What Gemelli Biotech does

Gemelli Biotech is a US-based precision diagnostics company that develops and commercializes at-home clinical tests for gastrointestinal diseases, primarily SIBO (Small Intestinal Bacterial Overgrowth), IMO (Intestinal Methanogen Overgrowth), ISO (Intestinal Sulfide Overproduction), and post-infectious IBS (PI-IBS). The company was founded in 2018 and is headquartered in Raleigh, North Carolina, with research and product co-development rooted in Cedars-Sinai's Medically Associated Science and Technology (MAST) Program, where the underlying biomarker science originated.

The company's product line consists of two core tests. Trio-Smart is a Laboratory Developed Test (LDT) conducted at a CLIA-certified lab that uses an at-home breath collection device to measure three fermented gases (hydrogen, methane, and hydrogen sulfide), distinguishing it from conventional two-gas breath tests with a stated 20x sensitivity advantage. IBS-Smart is an at-home capillary blood test (collected via a Tasso device) that measures anti-CdtB and anti-vinculin antibodies with a stated positive predictive value of 96-100% for diagnosing post-infectious IBS. A Trio-Smart Malabsorption variant extends the breath test to lactose, fructose, and sucrose intolerance. Both core products require a valid prescription from a licensed healthcare provider.

Gemelli generates revenue through one-time sales of at-home collection kits ordered via direct-to-consumer e-commerce websites, through healthcare provider ordering channels, and via third-party telehealth and fulfillment partners who facilitate prescription processing. The company claims a cumulative user base of over 100,000 patients and physicians, and counts Johns Hopkins, Stanford, UCLA, Yale, and Sutter Health among named adopters. The company has raised approximately $28.35M in cumulative funding across seed, early, and Series A rounds (Series A of $19M led by Blue Ox Healthcare Partners in June 2022), is privately held, and operates with 11-50 employees.

Name

Gemelli Biotech

Legal name

Gemelli Biotech Corp.

Website

https://gemellibiotech.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Gemelli Biotech is a US-based precision diagnostics company that develops and sells at-home clinical tests for gastrointestinal conditions including SIBO, IMO, ISO, and post-infectious IBS, serving patients with chronic gut symptoms and prescribing gastroenterologists and GI clinics.

Ownership category

akta.pro rank

Headquarters

HQ city

Raleigh

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Services

Cost components

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

Revenue model

1. Diagnostic Test Sales: One-time sale of at-home collection kits (breath tests and blood tests) ordered by patients with a valid prescription from a licensed healthcare provider. Tests are processed at CLIA-certified labs.
2. Provider/Prescriber Orders: Healthcare providers order collection kits to ship to their offices or directly to patients. Fulfillment handled through independent third-party medical providers and fulfillment partners.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Gemelli Biotech develops and sells at-home precision diagnostic test kits for gastrointestinal diseases, primarily the Trio-Smart 3-gas breath test for SIBO, IMO, and ISO and the IBS-Smart blood test for post-infectious IBS. Tests are self-collected at home, shipped to CLIA-certified laboratories, and produce results delivered electronically within 2-5 business days.

Product overview

Gemelli Biotech offers two core at-home GI diagnostic test products: Trio-Smart, a 3-gas breath test that measures hydrogen, methane, and hydrogen sulfide to diagnose SIBO, IMO, and ISO; and IBS-Smart, a blood test that detects anti-CdtB and anti-vinculin antibodies to diagnose post-infectious IBS. Trio-Smart also has a malabsorption variant for testing lactose, fructose, and sucrose intolerance. Both tests are ordered online, collected at home, and shipped to CLIA-certified labs for processing with results delivered electronically.

Differentiator

Problem solved

Functional benefit

Brands

• Trio-Smart: A 3-gas breath test for identifying SIBO, IMO, and ISO by measuring hydrogen, methane, and hydrogen sulfide.
• IBS-Smart

Products and services

• Trio-Smart At-home 3-gas breath test that measures hydrogen, methane, and hydrogen sulfide to identify SIBO (Small Intestinal Bacterial Overgrowth), IMO (Intestinal Methanogen Overgrowth), and ISO (Intestinal Sulfide Overproduction). Breath samples are self-collected at home and shipped to a CLIA-certified lab for analysis, with results delivered within 2-5 business days. Reported to be 20x more sensitive than conventional breath tests and used by over 100,000 patients and physicians.
• Trio-Smart Malabsorption Test A variant of the Trio-Smart breath test that screens for carbohydrate malabsorption, including lactose, fructose, and sucrose intolerance, using the same at-home breath collection methodology.
• IBS-Smart At-home capillary blood test that measures anti-CdtB and anti-vinculin antibodies to diagnose Post-Infectious IBS (PI-IBS). Uses the Tasso device for virtually painless at-home capillary blood collection, with a reported positive predictive value of 96% to 100% and results delivered within 2-5 business days.

Quantifiable outcome

• 20x more sensitive than conventional breath tests
• +3 more outcomes

Named customers5 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature3 records

Partnerships

Two partnerships are on record, tiered core and supporting.

• Cedars-SinaicoreStrategic or Co-development Partner · 22 June 2022Founding investor and strategic partner through the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai. Co-developed IBS-Smart and supports ongoing innovation. Provides early access to microbiome research discoveries.
• TassosupportingTechnology or IntegrationProvides the Tasso device used in the IBS-Smart kit for at-home capillary blood collection. Enables convenient, virtually painless blood sampling without needles or phlebotomy visits.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Commonwealth Diagnostics International: Direct peer offering SIBO and IMO breath testing diagnostic services to clinicians and patients. Highly comparable in product category (GI breath testing) and clinical customer base, though historically focused on 2-gas rather than 3-gas measurement.
• Genova Diagnostics: Specialty clinical laboratory offering GI diagnostics including SIBO breath tests and stool-based microbiome assessments. Directly comparable as a specialty diagnostics lab serving functional/holistic GI clinicians with similar test menu and patient population.
• Doctor's Data: Specialty reference lab providing SIBO breath testing and comprehensive stool analysis for clinicians treating functional GI disorders. Closely comparable reference lab model and prescriber channel.
• Aerodiagnostics: Breath testing laboratory focused on SIBO, IMO, and lactose intolerance. Direct peer in the same GI breath testing category with overlapping patient and prescriber audiences.

Broad incumbents

• Prometheus Laboratories: Established specialty GI diagnostics company (now part of Nestlé Health Science) offering IBD, IBS, and celiac serology/antibody testing. Comparable specialty GI diagnostics focus with broader portfolio and institutional presence.
• BioFire Diagnostics: Subsidiary of bioMérieux offering multiplex molecular GI pathogen panels (FilmArray). Comparable GI diagnostics focus at higher-incidence infection end of spectrum, well-capitalized incumbent.
• Cleveland HeartLab (now part of Quest Diagnostics): Specialty diagnostic services now under Quest, historically built a specialty-test channel to clinicians that mirrors Gemelli's prescriber-driven model. Relevant comparable for scaling a specialty assay through clinician adoption before eventual acquisition or platform integration.

Emerging players

• Viome Life Sciences: D2C microbiome and gut health testing company using stool-based RNA analysis for personalized recommendations. Comparable as a consumer-facing gut diagnostics brand, though uses different underlying technology (metatranscriptomics).
• Thorne (formerly Onegevity): Health and wellness testing brand offering gut microbiome and wellness panels to consumers and practitioners. Comparable D2C gut diagnostics positioning with practitioner channel overlap.

Others

• Tasso: Provider of the at-home capillary blood collection device used in Gemelli's IBS-Smart kit. Adjacent technology partner rather than competitor; relevant comparably for at-home diagnostic device economics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key highlights7 records

Customer concentration

• Xtwitter.com/GemelliBiotech
• YouTubeyoutube.com/@GemelliBiotech
• Facebookfacebook.com/GemelliBiotech
• LinkedInlinkedin.com/company/gemellibiotech
• Instagraminstagram.com/gemellibiotech

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds4 records

Investors4 records

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

M&A

Investments

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

Frequently asked questions about Gemelli Biotech