GI effects ®

Patient:

2200 GI Effects™ Comprehensive Profile - Stool Powered by Genova AI

Results Overview

MALDIGESTION INFLAMMATION

INFECTION DYSBIOSIS

METABOLITE IMBALANCE

Functional Imbalance Scores

Key : Low Need for Support : Optional Need for Support : Moderate Need for Support : High Need for Support

Need for Need for Need for Need for Need for
Digestive Support Inflammation Modulation Microbiome Support Prebiotic Support Antimicrobial Support
MALDIGESTION INFLAMMATION DYSBIOSIS METABOLIC IMBALANCE INFECTION

0 0 4 2 7
Products of Protein Secretory IgA PP Bacteria/Yeast Total SCFA's PP Bacteria/Yeast
Breakdown Calprotectin IAD/Methane Score n-Butyrate Conc. Parasitic Infection
Fecal Fats Eosinophil Protein X Reference Variance SCFA (%) Pathogenic Bacteria
Pancreatic Elastase Occult Blood Total Abundance Beta-glucuronidase Total Abundance

• Digestive Enzymes • Elimination Diet/ Food • Pre-/Probiotics • Pre-/Probiotics • Antibiotics

• Betaine HCl Sensitivity Testing • Increase Dietary Fiber • Increased Dietary Fiber (if warranted)
• Bile Salts • Mucosa Support: Slippery Intake Intake • Antimicrobial Herbal
• Apple Cider Vinegar Elm, Althea, Aloe, DGL, etc. • Consider SIBO Testing • Increase Resistant Therapy
• Mindful Eating Habits • Zinc Carnosine • Increase Resistant Starches • Antiparasitic Herbal
• Digestive Bitters • L-Glutamine Starches • Increase Fermented Therapy (if warranted)
• Quercetin • Increase Fermented Foods • Saccharomyces
• Turmeric Foods • Calcium D-Glucarate boulardii
• Omega-3's • Meal Timing (for high
• GI Referral (If Calpro is beta-glucuronidase)
Elevated)
© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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Commensal Microbiome Analysis

Commensal Abundance
-20% -10% +10% +20%
Patient Total Commensal Abundance Healthy Cohort
◀ ▶
Potential Microbiome Deficiency 100% Potential Microbiome Overgrowth

Total Commenal Balance: The total commensal abundance is a sum-total of the reported commensal bacteria compared to a
healthy cohort. Low levels of commensal bacteria are often observed after antimicrobial therapy, or in diets lacking fiber and/or
prebiotic-rich foods and may indicate the need for microbiome support. Conversely, higher total commensal abundance may indicate
potential bacteria overgrowth or probiotic supplementation.

Dysbiosis Patterns
29 Dysbiosis Patterns: Genova’s data analysis
Inflammation-Associated Dysbiosis (IAD) has led to the development of unique dysbiosis
60 110
patterns, related to key physiologic disruptions,
Low High
such as immunosuppression and inflammation.
1 These patterns may represent dysbiotic
changes that could pose clinical significance.
Methane Dysbiosis Score 5 16
Please see Genova’s published literature for
Low High more details: https://rdcu.be/bRhzv

Zone 1: The commensal profile in this zone

does not align with profiles associated with
intestinal inflammation or immunosuppression. If
60 inflammatory biomarkers are present, other
16
causes need to be excluded, such as infection,
food allergy, or more serious pathology.

Zone 2: This pattern of bacteria is associated

with impaired intestinal barrier function (low
fecal sIgA and EPX). Patients in this zone have
higher rates of opportunistic infections (e.g.
Blastocystis spp. & Dientamoeba fragilis ) as
5 5 well as fecal fat malabsorption. Commensal
abundance is higher in this group suggesting
potential bacterial overgrowth.

Zone 3: Patients in this zone may have more

inflammation compared to those in zone 4.
However, commensal abundance is usually
higher making use of antimicrobial therapy
relatively safer. Patients in this zone may have
60 110 higher rates of pathogenic infections.

Zone 4: This commensal profile is associated

with increased intestinal inflammation. IBD
patients are more likely to have this pattern of
bacteria. Commensal abundance is lower in this
zone; therefore, antibiotic use for GI potential
pathogens should be used with caution. In
addition to standard treatment for intestinal
inflammation, modulation of the commensal gut
profile is encouraged.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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Commensal Microbiome Analysis

Commensal Balance

You

*A progressive ranking scale based on a Genova proprietary

algorithm that differentiates healthy and unhealthy
commensal patterns.

**The total number of commensal bacteria (qPCR) that are

out of balance for this individual on a scale of 0 to >12.

Relative Commensal Abundance

-50% -25% +25%
Healthy Cohort
Increase in Bacteroides spp. and Odoribacter spp. seen in animal-based
Bacteroidetes Phylum
diets; Prevotella increased with plant-based diet
Contains many butyrate-producers; most species responsive to
Firmicutes Phylum
plant-based diets; Faecalibacterium spp. is anti-inflammatory
Bifidobacterium is increased with plant-based diets; Collinsella
Actinobacteria Phylum
may be proinflammatory, and is elevated with a Western-diet
Some species may be proinflammatory; E. coli consumes simple
Proteobacteria Phylum
sugars and is lower in individuals on plant-based diets
*** Methanobrevibacter smithii is associated with methane
Euryarchaeota Phylum NR
production and with diets high in carbohydrates
*** Certain Fusobacterium spp. may be proinflammatory and
Fusobacteria Phylum NR
increased on low fiber, high fat diets
Akkermansia spp. is involved in gut membrane integrity and
Verrucomicrobia Phylum
may be increased with polyphenols and prebiotics

Relative Abundance: The relative abundance compares the quantity of each of 7 major bacterial phyla to a healthy cohort. This can
indicate broader variances in the patient’s gut microbiome profile. Certain interventions may promote or limit individual phyla when clinically
appropriate. Please refer to Genova’s Stool Testing Support Guide for more information on modulation of commensal bacteria through diet &
nutrient interventions. ***Approximately 70% of the healthy cohort had below detectable levels of Methanobrevibacter smithii.
Approximately 90% of the healthy cohort had below detectable levels of Fusobacterium spp.

Physician Notes/Recommendations

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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2200 GI Effects™ Comprehensive Profile - Stool

QUINTILE DISTRIBUTION
1st 2nd 3rd 4th 5th
Methodology: GC-FID, Automated Chemistry, EIA Result Reference Range

Digestion and Absorption

100 200
Pancreatic Elastase 1 † >500 >200 mcg/g

Products of Protein Breakdown (Total*)

(Valerate, Isobutyrate, Isovalerate) 2.2 1.8-9.9 micromol/g

Fecal Fat (Total*) 6.6 3.2-38.6 mg/g

Triglycerides 0.7 0.3-2.8 mg/g

Long-Chain Fatty Acids 4.6 1.2-29.1 mg/g

Cholesterol 0.8 0.4-4.8 mg/g

Phospholipids 0.5 0.2-6.9 mg/g

Inflammation and Immunology

50 120
Calprotectin † <16 <=50 mcg/g
0.5 2.7
Eosinophil Protein X (EPX)† <DL <=2.7 mcg/g
680 2040
Fecal secretory IgA 683 <=2,040 mcg/mL

Gut Microbiome Metabolites

Metabolic
Short-Chain Fatty Acids (SCFA) (Total*)
(Acetate, n-Butyrate, Propionate) 29.3 >=23.3 micromol/g

n-Butyrate Concentration 6.7 >=3.6 micromol/g

n-Butyrate % 22.9 11.8-33.3 %

Acetate % 59.2 48.1-69.2 %

Propionate % 18.1 <=29.3 %

Beta-glucuronidase 1,547 368-6,266 U/g

*Total value is equal to the sum of all measurable parts.

†These results are not represented by quintile values.
Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.
© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
2200C.11
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Methodology: DNA by qPCR

Gastrointestinal Microbiome (PCR)

QUINTILE DISTRIBUTION
Commensal Bacteria (PCR) Result 1st 2nd 3rd 4th 5th Reference Range
CFU/g stool CFU/g stool
Bacteroidetes Phylum
Bacteroides uniformis 3.5E8 <=9.5E8

Phocaeicola vulgatus 2.8E8 <=8.3E8

Barnesiella spp. 3.6E7 3.0E6 -2.9E8

Odoribacter spp. <DL <=9.5E7

Prevotella spp. 1.2E9 6.6E7 -3.8E9

Firmicutes Phylum
Anaerotruncus colihominis/massiliensis 1.6E7 <=2.0E7

Butyrivibrio crossotus <DL <=3.3E7

Clostridium spp. <DL <=1.5E7

Coprococcus eutactus <DL <=1.2E8

Faecalibacterium prausnitzii 2.4E8 1.1E6 -1.1E9

Lactobacillus spp. 5.6E3 <=1.6E6

Pseudoflavonifractor spp. 1.4E6 1.3E4 -2.9E7

Roseburia spp. 7.4E7 3.6E5 -4.6E8

Ruminococcus bromii 4.6E8 <=1.5E9

Veillonella spp. 4.6E5 <=4.1E6

Actinobacteria Phylum
Bifidobacterium spp. 5.0E7 4.6E5 -2.6E8

Bifidobacterium longum subsp. longum <DL <=1.3E8

Collinsella aerofaciens <DL <=1.3E8

Proteobacteria Phylum
Desulfovibrio piger <DL <=5.4E7

Escherichia coli 2.1E4 <=7.5E6

Oxalobacter formigenes <DL <=1.1E7

Euryarchaeota Phylum
Methanobrevibacter smithii <DL <=2.0E7
Fusobacteria Phylum
Fusobacterium spp. <DL <=1.8E5
Verrucomicrobia Phylum
Akkermansia muciniphila 5.9E5 >=8.5E3

The gray-shaded portion of a quintile reporting bar represents the proportion of the reference population with results below detection limit.

Commensal results and reference range values are displayed in a computer version of scientific notation, where the capital letter “E” indicates the exponent
value (e.g., 7.3E6 equates to 7.3 x 10⁶ or 7,300,000).

The methodology for the PCR Commensal Bacteria has been updated to qPCR. The reference ranges have been updated accordingly.

The names of some of the bacteria have been updated as a result of taxonomy changes and method improvements.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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Methodology: Culture/MALDI-TOF MS, Automated and Manual Biochemical Methods, Vitek® 2 System Microbial identification and Antibiotic susceptibility

Gastrointestinal Microbiome (Culture)

Human microflora is influenced by environmental factors and the Additional Bacteria
competitive ecosystem of the organisms in the GI tract. Pathogenic
Non-Pathogen: Organisms that fall under this category are those that
significance should be based upon clinical symptoms.
constitute normal, commensal flora, or have not been recognized as
Microbiology Legend etiological agents of disease.
Potential Pathogen: Organisms that fall under this category are considered
NG NP PP P potential or opportunistic pathogens when present in heavy growth.
Pathogen: The organisms that fall under this category have a well-
recognized mechanism of pathogenicity in clinical literature and are
No Growth Non- Potential Pathogen
considered significant regardless of the quantity that appears in the culture.
Pathogen Pathogen

1+ 2+ 3+ 4+
Bacteriology (Culture)
NG
Lactobacillus spp.
4+ NP
Escherichia coli
3+ NP
Bifidobacterium (Anaerobic Culture)

Additional Bacteria

Salmonella spp. NG

Shigella spp. NG

Klebsiella pneumoniae 4+ PP

Bacillus species 1+ NP

Enterococcus faecium 4+ NP

Mycology (Culture)
Candida kruseii 2+ PP

Yeast, not Candida albicans 1+ NP

OPTIONAL ADD-ON
KOH Preparation for Yeast
Methodology: Potassium Hydroxide (KOH) Preparation for Yeast
Potassium Hydroxide (KOH) Preparation for Yeast
These yeast usually represent the organisms isolated by culture. In the presence of a negative yeast culture, microscopic yeast may reflect
organisms not viable enough to grow in culture. The presence of yeast on KOH prep should be correlated with the patient’s symptoms.
However, moderate to many yeast suggests yeast overgrowth.
The result is reported as the amount of yeast seen microscopically:
Result
Rare: 1-2 per slide
KOH Preparation, stool Rare Yeast Present Few: 2-5 per high power field (HPF)
Moderate: 5-10 per HPF
Many: >10 per HPF

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475 2200C.14
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Parasitology
Microscopic O&P Results
Microscopic O&P is capable of detecting all described gastrointestinal parasites. The organisms listed in the box represent those
commonly found in microscopic stool analysis. Should an organism be detected that is not included in the list below, it will be reported
in the Additional Results section. These results were obtained using wet preparation(s) and trichrome stained smear. For an extensive
reference of all potentially detectable organisms, please visit www.gdx.net/product/gi-effects-comprehensive-stool-test
Genus/species Result
Nematodes - roundworms
Ancylostoma/Necator (Hookworm) Not Detected
Ascaris lumbricoides Not Detected
Capillaria philippinensis Not Detected
Enterobius vermicularis Not Detected
Strongyloides stercoralis Not Detected
Trichuris trichiura Not Detected
Cestodes - tapeworms
Diphyllobothrium latum Not Detected
Dipylidium caninum Not Detected
Hymenolepis diminuta Not Detected
Hymenolepis nana Not Detected
Taenia spp. Not Detected
Trematodes - flukes
Clonorchis/Opisthorchis spp. Not Detected
Fasciola spp./ Fasciolopsis buski Not Detected
Heterophyes/Metagonimus Not Detected
Paragonimus spp. Not Detected
Schistosoma spp. Not Detected
Protozoa
Balantidium coli Not Detected
Blastocystis spp. Many Detected
Chilomastix mesnili Not Detected
Cryptosporidium spp. Not Detected
Cyclospora cayetanensis Not Detected
Dientamoeba fragilis Not Detected
Entamoeba coli Not Detected
Entamoeba histolytica/dispar Not Detected
Entamoeba hartmanii Not Detected
Entamoeba polecki Not Detected
Endolimax nana Not Detected
Giardia Not Detected
Iodamoeba buetschlii Not Detected
Cystoisospora spp. Not Detected
Trichomonads (e.g. Pentatrichomonas) Not Detected
Additional Findings
White Blood Cells Not Detected
Charcot-Leyden Crystals Not Detected
Other Infectious Findings

One negative specimen does not rule out the possibility of a parasitic infection.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475 2200C.15
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Parasitology
Methodologies: DNA by PCR
PCR Parasitology - Protozoa
Organism Result Units Expected Result

Blastocystis spp. <2.14e2 femtograms/microliter C&S stool Detected Not Detected

Cryptosporidium parvum/hominis <1.76e2 genome copies/microliter C&S stool Not Detected Not Detected
Cyclospora cayetanensis <2.65e2 genome copies/microliter C&S stool Not Detected Not Detected
Dientamoeba fragilis <1.84e2 genome copies/microliter C&S stool Not Detected Not Detected
Entamoeba histolytica <9.64e1 genome copies/microliter C&S stool Not Detected Not Detected
Giardia <1.36e1 genome copies/microliter C&S stool Not Detected Not Detected

Additional Results
Methodology: Fecal Immunochemical Testing (FIT)
Result Expected Value
Fecal Occult Blood◆ Negative Negative

Color†† Brown

Consistency†† Formed/Normal

††Results provided from patient input.

Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.

OPTIONAL ADD-ON
Zonulin Family Peptide
Methodology: EIA Result Reference Range Zonulin Family Peptide
This test is for research use only. Genova will not provide
Zonulin Family Peptide, Stool 86.0 22.3-161.1 ng/mL
support on interpreting the test results. This test does not
1
detect zonulin. The Scheffler paper suggests that the IDK
kit may detect a zonulin family peptide, such as properdin.
Genova’s unpublished data demonstrated that the current
IDK kit results were associated with stool inflammation
biomarkers and an inflammation-associated dysbiosis
profile.
The performance characteristics of Zonulin Family Peptide
have been verified by Genova Diagnostics, Inc. The assay
has not been cleared by the U.S. Food and Drug
Administration.

Reference:
1. Scheffler L, et al. Widely Used Commercial ELISA Does Not Detect Precursor of Haptoglobin2, but
Recognizes Properdin as a Potential Second Member of the Zonulin Family. Front Endocrinol. 2018;9:22.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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 Page 9

OPTIONAL ADD-ON
Macroscopic/Direct Exam for Parasites
Methodology: Macroscopic Evaluation

No human parasite detected in sample.

Add-on Testing
Methodology: EIA
Result Expected Value

HpSA - H. pylori Negative Negative

Campylobacter spp.◆ Negative Negative

Clostridium difficile◆ Negative Negative

Shiga toxin E. coli◆ Negative Negative

Fecal Lactoferrin◆ Negative Negative

Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
2200C.18
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Methodology: Vitek 2® System Microbial Antibiotic susceptibility, Manual Minimum Inhibition Concentration
Bacteria Sensitivity

Prescriptive Agents
Klebsiella pneumoniae R I S-DD S NI
Ampicillin R
Amox./Clavulanic Acid S
Cephalothin S
Ciprofloxacin S
Tetracycline S
Trimethoprim/Sulfa S
Natural Agents
Klebsiella pneumoniae LOW INHIBITION HIGH INHIBITION

Berberine

Oregano

Uva-Ursi

Prescriptive Agents:
The R (Resistant) category implies isolate is not inhibited by obtainable levels of pharmaceutical agent.
The I (Intermediate) category includes isolates for which the minimum inhibition concentration (MIC) values usually approach obtainable pharmaceutical agent
levels and for which response rates may be lower than for susceptible isolates.
The S-DD (Susceptible-Dose Dependent) category implies clinical efficacy when higher than normal dosage of a drug can be used and maximal concentration
achieved.
The S (Susceptible) column implies that isolates are inhibited by the usually achievable concentrations of the pharmaceutical agent.
NI (No Interpretive guidelines established) category is used for organisms that currently do not have established guidelines for MIC interpretation.
Refer to published pharmaceutical guidelines for appropriate dosage therapy.
Natural Agents:
In this assay, inhibition is defined as the reduction level on organism growth as a direct result of inhibition by a substance. The level of inhibition is an indicator of how
effective the substance was at limiting the growth of an organism in an in vitro environment. High inhibition indicates a greater ability by the substance to limit growth, while
Low Inhibition a lesser ability to limit growth. The designated natural products should be considered investigational in nature and not be viewed as standard clinical treatment
substances.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
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Methodology: Vitek 2® System Microbial Antibiotic susceptibility, Manual Minimum Inhibition Concentration
Mycology Sensitivity

Candida Susceptibility Profile for Azoles*

*Results of pharmaceutical sensitivities against certain yeast species are based on internal
Genova data pertaining to the frequency of susceptibility of the specific yeast to the listed
antifungal agent. The pharmaceutical results are not patient-specific. Conversely, the results of
inhibition to nystatin and natural agents are patient-specific.

Non-absorbed Antifungals
Candida kruseii LOW INHIBITION HIGH INHIBITION

Nystatin

Natural Agents
Candida kruseii LOW INHIBITION HIGH INHIBITION

Berberine

Caprylic Acid

Garlic

Undecylenic Acid

Uva-Ursi

Nystatin and Natural Agents:

Results for Nystatin are being reported with natural antifungals in this category in accordance with laboratory guidelines for reporting sensitivities. In this assay, inhibition is
defined as the reduction level on organism growth as a direct result of inhibition by a natural substance. The level of inhibition is an indicator of how effective the substance
was at limiting the growth of an organism in an in vitro environment. High inhibition indicates a greater ability by the substance to limit growth, while Low Inhibition a lesser
ability to limit growth. The designated natural products should be considered investigational in nature and not be viewed as standard clinical treatment substances.

© Genova Diagnostics · A. L. Peace-Brewer, PhD, D(ABMLI), Lab Director · CLIA Lic. #34D0655571 · Medicare Lic. #34-8475
CYSEN.2