Genova Diagnostics

What Genova Diagnostics does

Genova Diagnostics is a privately held clinical laboratory founded in 1985 and headquartered in Asheville, North Carolina, that provides specialty diagnostic testing primarily to licensed healthcare providers (MDs, DOs, DCs, NDs, NPs) and, through its direct-to-consumer Genova Connect platform, to individual patients. The company operates across gut health, nutrition, hormonal health, immune function, and specialty testing categories, with a portfolio of 19+ branded products including GI Effects (multi-method stool profile), Microbiomix (metagenomic whole-genome sequencing via partner Microba), NutrEval (125+ biomarkers), Metabolomix+, SIBO breath testing, One Day Hormone Check, and the newly launched Alzheimer's Assessment (p-Tau217). Underlying testing combines PCR, culture, microscopy, MALDI-TOF MS, metagenomic sequencing, and immunoassay methodologies, analyzed against Genova's proprietary 28,000+ species reference database and interpreted using its inflammatory and methane dysbiosis scoring algorithms.

The business model is transaction-based: providers or patients pay per test through a combination of commercial insurance billing (Genova is in-network with CareFirst Blue Cross Blue Shield and Blue Shield of California, and participates in Medicare and Tricare), provider Net-30 billing, and direct patient cash pay with HSA/FSA acceptance and interest-free installment plans for tests over $150. The myGDX portal serves as the clinician-facing platform for ordering, EHR integration, and result delivery, while Genova Connect extends access to non-prescriber consumers. A mobile phlebotomy partnership with Getlabs adds at-home and office blood draw capability at a $90 per-draw fee. The company states 40 years of clinical use, analysis of more than 300 biomarkers across major functional systems, and international reach across the US, UK, and additional markets, with certain geographic restrictions (e.g., select products unavailable in New York; practitioner pay unavailable in NJ and RI).

Genova holds HIPAA and GDPR compliance frameworks, files claims across major payer categories (excluding Medicaid), and is a privately held corporate entity (Genova Diagnostics Inc., North Carolina) with no disclosed parent company, funding rounds, or institutional ownership. No public revenue, headcount, or financial performance figures are disclosed in available sources.

Name

Genova Diagnostics

Legal name

Genova Diagnostics Inc.

Website

https://gdx.net

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

251–500 employees

Short description

Genova Diagnostics is a privately held specialty clinical laboratory founded in 1985 that provides functional medicine diagnostic testing — including stool, nutritional, hormonal, and specialty biomarker panels — to licensed healthcare providers and direct-to-consumer patients across the US, UK, and international markets via its myGDX and Genova Connect platforms.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

akta.pro secondary industries

Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD), Genetic & Prenatal Testing Laboratories (HLAFAMAH)

Keywords

• Clinical laboratory diagnostics
• Functional medicine testing
• Gut microbiome testing
• Specialty diagnostic services
• Hormone testing services

Headquarters

HQ city

Asheville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Laboratory Diagnostic Testing Services: Core revenue from laboratory testing services for healthcare providers and patients. Tests are billed per test with pricing dependent on specific profiles, panels, and add-ons ordered. Revenue generated through direct patient pay, insurance billing, Medicare/Tricare, and provider billing (Net 30).
2. Insurance and Medicare Billing: Genova files claims to commercial insurance plans (including Medicare Advantage) and participates with Medicare and Tricare. Initial patient payments are collected at activation with additional billing after insurance processing.
3. Patient Direct Pay: Cash pay option for uninsured patients or those choosing to file claims themselves. Includes interest-free payment plan (up to 4 installments) for tests over $150. HSA and FSA funds accepted.
4. Provider/Clinician Billing: Healthcare providers can be billed at Net 30 terms or place credit card on file for automatic payment upon test completion or monthly account balance charging.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Genova Diagnostics is a clinical laboratory that performs advanced specialty diagnostic testing for personalized health, analyzing 300+ biomarkers across gut health, nutrition, hormonal health, immune function, and specialty domains. Tests are ordered primarily by licensed healthcare providers through the myGDX portal and are also accessible directly to consumers through Genova Connect, with specimens (stool, blood, urine, saliva, breath, buccal) processed at the company's Asheville, NC laboratory.

Product overview

Genova Diagnostics is a clinical laboratory offering advanced diagnostic testing for personalized health. The portfolio includes multiple testing categories: Gut Health (GI Effects®, SIBO, Microbiomix™), Nutrition (NutrEval®, Metabolomix+®, Methylation Panel, Organix, Fatty15), Hormonal Health (Adrenocortex Stress Profile, One Day Hormone Check™, Women's Health+, Endo+, Comprehensive Thyroid Assessment, Comprehensive Melatonin Profile), Immune Function (Alcat Test, Food Sensitivity+, Celiac Profile), and Specialty (Alzheimer's Assessment p-Tau217, Cardio Check, DetoxiGenomic Profile). The core platform is the myGDX provider portal for test ordering and results. Testing utilizes multiple specimen types including stool, breath, urine, blood, saliva, and buccal swabs. Many tests are available with add-on modules such as Microbiomix for enhanced microbiome analysis and IgG Food Antibodies for comprehensive immune assessment.

Differentiator

Problem solved

Functional benefit

Brands

• GI Effects: Comprehensive stool profile testing for gut health assessment including digestion, inflammation, and microbiome analysis
• NutrEval
• Metabolomix+
• SIBO
• Microbiomix
• Methylation Panel
• Adrenocortex Stress Profile
• One Day Hormone Check
• Women's Health+
• Alcat Test
• Genova Connect
• myGDX
• Endo+

Products and services

• GI Effects® Comprehensive Stool Profile Comprehensive stool profile for healthcare providers and patients assessing gut health through digestion, inflammation, and microbiome markers using multi-method testing combining PCR, culture, and microscopy to identify digestive function, intestinal inflammation, and commensal/pathogenic organisms.
• Microbiomix™ Metagenomic stool analysis using whole-genome shotgun sequencing to assess complete gut microbiome and functional potential for clinicians and patients; available as standalone profile or add-on to GI Effects Comprehensive.
• SIBO Breath Test Non-invasive hydrogen and methane breath test measuring gases following lactulose ingestion to evaluate small intestinal bacterial overgrowth and intestinal methanogen overgrowth; available in 2-hour and 3-hour formats for healthcare providers and patients.
• NutrEval® Comprehensive nutritional profile using blood and urine to evaluate 125+ biomarkers and assess functional need for 40 antioxidants, vitamins, minerals, essential fatty acids, amino acids, and digestive support; available in FMV and Plasma versions for clinicians and patients.
• Metabolomix+® Non-invasive at-home nutritional test using first morning void urine collection with optional bloodspot finger stick and buccal swab for clinicians and patients; analyzes organic acids, amino acids, fatty acids, and oxidative stress markers.
• Methylation Panel Combined phenotypic and genotypic assessment of the biochemical methylation pathway using plasma metabolites and buccal swab genetic SNPs (MTHFR, COMT, TNF-a, APOE) for detoxification, mood, cardiovascular health, and energy production insights.
• Adrenocortex Stress Profile Salivary hormone test assessing the HPA axis through four timed cortisol and DHEA samples across the day to evaluate diurnal cortisol rhythm and adrenal function for clinicians and patients.
• One Day Hormone Check™ 24-hour salivary hormone test evaluating unbound bioavailable levels of estradiol, estrone, estriol, progesterone, testosterone, cortisol, DHEA, and melatonin in women and men.
• Women's Health+ Integrated metabolic and endocrine profile combining hormone panels, organic acid nutritional markers, and optional genetic SNPs using saliva, urine, and buccal swab samples for women's health.
• Endo+ Comprehensive customizable hormonal assessment evaluating thyroid, adrenal, melatonin, and sex hormones along with estrogen metabolism using saliva, serum, or urine samples.
• Alzheimer's Assessment (p-Tau217) Single-draw blood assessment measuring plasma p-Tau217 for early detection of Alzheimer's-related pathology (amyloid plaques and tau tangles) to support clinical decision-making.
• Alcat Test Leukocyte reactivity test assessing immune response to foods, additives, chemicals, and other substances for personalized nutrition strategies; newly added to Genova's Immune Function testing menu in 2025.
• Cardio Check Cardiovascular health assessment panel offered under the Specialty testing category for clinicians and patients.
• DetoxiGenomic Profile Genomic assessment of detoxification pathways offered under the Specialty testing category for clinicians and patients.
• Food Sensitivity+ IgG and IgE antibody profile measuring immune responses to commonly consumed foods and environmental allergens, available as a standalone or add-on to GI Effects, Metabolomix+, and Organix.
• Celiac Profile Comprehensive testing for celiac disease markers offered under the Immune Function category for clinicians and patients.
• myGDX Provider Portal Web-based provider portal for licensed healthcare professionals to order Genova Diagnostic tests, view pricing, track order status, and access results reports, with cloud-based EHR integration for streamlined ordering and results transmission.
• Genova Connect (Direct-to-Consumer Storefront) Online direct-to-consumer storefront at connect.gdx.net for individuals to purchase select gut health, nutrition, and hormonal health tests without a physician order, with optional provider matching for result interpretation.

Quantifiable outcome

• Analysis of more than 300 clinically relevant biomarkers
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature7 records

Partnerships

One partnership is on record.

• MicrobacoreTechnology or IntegrationGenova collaborates with Microba, who provides world-leading technology in metagenomic analysis and interpretation for the Microbiomix stool analysis product. Microba's Analysis Platform enables detection of over 28,000 species through their unmatched reference database. This partnership enables Genova to offer the most comprehensive gut microbiome testing combining biomarker analysis with genotypic data.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Doctor's Data: Doctor's Data is a specialty clinical laboratory offering stool-based GI testing, toxic element analysis, and other functional medicine diagnostics. It is one of the closest direct competitors to Genova in the functional/integrative medicine lab space, overlapping on microbiome and nutritional assessment offerings.
• Mosaic Diagnostics (formerly Great Plains Laboratory): Mosaic Diagnostics is a specialty lab focused on comprehensive stool parasitology, organic acids, and environmental toxin testing serving integrative and functional medicine practitioners. Direct overlap with Genova in gut health, nutrition, and specialty biomarker panels and target clinician base.
• ZRT Laboratory: ZRT Laboratory specializes in hormone and wellness testing using dried blood spot, saliva, and serum, sold primarily through healthcare providers. Strong overlap with Genova's hormonal health portfolio (Adrenocortex Stress Profile, One Day Hormone Check, Women's Health+).
• Vibrant Wellness (Vibrant America): Vibrant offers advanced specialty lab testing including food sensitivity, hormones, and gut health panels via provider channels and direct-to-consumer options. Competes head-to-head with Genova in functional medicine and DTC lab testing with strong digital/marketing capabilities.
• SpectraCell Laboratories: SpectraCell is a clinical laboratory specializing in micronutrient testing, cardiovascular risk panels, and immune-related diagnostics marketed to integrative and preventive medicine practitioners. Overlaps with Genova's NutrEval/Metabolomix nutritional assessment category.
• Boston Heart Diagnostics: Boston Heart Diagnostics is a specialty lab focused on advanced cardiovascular disease diagnostics sold through healthcare providers. Overlaps with Genova's specialty testing category (Cardio Check) and provider-led specialty lab model.

Broad incumbents

• Quest Diagnostics (Specialty): Quest Diagnostics is a large national reference laboratory offering routine and specialty diagnostics across endocrinology, gastroenterology, and genetics. As a broad incumbent, Quest could expand into functional-medicine-adjacent specialty testing and compete on insurance coverage, logistics, and brand.
• Labcorp (Specialty/Wellness): Labcorp is a national reference lab with a growing portfolio in women's health, hormone, and specialty testing. As a broad incumbent with extensive payer contracts and phlebotomy infrastructure, Labcorp represents the scale-tier threat to Genova's niche functional diagnostics.

Others

• Microba: Microba is Genova's metagenomics technology partner whose Analysis Platform underlies the Microbiomix product. They are adjacent (enabling partner) rather than a direct competitor today, but they are a credible emerging player in gut microbiome analysis that could enter clinical lab services.

Emerging players

• Access Medical Labs: Access Medical Labs provides specialty diagnostics including hormones, infectious disease, and wellness panels with nationwide servicing. Overlaps with Genova's specialty/hormonal testing menu and competes for provider relationships in the DTC-adjacent segment.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/genova_gdx
• Facebookfacebook.com/genova.diagnostics
• LinkedInlinkedin.com/company/genova-diagnostics-inc-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Genova Diagnostics