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Oral Genome is a rapid, general-wellness saliva test that measures selected biomarkers in the oral environment and provides wellness information. It is not intended to diagnose, treat, cure, prevent, screen for, or predict disease.

A smartphone-based application presents the biomarker results in a clear visual format that can support conversations about oral hygiene, lifestyle, prevention, and follow-up care. The application presents the results; the provider interprets them alongside the clinical picture.

See the seven salivary biomarkers

Neither. Oral Genome provides wellness and biomarker information that complements routine dental and medical care. It is not intended to diagnose, treat, cure, prevent, screen for, or predict disease.

Oral Genome is not intended to diagnose, screen for, predict, or determine risk for diabetes, heart disease, periodontal disease, or another systemic disease.

Results are interpreted alongside the patient's history, examination, imaging, periodontal findings and other appropriate tests. A result is one data point; it does not determine treatment.

General wellness is an established low-risk position, not a limitation: information, education, monitoring and healthy behavior, alongside professional evaluation.

Chairside, in dental and healthcare settings, as part of the clinical visit.

Oral Genome is a professional, chairside test designed to provide results during the same visit.

Oral Genome's current commercial focus is the United States. Availability in other countries depends on local regulatory and distribution requirements.

A saliva sample is applied to the test according to the collection instructions, and chemical and lateral-flow reactions create measurable color changes. The test is then photographed on a calibrated placement card, and the software analyzes the color information in the image and presents the biomarker results in the app for review.

1. 1

   Collect

   A saliva sample is applied to the test according to the collection instructions.

2. 2

   Develop

   Reactions develop measurable color changes over about ten minutes.

3. 3

   Capture

   The test is photographed on a calibrated placement card.

4. 4

   Present

   Software analyzes the image and presents the biomarker results in the app.

• About 2 minCollection
• About 10 minReaction develops
• ~10–15 minCollection to result

Collection itself takes about two minutes. The reaction develops for about ten minutes, and the overall collection-to-result process is approximately 10–15 minutes, depending on workflow.

No. Collection is a non-invasive saliva sample — no needle and no blood draw. Results are available during the same visit, so the conversation happens while the patient is still in the chair.

Follow the standard pre-test instruction: do not eat or drink anything except water for 30 minutes before saliva collection. Oral Genome does not require an additional waiting period solely because of antibiotic use or a recent dental cleaning.

Yes. Children and adolescents can complete the Oral Genome saliva test. Administration should follow the current Instructions for Use, the practice's clinical judgment and applicable consent requirements.

The patient's report is automatically emailed to the patient after the result is processed.

Yes. Salivary biomarkers can change with oral hygiene, diet, behavior, inflammation, treatment and other factors, so repeat testing can be useful for longitudinal monitoring. The retesting interval is set by the program and the clinician's judgment, rather than applied as a single interval to every patient.

A later measurement shows change; it does not prove that a treatment worked.

An invalid test is repeated or handled according to the current Instructions for Use and Provider Portal workflow.

Oral Genome tests have a two-year shelf life. Tests must be stored according to the current product labeling and Instructions for Use.

Oral Genome can be considered when objective salivary information may help a clinician educate, engage or longitudinally monitor a patient:

• New-patient evaluations
• Preventive and hygiene visits
• Periodontal maintenance
• Caries-risk discussions
• Patients whose oral findings or behaviors warrant closer monitoring

Clinical judgment remains primary. The test adds objective salivary information to that judgment rather than standing in for it.

Administration follows the product instructions, applicable state scope-of-practice rules, office policy and the supervising clinician's workflow. A trained team member may perform collection and image capture where permitted. Oral Genome does not state that a test can be administered without regard to license, training or state scope of practice.

Collection can occur early in the visit — during intake, or before other procedures. The test develops while the team continues the appointment, and results can be reviewed later in the same visit.

Because the test develops in parallel with the appointment, it is designed to add information to the visit rather than time to it.

Use the results as objective wellness information. Explain what was measured, whether the result sits within the program's reference category, what factors may influence it, and what clinical findings or behaviors should be considered alongside it.

Frame each biomarker as one input alongside the clinical findings, rather than as proof of disease. A result never determines what treatment is required — that is the clinician's decision, made with the exam in front of them.

Oral Genome is designed to make preventive and treatment conversations more visible, objective and understandable. When patients can see biomarker information alongside the clinical findings, it can help them better understand why the provider is making a recommendation and support stronger treatment-acceptance conversations. Practices should measure their own results; no specific acceptance rate or financial outcome is guaranteed.

Available onboarding and practice-support resources are defined by Oral Genome according to the current approved commercial and operating scope. Ordering, onboarding and implementation support is provided by Oral Genome.

Repeat testing can provide comparable salivary biomarker measurements across visits. Organization-level workflows, reporting, tracking, integrations, longitudinal programs, and outcome measurement require separate review with Oral Genome. Availability, scope, responsibilities, timing, and pricing are evaluated based on the organization's needs.

• pH

  Reflects the acidity or alkalinity of the oral environment.

• Buffering capacity

  Reflects saliva's ability to resist changes in acidity.

• P. gingivalis

  Porphyromonas gingivalis is an oral bacterium associated with periodontal ecology. Oral Genome measures a P. gingivalis-associated bacterial antigen using antibodies embedded within the lateral-flow strip as recognition tools. The result does not independently confirm active disease or diagnose periodontal disease.

• MMP-8

  A host-derived matrix metalloproteinase associated with inflammatory tissue remodeling.

• Nitric oxide

  A salivary biomarker influenced by oral and dietary biology.

• Glucose

  A salivary measurement that may be influenced by diet and metabolic factors.

• Salivary protein

  A broad measure of protein concentration in saliva.

Oral Genome measures MMP-8. Activated MMP-8, or aMMP-8, is a distinct term, and the two should not be used interchangeably.

The Oral Genome platform combines colorimetric chemistry and lateral-flow assay technology with smartphone image analysis.

The test is photographed in a standardized position on a calibrated card. The software analyzes the color information in the image and applies assay and batch calibration to present the reaction as biomarker results.

Lighting, camera characteristics, angle and color rendering can all affect image-based measurement. A standardized calibrated card provides a reference that helps the software normalize the image.

The application presents the biomarker results. The provider interprets the results alongside the clinical picture.

Not necessarily. Oral Genome is designed to provide biomarker-level information rather than only a binary visual line. The type of output depends on the biomarker and the assay chemistry.

Oral Genome's individual assays underwent internal analytical evaluation during product development. The evaluation addressed areas such as analytical sensitivity, selectivity, interference, precision, linearity, and stability.

These product-development evaluations are different from clinical sensitivity, clinical specificity, diagnostic accuracy, or independent peer-reviewed clinical validation. Analytical performance and clinical performance answer different questions, so Oral Genome does not use one accuracy percentage to describe the entire platform. Organizations requiring additional technical information may contact Oral Genome.

Contact Oral Genome

Oral Genome is positioned as a low-risk general-wellness product and is not marketed as an FDA-cleared diagnostic.

Coding and coverage depend on the service actually performed, the documentation, payer policy, state requirements, and the code set in effect on the date of service. Practices and their billing teams must verify the appropriate code, payer requirements, documentation requirements, and coverage for the service performed. Coverage and reimbursement are not guaranteed.

Eligibility can depend on the plan, the purpose of the purchase, and current IRS and plan rules. Patients should confirm eligibility with their HSA or FSA administrator before purchase.

Current pricing and purchasing options are available in the Oral Genome online store.

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