Frequently Asked Questions

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.

UniquePerioSignature™ gives clinicians multiplex quantitative, pathogen-specific information for periodontal disease from a non-invasive saliva sample so they can support clinical assessment, treatment planning, and longitudinal monitoring.

It's 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 together with interpretive information intended to support clinical decision-making by qualified healthcare professionals.

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 are well-described in the scientific literature in association with periodontal disease. 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).

View the validation summary (PDF)

Sensitivity and specificity depend on the pathogen and the clinical cutoffs used. Our internal validation demonstrates clinically acceptable sensitivity and specificity for each target.

View the validation summary (PDF)

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.

• 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.

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.

Several innovations let us offer a highly competitive price per test without compromising accuracy or reliability:

1. 5-plex qPCR efficiency — we quantify all five key periodontal pathogens in a single qPCR reaction, reducing reagent use, run time, and machine occupancy
2. No DNA extraction needed — our proprietary saliva preservative stabilizes DNA and is fully compatible with direct qPCR, eliminating extraction kits and associated labor
3. Focused detection — targeting only the five most clinically relevant pathogens avoids unnecessary testing of dozens of microbes
4. Stable sample transport — our preservative keeps target pathogen DNA intact for up to two weeks at temperatures up to 40°C, so standard shipping is sufficient
5. Lean marketing — we focus on direct engagement with clinicians and consumers rather than a large marketing team

Whole saliva is collected into the supplied tube — non-invasive and simple. Kits are shipped to clinics or patients, or supplied by participating dental offices; you can order kits through us.

View the sample collection instructions (PDF)

Within the temperature range of 4–35°C, target DNA from pathogens is preserved for up to two weeks, and the pathogenic bacterial counts remain stable, with no significant impact on quantitation within our validated time window.

Typical lab turnaround is two business days from receipt. Expedited reporting options may be available. Results delivery begins once the sample passes receipt QC.

1. Do not eat, brush, or use mouthwash for 15 minutes prior to collection (follow kit instructions)
2. Spit into the provided tube until the indicated volume is reached
3. 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 15 minutes after any oral activity). A detailed instruction card is included with every kit.

Typical required volume is 1–2 mL; see the tube fill line in the kit. 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, but avoid drinks immediately before collecting.

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 or lab informed, since blood can affect some analyses. If bleeding is excessive, delay collection until it subsides.

Sampling may be self-collected by the patient (following instructions) or performed by a clinician or trained staff at a dental office, depending on the service channel.

Clinical exam 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. Identification of elevated pathogen levels may provide additional information that clinicians can consider when determining appropriate preventive care, maintenance, and monitoring.

High pathogen counts are a risk factor for prosthetic or implant failure and peri-implant disease. Clinicians should consider treating or modulating the infection (for example, targeted debridement, antimicrobial therapy, or delaying elective procedures) before major restorative or implant treatments. Results should be integrated into the overall clinical assessment — Unique Biosciences™ provides clinician-directed Clinical Decision Support information intended to supplement, not replace, independent professional judgment.

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 provides additional microbial information that may support clinical decision-making.

Follow-up testing is recommended to confirm microbial reduction and guide maintenance frequency. Typical practice is to retest 6–12 weeks post-therapy.

You receive quantitative counts for each target pathogen plus an interpretation — High Risk, Moderate Risk, or Healthy against clinician cutoffs — with recommended clinical actions (for example, monitoring, targeted therapy, or re-testing). Reports are delivered securely via our online portal to the ordering clinician and, if permitted, to the patient. Results are intended to be used alongside clinical exam and radiographs.

No. UniquePerioSignature™ is an adjunctive diagnostic tool — it should be interpreted together with the full clinical assessment (probing, radiographs, systemic health, and patient history) to form a treatment plan. Unique Biosciences™ also provides a treatment recommendation based on the test outcome.

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 or lab discounts, contact support@uniquebiosciences.com.

Our laboratory operates under CLIA-certified clinical laboratory standards (CLIA# 45D2313828).

Shipping cost policy is business-specific. Typical options include three complimentary shipping labels when clinics prebuy 10 kits, and bulk orders or partner clinics may receive subsidized shipping.

Contact us for more detail.

We can share a test result sample, our validation summary (LOD, LOQ, linearity, reproducibility), CLIA certificate, sample collection card, and a suggested clinician interpretation and treatment guide.

Request these materials

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 purposes allowed by the patient and ordering clinician. We do not sell individual patient or clinic data.