Ei dian otsikkoa

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GastroPanel Innovation Pentti Sipponen, MD,
PhD Professor Biohit Oyj, Helsinki
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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

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GastroPanel for the unmet need (2)

• Despite being one of the worlds 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

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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

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GastroPanel for the unmet need (4)

• Biohits 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)

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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

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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

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GastroPanel Primary examination for physicians
at Basic Health Care
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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
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Gastrin Acid Feedback Control Mechanism

Amidated gastrin-17
Oxyntic (corpus) glands
Acid
-
Antral (pyloric) D and G cells

Food proteins
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Atrophic corpus gastritis Low acid output and
low serum pepsinogen I
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GastroSoft computer program helps and assists in
interpretation of the GastroPanel data
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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.
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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-) PGI (mg/L)
and/or PGI / PGII Mild AG 50 -
lt70 5 - lt7 Moderate AG
30 - lt50 3 - lt5 Severe AG
lt30
lt3 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!)
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Healthy, normal stomach Immediate gastroscopy
is unnecessary because the risks of gastric
diseases are practically non-existing. Non-atroph
ic 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.
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GastroPanel examination
Healthy Stomach
H.pylori gastritis
Atrophic gastritis
Treatment of H.pylori and gastroscopy optional
No risks gastroscopy not the first option
Gastroscopy necessary
Developing populations (age 50 or more)
30 50
20 Developed populations (age 50 or
more) 70 25
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GastroPanel examination. China study on
81 patients
Healthy Stomach
H.pylori gastritis
Atrophic gastritis
Treatment of H.pylori and gastroscopy optional
No risks gastroscopy not the first option
Gastroscopy necessary
9 (11) 27 (33) Mild 34
(42) Moderate 8 (10)
Severe 3 (4)
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Kalixanda population sample from Sweden (Agreus
et al). Overall accuracy of GastroPanel 85.
_________________________________________________
_____________
Endoscopy histology (N of cases)
Normal
H.pylori Atrophic Total gastritis gastrit
is GastroPanel Normal 541 34 4 579 H.pylori 64 2
55 24 343 gastritis Atrophic 5 15 34 54 gastritis
Total 610 304 62 976
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GastroPanel - examples

• H.pylori G-17 PGI PGII
  Antrum Corpus
  EIU pmol/l microg/l microg/l
  
  lt30 2-15
  gt30 lt15
• 29 363 5
  3.5 N A3
• 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).

Severe atrophic gastritis in gastric corpus
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GastroPanel - examples

• H.pylori G-17 PGI PGII Antrum Corpus
  EIU pmol/l microg/l microg/l
  lt30
  2-20
  gt30 lt15
• 2 18 75 10.1 N N
• 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.

Stomach mucosa is normal and healthy
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GastroPanel examination
Healthy versus diseased (sick gastric
mucosa) Tohoku Japan
Accuracy 94
Sensitivity 95
Specificity
93 Atrophic gastritis versus non-atrophic
gastritis Kalixanda Sweden
Accuracy 96
Sensitivity 71
Specificity 98

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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

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GastroPanel vs. Gastroscopy

• The quality of the gastroscopy is strongly
  dependent on the experience and competence of the
  gastroenterologist and the pathologist
• GastroPanel doesnt 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

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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
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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

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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 Barretts oesophagus
• Healthy stomach

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GastroSoft Interpretation
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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

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The History of Biohits GastroPanel Innovation (1)

• The Finnish Gastritis Research Group, professors
  Max Siurala and Pentti Sipponen, and co-workers,
  on chronic gastritis and atrophic gastritis from
  the 70s and 80s
• 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

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The History of Biohits 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 )
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The History of Biohits GastroPanel Innovation (3)

• Professor Osmo Suovaniemis innovations, such as
  vertical measurement principle for micoroplates
  and very first microplate reader Titertek
  Multiskan, from the 60s and 70s, have
• revolutionized microplate analyses worldwide
  and have been utilized so extensively and
  successfully since the 70s, 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).

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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

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Thank You for Your Attention.