SALIVA-BASED SCREENING PLATFORM

Decoding your mouth.

Real-time biological signals from a single saliva sample

Oral Genome® is a validated point-of-care screening platform designed to detect active biological signals associated with oral and systemic health — delivering real-time insights to support preventive and longitudinal care models.

For wellness and screening purposes only. Not intended to diagnose, treat, cure, or prevent any disease.

Oral Genome saliva-based screening kit: device, collection supplies, and instruction card

Validation Overview

Validated across four critical domains

Oral Genome has undergone rigorous validation spanning laboratory performance, manufacturing consistency, clinical sample evaluation, and environmental stability — demonstrating reliable results across real-world conditions.

R² >0.95

Analytical performance

Calibration curves met predefined acceptance criteria with low variability across replicates and stable signal detection.

10K+

Manufacturing validation

Tens of thousands of test strips evaluated across production runs from start to end of batch — all met quality specifications.

Real-world

Clinical sample evaluation

Evaluated using real human saliva samples with consistent signal detection and reproducible results across replicates.

Stable

Environmental & stability

Performance maintained under elevated temperature stress and extended storage. Validated across clinical, home, and community settings.

Platform Technology

How Oral Genome works

A multi-analyte platform combining lateral flow immunoassay and colorimetric pad chemistry — detecting host-response markers, pathogens, and oral environment signals from a single saliva sample at the point of care.

  • Dual-technology detection

    Lateral flow captures MMP-8 and P. gingivalis via antibody-based gold nanoparticle conjugates. Colorimetric pads simultaneously measure pH, buffering capacity, nitric oxide, and proteins.

  • Active signal detection, not just presence

    Unlike DNA-based sequencing, Oral Genome detects active protein expression and live bacterial loads — distinguishing an active biological event from historical genetic residue.

  • Point-of-care design

    Results generated chairside in real time — no lab send-out, no days-long turnaround. Designed for integration into routine dental workflows without specialized equipment.

  • AI-assisted digital interpretation

    Computer vision reads both lateral flow bands and colorimetric pad intensities in a single image — eliminating subjective visual reading and logging results automatically.

  • Continuous platform improvement

    Ongoing refinements across software, hardware, and manufacturing informed by real-world deployment data to improve performance and usability.

Science Behind The Test

How the test works

Oral Genome combines two proven test formats in one. Lateral flow immunoassay detects MMP-8 and P. gingivalis. A colorimetric dipstick strip — like a UTI test but for saliva — measures pH, buffering capacity, nitric oxide, and proteins. Saliva is dropped directly onto each test zone; the Oral Genome app reads both simultaneously.

Step 1: saliva is dropped onto both test zones

Step 1 — Saliva dropped directly onto both test zones

Using a dropper, saliva is applied directly onto the sample pad of the lateral flow cassette (left) and onto the colorimetric pads of the dipstick strip (right). No dipping, no cup. The dropper delivers a controlled volume to each test zone.

Lateral flow result interpretation

Positive result

Two lines - Positive

Both T and C lines appear. Target analyte captured.

Negative result

One line - Negative

Only C line appears. No analyte captured at T.

Invalid result

No C line - Invalid

Control line absent. Flow or reagents failed.

Competitive context

How Oral Genome compares

Saliva testing has evolved - but most approaches still rely on either DNA sequencing or quantitative PCR (qPCR) methods that weren't designed for point-of-care use. Oral Genome takes a fundamentally different approach.

DNA sequencing platforms

Microbiome-based mail-in testing

  • Days-to-weeks turnaround - no real-time clinical decision support

  • Detects DNA presence only - not active biological activity or live load

  • Requires laboratory infrastructure - not chairside

  • Cannot detect host inflammatory response

  • Results require specialist interpretation

Oral Genome

Lateral flow + colorimetric point-of-care platform

  • Real-time results at chairside - no lab send-out required

  • Detects active protein signals and live bacterial activity

  • 6 markers: MMP-8, P. gingivalis, pH, buffering, nitric oxide, proteins

  • AI + computer vision - standardized across operators

  • Designed for longitudinal preventive care monitoring

qPCR-based tests

Quantitative PCR laboratory methods

  • Requires thermocycler equipment and trained personnel

  • Amplifies DNA only - cannot detect host inflammatory markers

  • Higher cost and longer processing limits routine screening

  • Prone to contamination artifacts - strict QC required

  • Not designed for high-volume preventive screening workflows

Analytical specificity

Selective detection of intended targets

Oral Genome assays demonstrated no measurable cross-reactivity with common oral bacteria, real-world substances, or complex salivary proteins under tested conditions.

MMP-8 assay

Host-response marker

Evaluated against five oral bacterial species at 10⁶ CFU/mL:

S. mutansS. oralisF. nucleatumL. rhamnosusP. gingivalis

No cross-reactivity observed

P. gingivalis assay

Pathogen-specific marker

Evaluated following sample preparation optimization:

S. mutansS. oralisF. nucleatumL. rhamnosus

Selective detection confirmed

Interference testing

Real-world conditions - no interference observed

Tested in the presence of common oral substances and salivary proteins in both positive and negative samples:

Alcohol

Alcohol

No effect

Toothpaste

Toothpaste

No effect

Mouthwash

Mouthwash

No effect

OTC meds

OTC meds

No effect

IgA

IgA

No effect

Transferrin

Transferrin

No effect

Amylase

Amylase

No effect