Unique Biosciences™ develops clinically focused, saliva-based molecular diagnostics to support precision oral health care. We combine laboratory best practices and multiplex qPCR technology to deliver actionable microbial profiles that help clinicians personalize prevention and treatment plans.
Frequently Asked Questions
UniquePerioSignature™ gives clinicians multiplex quantitative, signature pathogen-specific information for periodontal disease from a non-invasive saliva sample so they can identify microbial risk, guide targeted therapy, and monitor response — enabling evidence-based decisions beyond what visual exam alone provides.
It is a quantitative molecular assay (qPCR) that measures the abundance of a defined set of periodontal pathogens from a single saliva specimen and reports pathogen counts plus an interpretation to support clinical decision-making.
The panel targets the five key clinically important periodontal pathogens most strongly associated with periodontitis:
- Porphyromonas gingivalis (Pg)
- Aggregatibacter actinomycetemcomitans (Aa)
- Tannerella forsythia (Tf)
- Treponema denticola (Td)
- Prevotella intermedia (Pi)
Focusing on a validated set of high-risk periodontal pathogens gives clinically actionable data: these species have strong, reproducible associations with periodontal disease activity and treatment outcomes. A targeted 5-pathogen qPCR panel optimizes cost, turnaround time, and analytical performance while providing the most useful signals for clinical decisions.
Our assay is developed under clinical-laboratory quality standards and underwent analytical validation (limit of detection, linearity, reproducibility). Exact performance metrics are available on request and summarized in our validation report. (PDF of validation summary here.)
Sensitivity and specificity depend on the pathogen and the clinical cutoffs used. Our internal validation demonstrates clinically acceptable sensitivity/specificity for each target. (PDF of validation summary here.)
We use quantitative polymerase chain reaction (qPCR) with validated target-specific primers and probes. qPCR provides direct quantitation of target DNA, tight analytical performance, and rapid turnaround.
Main reasons:
- Quantitation: qPCR gives accurate, absolute or relative counts for each target species — essential for clinical thresholds.
- Speed & Cost: qPCR is faster and less expensive than NGS for focused, clinical assays.
- Analytical Robustness: qPCR has well-established LOD/LOQ characteristics and is easier to validate to clinical-lab standards.
- Clinical Utility: For targeted pathogen detection and management decisions, a focused qPCR panel is generally more practical than broad NGS profiling.
NGS is useful for discovery and broad microbiome research, but for routine, actionable diagnostics we select qPCR.
Unique Biosciences™ provides a saliva collection tube, accompanied by detailed sample collection instructions (see PDF for full details).
Within the temperature range of 4–35°C, target DNA from pathogens is preserved for up to 2 weeks, and the pathogenic bacterial counts remain stable, with no significant impact on quantitation within our validated time window.
Typical lab turnaround is 2 business days from receipt. Expedited reporting options may be available. Results delivery begins once the sample passes receipt QC.
Clinical exams and radiographs assess tissue and bone status but do not quantify microbial risk. UniquePerioSignature™ complements the exam by revealing pathogen load and microbial risk that may precede or exacerbate clinical disease, helping tailor antimicrobial choices and monitoring.
Microbial imbalance can exist before obvious symptoms. Early detection of elevated pathogen counts enables preventive interventions, personalized maintenance, and closer monitoring to prevent disease progression.
High pathogen counts are a risk factor for prosthetic/implant failure and peri-implant disease. Clinicians should consider treating/modulating infection (targeted debridement, antimicrobial therapy, or delaying elective procedures) before major restorative or implant treatments. UniquePerioSignature™ results should be integrated into the overall clinical assessment. Unique Biosciences™ provides treatment recommendations based on the individual patient’s report.
Routine oral hygiene is essential, but targeted microbial data helps identify patients who, despite good hygiene, can harbor high levels of pathogenic species and may benefit from specific interventions (antimicrobials, probiotics, or increased recall frequency). Testing optimizes resource use and improves outcomes.
Follow-up testing is recommended to confirm microbial reduction and guide maintenance frequency. Typical practice: test 6-12 weeks post-therapy — see clinical guidance.
Pricing varies by market and channel. Our panel is positioned to be cost-competitive with other targeted qPCR periodontal tests while delivering clinical quantitation and rapid turnaround. For current pricing and any clinician/lab discounts, contact [sales email / pricing page link].
Compared to broad NGS microbiome tests, UniquePerioSignature™ is faster, less expensive, and provides clinically actionable quantitative results for validated periodontal pathogens. Compared to other targeted qPCR assays, we emphasize rigorous validation, clinician-focused reporting, and an optimized sample workflow for routine dental practice.
- 5-Plex qPCR Efficiency: Quantify all five key periodontal pathogens in a single qPCR reaction.
- No DNA Extraction Needed: Proprietary saliva preservative stabilizes DNA and is compatible with direct qPCR, eliminating extraction kits and labor.
- Focused Detection: Targets only the five most clinically relevant pathogens, avoiding unnecessary tests.
- Stable Sample Transport: Preservative keeps DNA intact for up to 2 weeks at temperatures up to 35°C, avoiding cold-chain shipping.
- Direct marketing strategy engages clinicians and consumers directly, reducing marketing costs.
These combined advantages allow us to deliver a high-quality, science-backed diagnostic test at a significantly reduced cost.
Available through participating dental clinics and directly via our lab services. For a current list of participating clinics and shipping regions, see [link] or contact [contact info].
Whole saliva collected into the supplied tube (non-invasive, simple collection). Check the kit instructions.
Kits are shipped to clinics/patients or supplied by participating dental offices. You can order kits through [order link or contact].
- Do not eat, brush, or use mouthwash for 30 minutes prior to collection.
- Rinse your mouth gently with water if instructed, then wait 15 minutes.
- Spit into the provided tube until the indicated volume is reached.
- Seal, label, and package per kit instructions and return using the provided shipping materials.
First thing in the morning before eating or oral care is preferred; otherwise follow the kit recommendation (typically at least 30 minutes after any oral activity).
Typical required volume: 1-2 mL. See the tube fill line in the kit.
No. Do not eat during or immediately before collection. Follow the fasting window printed in the instructions (commonly 30–60 minutes).
Small sips of water more than 5–10 minutes before collection are generally acceptable. Avoid drinks immediately before collecting. Follow the kit instructions.
No. Avoid coughing up or mixing sputum. The sample should be saliva only.
Minor traces of blood are usually acceptable, but samples with visible blood should be noted and the clinic/lab informed. If bleeding is excessive, delay collection until bleeding subsides.
Sampling may be self-collected by the patient or performed by a clinician/trained staff at a dental office.
Quantitative counts for each target pathogen plus an interpretation: High Risk/Medium Risk/Healthy level or clinician cutoffs, with recommended clinical actions (monitoring, targeted therapy, re-testing). Results are intended to be used in conjunction with clinical exams and radiographs.
Reports are delivered securely via our online portal to the ordering clinician and (if permitted) to the patient. Printed or PDF reports can be provided on request.
No. UniquePerioSignature™ is an adjunctive diagnostic tool — it should be interpreted together with the full clinical assessment (probing, radiographs, systemic health, and patient history). Unique Biosciences™ also provides treatment recommendations based upon the test outcome.
Many patients can use FSA/HSA for diagnostic laboratory testing, but policies vary. Check with your plan administrator or our billing team.
Our laboratory operates under CLIA-certified clinical laboratory standards (CLIA# 45D2313828).
We maintain HIPAA-aligned privacy and security practices. Patient data is stored in secure, access-controlled systems with encryption. We only share data with authorized parties and for the purposes allowed by the patient and ordering clinician.
No. We do not sell individual patient or clinic data. Aggregated, de-identified data may be used for internal R&D or publishing aggregated findings with privacy safeguards.
Shipping cost policy is business-specific. Typical options: patients pay return shipping or billing can be arranged through the ordering clinic; bulk orders or partner clinics may receive subsidized shipping.
- Validation summary (LOD, LOQ, linearity, reproducibility)
- CLIA certificate
- Sample collection card (PDF)
- Suggested clinician interpretation guide and treatment recommendation