Direct Diagnostics
Direct Diagnostics operates OralDNA Labs, a CLIA-certified clinical laboratory that provides salivary diagnostic tests — including periodontal, HPV, caries, Candida, and HSV panels — to dental providers in the United States on a per-test billing basis.
- Company typePrivate
- Founded2015
- HeadquartersSan Marcos, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Direct Diagnostics does
Direct Diagnostics operates OralDNA Labs, a CLIA-certified and CAP-accredited clinical laboratory marketed as a service of Access Genetics LLC, headquartered in Eden Prairie, Minnesota. The company provides salivary diagnostic testing services to dental and medical providers, with a primary customer base of general dentists, periodontists, and dental hygienists who order laboratory tests to support clinical decision-making in periodontal disease management, HPV-related oral cancer risk assessment, caries risk, and detection of Candida and HSV. All tests are run on a universal oral rinse collection kit — a 30-second swish-and-gargle sample collection protocol — analyzed via real-time quantitative PCR in the company's laboratory, with results returned to the ordering provider.
The product portfolio spans nine registered trademarks covering periodontal pathogens (MyPerioPath), combined periodontal-plus-genetic testing (Alert 2, which bundles MyPerioPath with MyPerioID IL-6), HPV oral cancer risk (OraRisk HPV), caries risk (OraRisk Caries), Candida detection (OraRisk Candida), herpes simplex virus detection (OraRisk HSV), and a comprehensive panel (Celsus One). The company has expanded technical capability through the acquisition of Sensible Diagnostics' patent-pending real-time qPCR platform, intended to enable point-of-care rapid PCR testing alongside its existing send-out laboratory model. No AI/ML capabilities are disclosed; the underlying technology is molecular diagnostics rather than computational.
Commercial activity is concentrated in the United States and executed through a sales-led, B2B model targeting dental practices. Providers order tests via the Access Genetics portal, and the company generates revenue on a per-test basis consistent with a clinical laboratory service model; pricing is not publicly disclosed. Distribution is augmented by a channel partnership with Pacific Dental Services (PDS), whose supported dental offices offer OralDNA testing, and by a Doctor Finder tool that funnels consumer interest toward participating providers. Marketing is built on clinical education assets — a weekly blog, monthly newsletter, case studies, protocol directory, and bibliography — plus active presence on LinkedIn, Facebook, Instagram, and YouTube.
Direct Diagnostics firmographics
Firmographics- Name
- Direct Diagnostics
- Legal name
- OralDNA Labs, A Service of Access Genetics LLC
- Website
- https://directdiagnostics.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Direct Diagnostics operates OralDNA Labs, a CLIA-certified clinical laboratory that provides salivary diagnostic tests — including periodontal, HPV, caries, Candida, and HSV panels — to dental providers in the United States on a per-test billing basis.
- Ownership category
- akta.pro rank
Direct Diagnostics industry classification
Industry- Product category
- Clinical Laboratory Services / Dental Diagnostics
- NAICS
- Medical Laboratories (621511)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Periodontal Diagnostics & Risk Assessment (Perio Charting/Microbial Testing) (HLABACAL)
- akta.pro secondary industries
- Oral Cancer Screening (HLABAHAF), Caries Risk Assessment & Preventive Planning (HLABAHAE)
Keywords
Where Direct Diagnostics is headquartered
LocationHeadquarters
- HQ city
- San Marcos
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Direct Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain
Revenue model
- Salivary Diagnostic Testing Services: OralDNA Labs generates revenue by providing salivary diagnostic laboratory testing services to dental and medical providers. Providers order tests (e.g., MyPerioPath, OraRisk HPV, Alert 2) and send patient samples to the lab for analysis. Results are returned to the ordering provider for clinical decision-making. Revenue is derived from per-test billing, consistent with a clinical laboratory service model.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Direct Diagnostics product offering
Product offeringCore offering
Direct Diagnostics operates OralDNA Labs, a CLIA-certified clinical laboratory providing salivary diagnostic testing services to dental and medical providers. The company offers a portfolio of molecular diagnostic tests—including MyPerioPath, Alert 2, OraRisk HPV, OraRisk Caries, OraRisk Candida, OraRisk HSV, MyPerioID IL-6, and Celsus One—performed on patient saliva samples collected via a universal oral rinse kit. The service enables objective, laboratory-confirmed diagnostic data to support clinical decision-making in dentistry, including periodontal disease management, oral cancer risk assessment, caries risk evaluation, and detection of fungal and viral oral infections.
Product overview
OralDNA Labs (Direct Diagnostics) offers a platform of salivary diagnostic tests for oral health assessment. The portfolio centers on a universal oral rinse collection kit used across all tests, with individual diagnostic products including MyPerioPath® for periodontal disease detection, OraRisk HPV® for oral cancer risk screening, and additional tests for caries risk, fungal infections (Candida), and viral infections (HSV). The Alert 2™ product combines MyPerioPath® with MyPerioID® IL-6 genetic testing for comprehensive personalized periodontal care. The company recently expanded capabilities through acquisition of Sensible Diagnostics' real-time quantitative PCR testing platform.
Differentiator
Problem solved
Functional benefit
Brands
- MyPerioPath®: Early warning and detection tool for periodontal disease
- Alert 2™
- OraRisk HPV®
- OraRisk Caries
- OraRisk Candida
- OraRisk HSV
- Celsus One
- MyPerioID IL-6
Products and services
- MyPerioPath® Salivary diagnostic test that analyzes oral bacteria to provide an early warning and detection tool for periodontal disease, helping dental healthcare providers understand the cause of gum disease and design targeted treatment plans.
- Alert 2™ Combined salivary testing platform that integrates MyPerioPath® and MyPerioID® IL-6 to deliver targeted treatment and personalized care for patients with periodontal disease.
- OraRisk HPV® Salivary diagnostic test that determines increased risk for HPV-related oral cancers, enabling early detection and clinical intervention.
- MyPerioID IL-6 Genetic marker salivary test that identifies interleukin-6 (IL-6) genetic variations associated with inflammatory response in periodontal disease, supporting personalized care.
- OraRisk Caries Salivary test that identifies bacteria associated with dental caries (cavities) risk to enable personalized preventive treatment.
- Celsus One Comprehensive salivary diagnostic panel providing multiple oral health biomarkers for complete patient assessment.
- OraRisk Candida Salivary test that detects Candida species associated with oral fungal infections and related conditions.
- OraRisk HSV Salivary diagnostic test for herpes simplex virus (HSV) detection to support diagnosis and management of oral herpes infections.
- Full Test Menu Aggregated catalog of OralDNA Labs' complete salivary diagnostic test offerings, providing dental and medical providers a single menu of all available molecular diagnostic tests performed on the universal oral rinse collection kit.
Quantifiable outcome
- Pacific Dental Services concluded that OralDNA testing improves oral health outcomes in PDS-supported offices.
Companies that use Direct Diagnostics
Customer profileNamed customers8 records
Segments1 record
Ideal customer profiles2 records
Direct Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Direct Diagnostics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Pacific Dental Services (PDS)corePacific Dental Services concluded that OralDNA testing improves oral health outcomes. PDS-supported dental offices now offer OralDNA salivary diagnostic testing to patients. This is a significant distribution channel partnership, with PDS operating a large network of supported dental practices.
- Sensible DiagnosticscoreOralDNA Labs acquired Sensible Diagnostics' patent-pending real-time quantitative PCR testing platform. This acquisition brings advanced molecular diagnostic technology in-house, expanding OralDNA's technical capabilities and enabling point-of-care rapid PCR testing in addition to its existing laboratory-based salivary diagnostics.
Scale indicators3 records
Recent moves4 records
Expansion highlights4 records
Direct Diagnostics competitors and assessment
Company assessmentDirect peers
- Dentognostics: Dentognostics develops and markets the PerioSafe/OralCheck chairside salivary aMMP-8 test for active periodontal disease — the most direct global competitor to OralDNA's MyPerioPath in objective salivary-based periodontal diagnostics.
- Bako Diagnostics: Bako Diagnostics is a specialty diagnostic laboratory serving dental and podiatric providers with anatomic pathology and microbiology testing, directly overlapping OralDNA's dental-focused diagnostic lab model and target customer base.
Broad incumbents
- Quest Diagnostics: Quest Diagnostics is a national clinical laboratory offering an extensive menu of diagnostic tests including HPV and infectious disease assays. It is comparable to OralDNA as a CLIA-certified reference lab, though it does not specialize in dental salivary diagnostics.
- Laboratory Corporation of America (Labcorp): Labcorp is one of the largest clinical reference laboratories in the U.S., providing diagnostic testing services across specialties. It competes broadly in the clinical lab space and could expand into dental/periodontal diagnostics over time.
- Sonic Healthcare: Sonic Healthcare is a global medical diagnostics provider operating reference laboratories across multiple specialties. It is comparable as a scaled, multi-specialty clinical lab that could plausibly enter the oral diagnostics category.
- Cepheid (Danaher): Cepheid, a Danaher subsidiary, is a leader in real-time PCR molecular diagnostic systems (GeneXpert). Comparable to OralDNA's newly acquired Sensible Diagnostics qPCR platform as an established point-of-care molecular diagnostics platform that could expand into oral pathogen testing.
- Hologic: Hologic is a major molecular diagnostics company (e.g., Panther system, HPV testing). Comparable to OralDNA for its molecular diagnostic capabilities and leadership in HPV testing — the same pathogen family addressed by OralDNA's OraRisk HPV test.
- Dentsply Sirona: Dentsply Sirona is a global dental equipment, technology, and consumables leader with deep relationships across dental practices. Comparable to OralDNA as a dominant player in the dental industry that could bundle or vertically integrate diagnostics into its practice workflow offerings.
Others
- Access Genetics (parent): Access Genetics LLC is the parent operating company of OralDNA Labs and operates the ordering portal (portal.access-genetics.com). While not a peer in the commercial sense, it provides the corporate and billing infrastructure behind OralDNA.
Emerging players
- Interleukin Genetics (now Genetic Technologies): Previously known for the PST genetic risk test for periodontal disease (a direct analog to OralDNA's MyPerioID IL-6). Comparable as a genetic-marker-based oral/periodontal risk assessment test, though now repositioned under Genetic Technologies with a broader focus.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Direct Diagnostics social profiles
Digital presenceDirect Diagnostics compliance and trust
Trust signalCompliance2 records
Direct Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Direct Diagnostics leadership team
Management profileNumber of profiles
Profiles1 record
Direct Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Direct Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Direct Diagnostics
What does Direct Diagnostics do?
Direct Diagnostics operates OralDNA Labs, a CLIA-certified clinical laboratory providing salivary diagnostic testing services to dental and medical providers. The company offers a portfolio of molecular diagnostic tests—including MyPerioPath, Alert 2, OraRisk HPV, OraRisk Caries, OraRisk Candida, OraRisk HSV, MyPerioID IL-6, and Celsus One—performed on patient saliva samples collected via a universal oral rinse kit. The service enables objective, laboratory-confirmed diagnostic data to support clinical decision-making in dentistry, including periodontal disease management, oral cancer risk assessment, caries risk evaluation, and detection of fungal and viral oral infections.
Is Direct Diagnostics a public or private company?
Direct Diagnostics is a private company. It is classified as management employee owned and is currently operating.
When was Direct Diagnostics founded?
Direct Diagnostics was founded in 2015. It employs 1 to 10 people.
Where is Direct Diagnostics based?
Direct Diagnostics is headquartered in San Marcos, United States, in the North America region.
How does Direct Diagnostics make money?
One revenue line is on record: salivary Diagnostic Testing Services.
Who are Direct Diagnostics's main competitors?
Direct peers on record are Dentognostics and Bako Diagnostics. Broad incumbents are Quest Diagnostics, Laboratory Corporation of America (Labcorp), Sonic Healthcare, Cepheid (Danaher), Hologic and Dentsply Sirona. Access Genetics (parent) is listed as an others. Interleukin Genetics (now Genetic Technologies) is listed as an emerging player.
Does Direct Diagnostics have an API?
No public API is recorded for Direct Diagnostics.
What industry is Direct Diagnostics in?
Direct Diagnostics's product category is Clinical Laboratory Services / Dental Diagnostics. Its primary akta.pro industry code is HLABACAL, Periodontal Diagnostics & Risk Assessment (Perio Charting/Microbial Testing), with a secondary code of HLABAHAF, Oral Cancer Screening. Its NAICS code is 621511 and its SIC code is 8071.