New GI Effects Reporting Enhancements
Genova Diagnostics is pleased to announce innovative reporting enhancements to the GI Effects
Comprehensive and GI Effects Microbial Ecology stool profiles.
New Features Include:
A Commensal Balance Infographic – Designed to provide a more precise view of an individual patient's commensal bacteria (PCR) results relative to a spectrum of healthy and unhealthy commensal patterns. (See video featured below.)
Clinical Association Charts – See how patient results compare to commensal bacteria (PCR) and biomarker patterns seen in patients with specific clinical conditions:
- Metabolic Syndrome
- Chronic Fatigue
- Autoimmune dysfunction
- Type 2 Diabetes
- High Blood Pressure
- Mood Disorders
Correlations are now evident between many disease processes and patterns of microbiome dysbiosis in both gut dysfunction and extra-intestinal disorders.
Video Overview of the Reporting Enhancements
Displayed in an expanded Interpretation At-a-Glance section, the new report enhancements provide informative data derived from Genova Diagnostics patient results archive. All results were obtained with the same Genova Diagnostics technology platform(s); this allows for an equivalent or 'like to like' comparison of an individual patient's results to various clinical conditions.
Gastrointestinal function is critical for good health. Emerging evidence in the scientific literature has associated gut microbiome status with a wide variety of common illnesses.
What is the GI Effects Comprehensive Stool Profile?
GI Effects is an innovative stool test measuring premier biomarkers of gastrointestinal function, providing valuable clinical insight into digestive performance, gut inflammation, and the gut microbiome — areas affecting not only GI health, but overall health as well.
The sophisticated biomarkers from the GI Effects Comprehensive Profile are reported using an intuitive DIG framework, providing key clinical information for three main gastrointestinal functional areas:
- Pancreatic Elastase-1, a marker of exocrine pancreatic function
- Products of Protein Breakdown, markers of undigested protein reaching the colon
- Fecal Fat, markers of fat breakdown and absorption
- Calprotectin, a marker of neutrophil-driven inflammation; produced in abundance at sites of inflammation, this biomarker has been proven clinically useful in differentiating between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)*
- Eosinophil Protein X, a marker of eosinophil-driven inflammation and allergic response
- Fecal Secretory IgA, a marker of gut secretory immunity and barrier function
- Additional biomarkers available: Fecal Lactoferrin
- Gut Microbiome:
- Metabolic indicators, demonstrating specific and vital metabolic functions performed by the microbiota
- Short-Chain Fatty Acids, a metabolomic indicator of GI microbiome health
- Beta-glucuronidase, an inducible enzyme involved in the metabolism and bioavailability of food and drug compounds; also produced by gut bacteria
- Commensal Bacteria, demonstrating the composition, diversity, and relative abundance of gut organisms, all of which are linked to both gastrointestinal and general health
- More than 95% of commensal gut organisms are anaerobic and are difficult to recover by traditional (aerobic) culture techniques; molecular DNA techniques are now considered the standard for anaerobic bacteria assessment in research, permitting identification and quantification of multiple organisms with a single specimen.
- The Polymerase Chain Reaction (PCR) methodology can identify bacterial populations at any level of taxonomy, as broadly as phylum and as narrowly as species. This ability permits analysis of the gut microbiome at a desired degree of complexity.
- GI Effects assesses a key set of 24 clinically relevant genera/species that map to 7 major phyla.
- Bacterial and mycological culture, which demonstrate the presence of specific beneficial and pathological organisms
- Traditional bacterial culture complements DNA-based tests to provide an expanded survey of a patient's gut microbiota, beyond the specific organisms targeted by PCR.
- GI Effects provides microscopic examination of fecal specimens for ova and parasites (O&P), the gold standard of diagnosis for many parasites.
- Enzyme immunoassay (EIA), widely recognized for its diagnostic utility in the detection of pathogenic antigens, is used for the identification of Cryptosporidium, Entamoeba histolytica, and Giardia lamblia.
- Determination of one-day or three-day sample collection is based on clinician's clinical index of suspicion for parasitic infection. If no/low suspicion, a one day sample will likely be adequate. If high suspicion, a three day sample collection is optimal.
- Additional Biomarkers Available:
- Clostridium difficile
- Escherichia coli
- Fecal Lactoferrin
- Helicobacter pylori
- Macro Exam for Worms
- Stool Zonulin
- KOH Preparation for Yeast
When Should the GI Effects Comprehensive Stool Profile Be Considered?
GI Effects assesses three critical areas of gut health: digestive function, gut inflammation, and the gut microbiome—areas affecting not only GI health, but overall health as well. For patients with symptoms that may have gastrointestinal dysfunction as their root cause, comprehensive stool diagnostics provide an effective tool for gaining clinical insight into next steps.
In addition to performing critical digestive functions, the intestinal tract contains significant amounts of organisms — the gut microbiome. Imbalances in this internal ecosystem have been associated in the scientific literature with a wide variety of common illnesses.
Assessing and normalizing GI function can have profound effects on overall health, leading to improvement in these and other conditions. The GI Effects® Comprehensive Stool Profile is a critical clinical tool in the management of patients presenting with symptoms that can be associated with compromised gut health.
What Advantage Does the Profile Offer Compared to Other Diagnostics?
GI Effects® represents the best technical platform to assess gut health, including an optimized PCR molecular assay for anaerobic bacteria, Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) technology for identification of cultivable species, as well as premier biomarkers for stool-based gastrointestinal diagnostics.
The test report is organized so that the clinician may move through results in a logical order that enhances clinical utility, starting with an innovative Interpretation-At-A-Glance pages that are comprised of the following:
- Functional Pillars – Using evidence-based rules and weighted algorithms, this page synthesizes patient test results into Functional Pillars of clinical significance (Infection and Imbalance) and provides a directional indication of potential therapeutic next steps in patient management.
- Commensal Balance – this infographic has been designed to provide a more precise view of an individual patients' commensal bacteria (PCR) results relative to a healthy cohort. It is composite of two measures:
- The Healthy-Pattern Continuum (formerly known as the Diversity Association Index) is a progressive ranking scale based on a Genova proprietary algorithm that differentiates healthy and unhealthy commensal patterns. This algorithm is applied to an individual patient's GI Effects commensal bacteria (PCR) findings, and produces a numeric result ranging from 0 to 10 and is denoted by the 'y' axis of the Commensal Balance infographic.
- The Reference Variance Score reflects the total number of an individual patient's commensal bacteria (PCR) results that are out of reference range. This number ranges from zero to 24, and is denoted by the 'x' axis of the Commensal Balance infographic.
- Relative Abundance – this infographic represents the proportional levels of select phyla in an individual's microbiome and is represented relative to similar measures derived from a healthy cohort of individuals.
- Commensal and Biomarker Clinical Associations Charts – to create these charts, Genova utilized the GI Effects test-results database which allowed comparison of commensal and biomarker results in patients with self-reported clinical conditons (IBD, Metabolic Syndrome, Chronic Fatigue, Autoimmune dysfunction, Type 2 Diabetes, High Blood Pressure, Mood Disorders and ROME III criteria (IBS)) to those found in a healthy cohort. In addition, these charts feature patient results marked as high (H) or low (L) compared to the reference range for each commensal bacteria or biomarker.
What Can Clinicians and Patients Expect from GI Effects Comprehensive Profile Stool Testing?
Functional testing can help uncover the root cause of many chronic conditions that often frustrate both physician and patient. The scope of the premier biomarkers on the GI Effects Stool Profile provides comprehensive information to the clinician for the development of strategic interventions. As identified functional imbalances and inadequacies become more normalized through targeted dietary, lifestyle, and supplementation therapeutics, intractable symptoms often improve for many patients.
Each biomarker is associated with specific pertinent therapies, but general therapeutic considerations include:
- Discerning general evidence of bowel inflammation and providing intestinal mucosal and anti-inflammatory support
- Addressing any identified infection with appropriate pharmacological and botanical treatments
- Supporting commensal bacteria with pre/probiotic supplements and dietary changes
A structured diagnostic panel, like the GI Effects Comprehensive Stool Profile, is easier for patients and clinicians to implement in practice compared to the stressors associated with serial testing. The GI Effects Comprehensive Stool Profile also helps to provide enhanced clinical accuracy in determining which patients may need additional, more invasive testing.