine for
2005 jointly to Barry J. Marshall and J. Robin
Warren for their discovery of "the bacterium
Helicobacter pylori and its role in gastritis and
peptic ulcer disease" in 1982
(http://nobelprize.org/medicine/laureates/2005/press.html )
The History of Biohit’s GastroPanel
Innovation (3)
Professor Osmo Suovaniemi’s innovations, such as vertical
measurement principle for micoroplates and very first microplate
reader Titertek Multiskan, from the 60’s and 70’s, have
 revolutionized microplate analyses worldwide and have been utilized
so extensively and successfully since the 70’s, that they can justifiably be
called global laboratory and industrial standards (www.google.com /
Search “Osmo Suovaniemi vertical measurement principle”).
 His innovations resulted, among other things, in rapid and massive
development of reliable and safe non-radioactive microplate
immunoassays,
 on which the GastroPanel biomarker ELISA-tests (pepsinogen I and
II, gastrin-17 and Helicobacter pylori antibodies) are based
(www.biohit.com/About Us/History, www.biohit.com / Diagnostics).
Theranostic GastroPanel diagnosis
and Acetium preventive treatment
GastroPanel
 Diagnose atrophic gastritis – Acid-free stomach:
low PGI and/or low PGI/PGII and high G-17
 Acid-free stomach is a risk factor of gastric and
oesofageal cancer
Acetium capsule
 Binds and inactivates carcinogenic acetaldehyde
(class 1 carcinogen for humans/WHO-IARC Oct
2009) in an acid-free stomach caused by atrophic
gastritis or autoimmune disease
Thank You for Your Attention.