Genomadix

What Genomadix does

Genomadix is a Canadian molecular diagnostics company headquartered in Kanata, Ontario, founded in 2021 when Casa-Dea Finance Limited acquired the assets of Spartan Bioscience Inc. The company develops and commercializes the Genomadix Cube, a portable point-of-care real-time qPCR instrument that performs sample-to-result genetic testing in approximately one hour from a buccal swab, with no pipetting, DNA extraction, calibration, or maintenance required. Its core commercial product is the FDA 510(k)-cleared, Health Canada-licensed, and CE-marked CYP2C19 Test, which identifies *2, *3, and *17 alleles with 99.1% validated accuracy to guide antiplatelet therapy decisions (clopidogrel, ticagrelor, prasugrel) for stroke, TIA, and acute coronary syndrome patients. Approximately 30% of North American and European patients carry CYP2C19 Loss of Function variants that impair clopidogrel metabolism, creating a recurring consumables market of roughly 1.2 million under-served patients annually. The company also offers an APOE genotyping test (Research Use Only, working toward IVD clearance) for Alzheimer's disease risk assessment and a CubeX Open Platform licensed to partners for non-clinical PCR applications.

The business model combines hardware sales of the Genomadix Cube instrument with recurring revenue from proprietary single-use test cartridges, reimbursed in the US under CPT Code 81225 (CYP2C19 gene analysis). Distribution is primarily direct enterprise sales targeting stroke and cardiology departments, genomics labs, and telestroke networks, anchored by adoption at Stanford Medical Center and Mayo Clinic (which also holds a know-how license and stock purchase agreement for telestroke expansion). A secondary OEM/licensing revenue stream is generated through CubeX Open Platform agreements, notably with LuminUltra for applied markets (water, energy, food and beverage) following the 2024 divestiture of Genomadix's Legionella business to the same partner. The company is led by CEO Hollie Huff, Ph.D. (appointed October 2025), with a 1-10 person headcount and is privately held.

Name

Genomadix

Legal name

Genomadix Inc.

Website

https://genomadix.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Genomadix develops and commercializes the Genomadix Cube, a portable point-of-care real-time qPCR molecular diagnostics platform delivering sample-to-result CYP2C19 and APOE genotyping in approximately one hour from a buccal swab, serving hospital systems, telestroke networks, and clinical researchers.

Ownership category

akta.pro rank

Product category

Point-of-Care Molecular Diagnostics

NAICS

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

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Pharmacogenomics (PGx) Decision Support (HLAAANAB)

akta.pro secondary industries

Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD)

Keywords

• Point-of-care diagnostics
• Molecular diagnostic testing
• Pharmacogenomic genotyping
• PCR diagnostic platforms
• Precision medicine devices

Headquarters

HQ city

Kanata

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Hardware and Consumables Sales: Sale of Genomadix Cube instruments and proprietary test cartridges. The system uses single-use test cartridges for each CYP2C19 test, creating recurring consumable revenue. Reimbursement available from Medicare and most insurers using CPT Code 81225.
2. Technology Licensing (CubeX Platform): Licensing of CubeX Open Platform to third-party partners for development of PCR-based products in various markets. Revenue generated through platform licensing agreements such as the LuminUltra partnership for Legionella testing products.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Genomadix develops and commercializes the Genomadix Cube, a portable point-of-care real-time qPCR molecular diagnostic instrument that performs sample-to-result genetic tests from a buccal swab in approximately one hour. The company's core commercial test is the FDA 510(k)-cleared, Health Canada-licensed, and CE-IVD marked CYP2C19 genotyping test, which identifies the *2, *3, and *17 alleles to guide antiplatelet therapy decisions for stroke and acute coronary syndrome patients. The company also licenses its CubeX Open Platform technology to partners such as LuminUltra for development of PCR products in applied markets.

Product overview

Genomadix offers a portfolio of precision medicine molecular diagnostic products centered on the Genomadix Cube™ platform - a portable, sample-to-result PCR instrument that delivers genetic test results in approximately one hour. The core commercial product is the FDA-cleared, CE-marked, and Health Canada-licensed Genomadix Cube™ CYP2C19 Test for guiding antiplatelet therapy in stroke and cardiology patients. Additional offerings include the Genomadix Cube™ APOE Test (RUO) for Alzheimer's disease research, and the CubeX Open Platform for licensing to third-party assay developers. The company also previously offered Legionella environmental testing, which was divested to LuminUltra in 2024.

Differentiator

Problem solved

Functional benefit

Brands

• Genomadix Cube™: Molecular diagnostic instrument capable of performing tests for precision medicine genotyping on a sample-to-result platform. Portable size enables time-critical results in approximately one hour.
• Genomadix Cube™ CYP2C19 System
• Genomadix Cube™ APOE Test (RUO)
• CubeX Open Platform

Products and services

• Genomadix Cube CYP2C19 Test FDA-cleared, Health Canada-licensed, and CE-IVD marked rapid CYP2C19 genotyping test that delivers results in approximately one hour from a cheek swab with 99.1% accuracy. Used by clinicians to guide P2Y12 inhibitor (e.g., clopidogrel) therapy decisions for minor stroke, TIA, and acute coronary syndrome patients carrying CYP2C19 Loss of Function variants.
• Genomadix Cube APOE Test (RUO) Research Use Only (RUO) ApoE genotyping test that identifies the ε4 allele of the Apolipoprotein E gene, the strongest genetic risk factor for late-onset Alzheimer's Disease. Used by research institutions and healthcare providers conducting Alzheimer's research or evaluating patient suitability for anti-amyloid antibody therapies such as Leqembi and Kisunla.
• Genomadix Cube Platform Portable molecular diagnostic instrument using real-time qPCR technology on a sample-to-result platform. Performs precision medicine genotyping with single-use test cartridges, requires no pipetting, DNA extraction, calibration or maintenance, and generates results in approximately one hour.
• CubeX Open Platform Licensable open platform version of the Genomadix Cube technology made available to industry partners to develop qPCR products for diverse applied markets where PCR-grade accuracy, speed, portability, simplicity, and low cost are required. First licensed to LuminUltra.

Quantifiable outcome

• 21% reduction in secondary strokes with ticagrelor vs clopidogrel in CYP2C19 LOF carriers (CHANCE-2 trial)
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered core and major.

• Mayo CliniccoreStrategic or Co-development Partner · 15 November 2024Second collaboration with Mayo Clinic focused on precision medicine for telestroke services. Mayo Clinic grants Genomadix access to specialized telestroke expertise to expand CYP2C19 testing into sites where stroke care is delivered remotely.
• LuminUltramajorOEM/ Whitelabel/ Licensing Partner · 9 September 2024Licensed CubeX Open Platform technology to LuminUltra, a global leader in applied molecular diagnostics for water, energy, and food & beverage markets. LuminUltra will develop a menu of PCR products for applied markets based on the CubeX platform. Genomadix also divested its Legionella business to LuminUltra.
• Stanford Medical CentermajorTechnology or Integration · 29 July 2024Stanford Medical Center introduced Genomadix Cube and rapid FDA-cleared CYP2C19 assay to their genomics lab, representing a flagship customer deployment of the technology at a leading academic medical center.
• Mayo CliniccoreStrategic or Co-development Partner · 29 August 2022Know-how license agreement and stock purchase agreement with Mayo Clinic to advance point-of-care molecular analyzer technology. Mayo Clinic provides specialized knowledge and technical expertise in telestroke services. Collaboration enables Genomadix to expand FDA-cleared CYP2C19 testing into remote telestroke sites across the US.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Cepheid (Danaher): Cepheid's GeneXpert system is the leading point-of-care real-time PCR platform used widely in hospitals for infectious disease and pharmacogenomic testing. It is the most directly comparable platform to the Genomadix Cube in workflow, customer base, and target clinical applications.
• Roche Diagnostics (cobas Liat): Roche's cobas Liat is a compact, rapid PCR system used at the point of care for infectious disease and selected pharmacogenomic indications. It competes head-to-head with the Genomadix Cube for hospital placement decisions and shares the same sample-to-result value proposition.
• Abbott (ID NOW): Abbott's ID NOW platform is a widely deployed rapid point-of-care molecular diagnostic system. While focused on infectious disease, it competes for the same hospital placement slots, CLIA-waived workflow simplicity, and decentralized testing mindshare as the Genomadix Cube.

Broad incumbents

• BioFire Diagnostics (bioMérieux): bioMérieux's BioFire FilmArray is a syndromic molecular diagnostic platform deployed broadly across hospital labs. It is a broad incumbent in clinical molecular diagnostics with overlapping customers and a much larger test menu than Genomadix.
• QuidelOrtho: QuidelOrtho is a broad incumbent in clinical diagnostics with rapid antigen and molecular platforms used in hospital and point-of-care settings. It is relevant given the new Genomadix CEO's prior leadership there and its overlapping hospital customer base.
• Hologic (Panther / Novodiag): Hologic's Panther molecular system is widely used in hospital and reference-lab settings for women's health and infectious disease testing. It is a broad incumbent with overlapping molecular diagnostic customers and complementary menu-development capabilities.
• QIAGEN: QIAGEN provides sample-prep-to-result molecular diagnostic and PGx testing solutions, including companion diagnostic partnerships. It is a broad incumbent competing both in PGx decision support and in laboratory molecular workflows adjacent to the Genomadix Cube.

Emerging players

• Visby Medical: Visby Medical develops single-use, palm-sized PCR devices for point-of-care infectious disease testing. It is an emerging player with similar value propositions around portability and ease of use and competes for the same decentralized-testing customer conversations.
• T2 Biosystems: T2 Biosystems develops rapid molecular diagnostics for sepsis and other time-critical indications. It is comparable in stage and clinical-decision-support focus, although it uses T2 Magnetic Resonance rather than PCR, making it an emerging adjacency rather than direct platform competitor.
• Genedrive: Genedrive is a small, point-of-care molecular diagnostics company developing rapid PCR-based tests for clinical and applied markets. It is comparable to Genomadix in size, stage, and platform philosophy, making it a closely matched emerging player.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/GenomadixInc
• LinkedInlinkedin.com/company/genomadix-bio

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments

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

Frequently asked questions about Genomadix