DNA Genotek

What DNA Genotek does

DNA Genotek Inc., founded in 1998 and headquartered in Ottawa, Canada, is a wholly-owned subsidiary of OraSure Technologies (NASDAQ: OSUR) that develops and manufactures biological sample collection, stabilization, and preparation products. Its platform centers on NucleoPresicion Technology, a proprietary stabilization chemistry that preserves DNA and RNA at ambient temperatures for extended periods, eliminating cold-chain logistics and enabling at-home, mail-in, and field-based sample collection. The product portfolio spans saliva DNA collection (Oragene, ORAcollect), microbiome collection across gut, oral, vaginal, and skin sites (OMNIgene family), infectious-disease urine collection (Colli-Pee), blood-based proteomics (HEMAcollect PROTEIN BCT), animal genetics (PERFORMAgene, PERFORMAbiome), metabolomics (OMNImet GUT), and supporting DNA extraction reagents (prepIT, OMNIgene XTRACT).

The business generates revenue through one-time sales of consumable collection devices and reagents via a mix of direct online sales (store.orasure.com), an international distributor network covering 18+ countries, and a direct-to-donor order-fulfillment service that handles kitting, barcoding, warehousing, and API-integrated logistics. Customer segments are diversified across human genomics researchers, microbiome researchers, infectious-disease diagnostic labs, animal-genetics organizations, and proteomics researchers, with named users including academic institutions (RIKEN, University of Sao Paulo, Generation Scotland), transplant/stem-cell registries (Anthony Nolan), agricultural genetics players (Holstein Canada, La Ferme Gillette), and clinical labs (GeneCare). A core competitive position rests on the first and only FDA 510(k)-cleared saliva-based DNA collection devices (Oragene Dx, ORAcollect Dx) and the June 2026 FDA 510(k) clearance for Colli-Pee Dx, which is co-validated with Roche Diagnostics' cobas 5800, 6800, and 8800 molecular diagnostic systems for at-home STI testing.

Name

DNA Genotek

Legal name

DNA Genotek Inc.

Website

https://dnagenotek.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

DNA Genotek Inc., an Ottawa-based subsidiary of OraSure Technologies, manufactures FDA-cleared saliva, urine, microbiome, and proteomics sample collection devices using proprietary ambient-temperature NucleoPresicion stabilization chemistry, selling to research institutions, clinical diagnostic labs, and animal-genetics organizations in over 100 countries.

Ownership category

akta.pro rank

Product category

Biological Sample Collection Products

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Sample Collection, Stabilization & Pre-Analytics (biobanking, transport media, extraction kits) (HLAAALAM)

akta.pro secondary industries

Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), Genomic Testing & Genetic Evaluation Services (AFAEAJAC)

Keywords

• Biological sample collection
• DNA stabilization reagents
• Saliva collection devices
• Microbiome sampling kits
• Molecular diagnostics

Headquarters

HQ city

Ottawa

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Biological Sample Collection Products: Sale of collection devices and kits for DNA, RNA, and other biological sample types. Products include Oragene, ORAcollect, OMNIgene, Colli-Pee, HEMAcollect, and related reagents. Revenue is generated through direct sales and distributor channel sales globally.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels9 records

Core offering

DNA Genotek manufactures and sells biological sample collection, stabilization, and preparation products used in research, clinical diagnostics, and consumer genomics applications. The company's offerings include saliva, stool, urine, blood, and tissue collection devices that preserve DNA, RNA, and other analytes at ambient temperature, along with associated reagents, extraction kits, and ancillary kitting/fulfillment services for research-use and in vitro diagnostic applications.

Product overview

DNA Genotek provides a comprehensive portfolio of biological sample collection, stabilization, and preparation products for human genomics, microbiome, infectious disease, and animal genetics applications. The offering is organized as a platform of collection devices supported by companion reagents and extraction products, with FDA-cleared diagnostic devices (Oragene Dx, ORAcollect Dx, Colli-Pee Dx) forming the regulated product line alongside research-use-only products. Key product families include: Oragene/ORAcollect saliva DNA collection kits (with both FDA-cleared diagnostic and research variants); OMNIgene multi-omic collection devices for microbiome samples (gut, oral, vaginal, skin, saliva); HEMAcollect for proteomics; Colli-Pee for urine collection (infectious disease and STI testing); PERFORMAgene/PERFORMAbiome for animal genetics; and prepIT extraction reagents. Services include order fulfillment with direct-to-donor logistics and product customization/branding options. The company also offers anaerobe culture products and metabolomics collection through its OMNImet line.

Differentiator

Problem solved

Functional benefit

Brands

• Oragene: Saliva DNA collection devices for human genomics research and diagnostics
• OMNIgene
• ORAcollect
• Colli-Pee
• PERFORMAgene
• PERFORMAbiome
• HEMAcollect
• OMNImet
• prepIT
• go DNA

Products and services

• Oragene DNA (OG series) Saliva-based self-collection kit that stabilizes DNA at ambient temperature for genomic research and downstream genetic analysis. Used by research institutions, biobanks, and population-scale genomics projects.
• Oragene Dx (OGD series) FDA-cleared saliva DNA collection device for in vitro diagnostic use, enabling clinical-grade sample collection for molecular diagnostic workflows.
• ORAcollect DNA (OCR-100) Cheek swab-based DNA collection device for use cases where saliva collection is impractical, including pediatric and remote-sample applications, for research use.
• ORAcollect Dx (OCD-100) FDA-cleared cheek swab DNA collection device for in vitro diagnostic use, intended for clinical diagnostic sample collection.
• OMNIgene SALIVA DNA and RNA (OMR-610) All-in-one saliva collection and stabilization system that preserves both DNA and RNA at ambient temperature for downstream molecular analysis, including gene expression and microbiome studies.
• OMNIgene GUT (OM-200, OMR-200, OMD-200) Stool sample collection and stabilization devices (research-use and diagnostic variants) that preserve microbial DNA for gut microbiome research and clinical analysis.
• OMNIgene ORAL Oral sample collection device for stabilizing microbial DNA from the oral cavity for research into the oral microbiome.
• OMNIgene VAGINAL (OMR-130) Vaginal sample collection device for stabilizing microbial DNA from the vaginal microbiome, intended for women's health and microbiome research.
• OMNIgene SKIN (OMR-140) Skin sample collection device for stabilizing microbial DNA from skin surfaces, used in dermatological and skin microbiome research.
• OMNImet GUT (ME-200) Stool sample collection device optimized for stabilizing the metabolome in stool samples, used in metabolomics research.
• HEMAcollect PROTEIN BCT Blood collection tube designed to stabilize proteins in whole blood samples for downstream proteomics and protein-based biomarker analysis.
• Colli-Pee (FV-5000) First-void urine collection device that captures and stabilizes the initial urine stream for research applications, including STI and biomarker research.
• Colli-Pee Dx First-void urine collection device variant intended for in vitro diagnostic applications, including clinical STI and biomarker testing workflows.
• PERFORMAgene (PG-100) Stool sample collection device designed to support performance research and gut health analysis use cases.
• PERFORMAbiome GUT (PB-200) Stool sample collection device for gut microbiome applications, positioned for performance/sports and consumer health research use.
• prepIT L2P Laboratory reagent kit for manual DNA extraction and purification from samples collected using DNA Genotek collection devices.
• prepIT Q2A Laboratory reagent kit for DNA extraction and purification from samples collected using DNA Genotek collection devices.
• OMNIgene XTRACT Sample extraction product within the OMNIgene product family, supporting nucleic acid extraction workflows from collected samples.
• BIOME-Preserve Collection Kit Sample collection and preservation kit for microbiome applications, providing ambient-temperature stabilization of microbial DNA in collected specimens.
• Order Fulfillment Services Outsourced kitting, packaging, and direct-to-donor fulfillment services that allow customers to outsource end-to-end sample collection kit logistics.
• Product Customization and Branding Custom product design, packaging, and branding services that allow customers to differentiate their sample collection offerings under their own brand.

Quantifiable outcome

• DNA stable at ambient temperature for extended periods (up to one year for some products)
• +2 more outcomes

Named customers9 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and supporting.

• Roche DiagnosticscoreTechnology or Integration · 11 June 2026Roche Diagnostics is a key strategic partner for DNA Genotek's Colli-Pee Dx Urine Collection Kit. The FDA-cleared Colli-Pee Dx kit is designed for use specifically with Roche's molecular diagnostic systems (cobas 5800, 6800, and 8800) for STI testing including Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium detection.
• DiversigensupportingImplementation/ SI/ Consulting PartnerDiversigen is a certified CLIA laboratory partner that processes microbiome samples collected with DNA Genotek's collection devices. The partnership enables customers to direct their microbiome samples to Diversigen for professional sample processing, analysis, and bioinformatics services.
• International Distributors NetworkcoreChannel Partner/ Reseller/ DistributorDNA Genotek maintains a global network of international distributors covering over 18 countries/regions including Argentina (Tecnolab), Australia (GO LAB), Austria (Steinbrenner Laborsysteme), Brazil (Interprise), India (Imperial Life Sciences), Israel (Pronto), Italy (D.I.D. Diagnostic), Japan (Kyodo International), Malaysia (Nano Life Quest), Mexico (Genomica Medica), Portugal (Abyntek Biopharma), Saudi Arabia (Integrated Gulf Biosystems), Singapore (Sciencewerke), South Africa (Whitehead Scientific), South Korea (Daon Biosciences), and UAE.

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• COPAN Diagnostics: COPAN is a direct competitor in sample collection and transport media (eSwabs, UTM, fecal transport devices), serving clinical diagnostics, infectious disease, and microbiome customers with stabilized collection products analogous to DNA Genotek's lines.
• Streck: Streck develops stabilizing reagents and blood collection tubes (e.g., Cell-Free DNA BCT, RNA preservation) sold to clinical and research labs. Its ambient-temperature stabilization focus closely overlaps DNA Genotek's NucleoPresicion-based consumables.
• Sarstedt: Sarstedt is a large manufacturer of sample collection tubes, swabs, and urine containers used by research and diagnostic labs. Its products compete head-to-head with DNA Genotek's Colli-Pee and OMNIgene devices in sample collection workflows.
• Zymo Research: Zymo Research offers DNA/RNA collection and stabilization kits for microbiome and genomics applications, including fecal and saliva devices. Its product portfolio directly competes with DNA Genotek's OMNIgene and Oragene lines, especially in the microbiome research market.
• Puritan Medical Products: Puritan manufactures swabs, transport media, and sample collection devices used in diagnostic and research workflows. It competes with DNA Genotek's ORAcollect and OMNIgene oral collection products in clinical and at-home collection settings.

Broad incumbents

• Becton Dickinson (BD): BD is a broad incumbent in diagnostics and biosciences with sample collection devices (BD Vacutainer, flocked swabs) and molecular testing workflows. While not specialized in saliva-based DNA collection, it competes broadly in clinical sample collection and integrated diagnostic solutions.
• Qiagen: Qiagen provides sample collection, stabilization, and nucleic acid extraction kits (e.g., QIAamp, PAXgene) to research and clinical customers globally. Its comprehensive sample-to-result workflow portfolio overlaps significantly with DNA Genotek's collection and prepIT reagent offerings.
• Thermo Fisher Scientific: Thermo Fisher offers a broad portfolio of life science consumables, sample preparation reagents, and genomic analysis tools. Its Applied Biosystems and Invitrogen brands compete with DNA Genotek across research sample collection, stabilization, and extraction workflows.

Emerging players

• Isohelix: Isohelix specializes in buccal and saliva DNA collection devices for genetic testing and diagnostics. It is a niche, emerging competitor with overlapping technology in non-invasive DNA collection, similar to DNA Genotek's Oragene product line.
• Bio-Techne: Bio-Techne supplies proteomics and genomics research reagents, including protein stabilization and exosome/DNA sample preparation tools. Its proteomics and cell-free DNA preservation products overlap with DNA Genotek's HEMAcollect PROTEIN BCT.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/dnagenotek
• LinkedInlinkedin.com/company/dna-genotek

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

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 DNA Genotek