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Genova Diagnostics

Genova Diagnostics

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Genova Diagnostics
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About the Lab

Genova Diagnostics offers a wide array of tests, and their most popular tests are their GI-Effects stool test, their NutrEval nutritional assessment test and SIBO breath tests.

Many providers turn to Genova tests for treating chronic GI issues, nutritional deficiencies, mood disorders, fatigue, chronic pain & inflammation, weight issues, cardiovascular concerns, and general health optimization.

Genova doesn't subscribe to a 'one size fits all’ approach when it comes to utilizing technology. They are committed to using the most clinically relevant technology to provide actionable results that aid patient treatment.

About Genova Diagnostics

History and Mission

Headquartered in Asheville, NC. Genova Diagnostics was established in 1986 as Great Smokies Diagnostic Laboratory.

Genova's mission statement is "to be the best provider of comprehensive and innovative clinical laboratory services for the prevention, diagnosis, and treatment of complex chronic disease." 

They provide testing services to all 50 states and globally.

The Genova Diagnostics Leadership Team combines decades of experience in various areas of the healthcare industry, many of whom have dedicated their entire careers to integrative and functional medicine.

From its inception, Genova Diagnostics has been driven by a mission to enhance the detection and management of gastrointestinal disorders through innovative diagnostic solutions. 

Innovation and Technology

Genova Diagnostics maintains a commitment to using the most clinically relevant technology to promote patient care through accurate diagnosis.

The array of technologies used includes but is not limited to 16S rRNA PCR, MALDI-TOF, ELISA, and Next-Generation DNA sequencing.  Each technology is chosen based on its ability to provide clear, actionable results that can guide patient treatment more effectively.

Genova Diagnostics's Testing Standards

Quality Control and Assurance

Genova Diagnostics adheres to industry standards to maintain the highest quality of testing.  They participate in external proficiency testing programs such as CAP, WSLH, and QMEQAS to ensure the accuracy of their laboratory assays. 

They also perform internal evaluations regularly, including inter-assay and intra-assay precision, analytical sensitivity, and interference studies, to uphold laboratory quality standards. All of their results are subject to stringent quality controls.

Their laboratory is fully licensed by CLIA, the federal agency overseeing laboratory operations, and holds additional licenses as required by individual states. 

Certifications and Licenses

Genova Diagnostics is licensed under the Clinical Laboratory Improvement Amendments (CLIA) and adheres to additional state-specific licensing requirements, demonstrating their commitment to maintaining the highest standards of laboratory practice. 

They are individually licensed in California, Maryland, New York, Pennsylvania, and Rhode Island.  

Technological Advancements

Genova Diagnostics is committed to incorporating the most advanced technologies available, including 16S rRNA PCR, MALDI-TOF, ELISA, and Next-Generation DNA sequencing. 

Popular Tests Offered by Genova Diagnostics

Genova Diagnostics is distinguished for its advanced diagnostic tools that cater specifically to gastrointestinal health, offering a range of tests that are essential for diagnosing and managing various digestive disorders. 

SIBO Assessments

The SIBO (Small Intestinal Bacterial Overgrowth) assessments are crucial for patients experiencing symptoms related to bacterial overgrowth in the small intestine. 

Genova Diagnostics offers both a 2-hour and a 3-hour test, the latter being recommended for patients with slower gastrointestinal transit times or constipation. 

GI Effects® Comprehensive Profiles

The GI Effects® Comprehensive Profile is another flagship offering from Genova Diagnostics. 

Available in both 1-day and 3-day versions, these advanced stool tests provide a thorough evaluation of digestive function, intestinal inflammation, and the intestinal microbiome. 

By assessing these critical areas, the tests assist healthcare providers in managing and optimizing gastrointestinal health, making it a valuable tool for patients suffering from a variety of GI-related issues.

NutrEval® Plasma and FMV

NutrEval® Plasma and NutrEval® FMV are comprehensive testing solutions designed to evaluate nutritional deficiencies and imbalances. 

These tests analyze a wide range of biomarkers including antioxidants, vitamins, minerals, and fatty acids in plasma, serum, urine, and whole blood. 

They identify specific nutritional needs of patients, and aid in the management of conditions related to nutrient deficiencies such as fatigue, mood disorders, and chronic inflammation.

Metabolomix+ and Its Add-Ons

Metabolomix+ combines the evaluation of key nutritional biomarkers such as organic acids, amino acids, and oxidative stress markers. 

This test, crucial for understanding a patient's metabolic makeup, can be enhanced with specific add-ons like the Toxic Element Clearance and the Bloodspot Essential & Metabolic Fatty Acids, to provide a more detailed assessment of a patient’s nutritional status and potential toxic exposures.

Complete List of Test Offerings

Digestive and Nutritional Profiles

GI Effects Fundamentals Profile (stool)

GI Effects Comprehensive Profile (stool)

Microbiomix

GI Effects Comprehensive Profile with Microbiomix (stool) 

GI Effects Microbial Ecology Profile (stool)

Gut Pathogen Profile (stool) 

SIBO Breath Test

Intestinal Permeability Assessment (urine) 

Celiac Profile

NutrEval

ION Profile (blood, urine)

Essential and Metabolic Fatty Acids

Amino Acids Analysis

Microbiology Analysis

Yeast Culture with KOH Prep

Immunology Panels

Full Immunology Panel (serum)

IgE Food Antibodies (serum) 

IgE Inhalants (serum)

IgE Molds (serum)

IgG Food Antibodies 

IgG Vegetarian (serum)

Metabolic and Detoxification Profiles

CardioCheck

Comprehensive Urine Elements Profile

Detoxigenomic Profile (swab) (swab)

Elemental Analysis (blood)

Glutathione (blood)

Metabolomix+

Methylation Panel (blood)

Organix

Oxidative Stress 2.0 Urine

Toxic Element Clearance Profile

Hormone Profiles

Adrenocortex Stress Profile (saliva)

Adrenocortex Stress Profile with Cortisol Awakening Response (saliva)

Comprehensive Melatonin Profile (saliva) 

Comprehensive Thyroid Assessment (serum)

Endo+

Essential Estrogens (urine)

Estrogen Metabolism Assessment (urine)

Hormonal Health (serum) 

Male Hormones Plus (saliva)

Menopause (saliva)

Menopause Check Plus (saliva)

Menopause Plus (saliva)

Menopause Plus + CAR (saliva)

One Day Hormone Check (saliva)

Salivary Cortisol

Rhythm (saliva)

Rhythm Plus (saliva)

Rhythm Plus + CAR (saliva)

Genetic Testing

SNP Add On: MTHFR C677T

Initial SNP: MTHFR Combined

Initial SNP: MTHFR C677T

Initial SNP: APO E (C112R + R158C)

Add On Tests: GI Effects

Campylobacter (stool) 

C. difficile EIA (stool)

E. coli EIA (stool)

Fecal Lactoferrin (stool)

Fecal sIgA (stool)

H. Pylori (stool)

KOH Prep for Yeast (stool) 

Macroscopic Examination for Worms (stool)

Parasitology Module (stool)

Yeast Culture (stool)

Zonulin (stool)

Add On Tests: NutrEval

Genomic SNP: APOE (swab) 

Genomic SNP: COMT (swab)

Genomic SNP: MTHFR Combined (swab)

Genomic SNP: TNF-alpha (swab)

Vitamin D (serum)

Add On Tests: Metabolomix+

Genomic SNP: APOE (swab) 

Genomic SNP: COMT (swab)

Genomic SNP: MTHFR (swab) 

Genomic SNP: TNF-alpha (swab) 

Bloodspot Essential & Metabolic Fatty Acids

Comprehensive Urine Element Profile

Toxic Element Clearance

Add On Tests: Methylation Panel

Methylation Genomics (swab)

Add On Tests: Hormone Panels

CAR (saliva)

Genomic SNP: CYP1B1 (swab) 

Genomic SNP: COMT (swab)

Genomic SNP: MTHFR Combined (swab) 

Add On Tests: Immunology Panels

Celiac Profile

IgE Foods (serum)

IgE Inhalants (serum)

IgE Molds (serum)

IgG Foods (serum) 

IgG Spices (serum)

IgG Vegetarian (serum) 

About the Lab

Genova Diagnostics offers a wide array of tests, though their most popular ones are their GI-Effects stool test, NutrEval nutritional test and SIBO breath tests.

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Quality Control Process

Shipping
5 - 10 days
FedEx
Shipment Tracking
Provides Tracking Number
Does Not Provide Tracking Number
Avg. Sample Processing
21 days
Consultation Availability
Certifications
CLIA Certified
CAP Accredited
ISO 15189
COLA Accredited
Order, track, and receive results from 30+ labs in one place.