Viome CancerDetect — Oral & Throat
Test at home for peace of mind
Provider-reviewed saliva screen for oral and throat cancer biomarkers using Viome's RNA platform
Collection
At-home
Turnaround
Up to 5 weeks
Price
$599
Physician reviewed
Yes
Membership
Not required
About
Viome CancerDetect - Oral & Throat is an at-home saliva test that screens for molecular features associated with oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma. It uses Viome's RNA metatranscriptomic platform to analyze host gene expression and microbial activity in saliva, then runs the sample through Viome's CLIA-certified Bothell lab. The product has FDA Breakthrough Device designation and a built-in PWNHealth review before the kit ships and after lab analysis.
Every order is reviewed by a PWNHealth-licensed provider before the kit ships to assess clinical appropriateness. After lab analysis, a PWNHealth provider reviews the result. If molecular features are detected, the provider calls the patient to discuss the report and next steps.
What to Know
Signature approach
CancerDetect uses saliva RNA patterns to return a Detected or Not Detected result for oral and throat cancer-associated molecular features. A PWNHealth provider reviews clinical appropriateness before shipping, then reviews the result after lab analysis. If molecular features are detected, the provider calls the patient to discuss the report and next steps.
What sets it apart
- Provider-reviewed workflow. Every order includes pre-ship eligibility review and post-analysis result review through PWNHealth.
- RNA-based oral/throat screen. Viome applies its metatranscriptomic platform to host and microbial signals in saliva.
- Published performance claims. The product page cites 90% sensitivity for OSCC and OPSCC and 95% specificity in cancer-free samples, grounded in Banavar et al. 2023.
Before You Order
- Understand the regulatory status. FDA Breakthrough Device designation is meaningful, but it does not equal FDA approval or clearance.
- Plan for provider review. PWNHealth reviews the order before the kit ships and reviews results before release, so timing is different from Viome's wellness kits.
- Know the eligibility path. The product is intended for adults 50+, or adults at/above state age of majority with current or past tobacco exposure.
- Prepare for follow-up. A detected result still needs confirmatory clinical evaluation, such as imaging or biopsy, through a clinician.
What's tested
Panel focus
What's included
Biomarker categories
Oral Cancer Biomarkers (OSCC)
1 markerThroat Cancer Biomarkers (OPSCC)
1 markerWhat’s not included
CancerDetect does not include definitive diagnosis, treatment, prescriptions, ongoing medical care, HPV genotyping, biopsy, imaging, or coverage of cancers outside the oral cavity and oropharynx.
Reference ranges methodology
Performance claims on the product page: 90% sensitivity for OSCC, 90% sensitivity for OPSCC, 95% cancer-free specificity. The page frames these against a published meta-analysis of conventional oral examination (Essat et al. 2022) reporting 71% sensitivity (95% CI: 57%–81%) and 85% specificity (95% CI: 68%–94%) across 14 studies. Underlying validation: Banavar et al., Oral Oncology Vol. 145 (Oct 2023) and Banavar et al., NPJ Genomic Medicine 2021;6(1):105.
Pricing
Starting at
$599
$599 covers one CancerDetect - Oral & Throat kit, saliva collection materials, prepaid USPS First-Class return mailer, lab analysis at the CLIA-certified Bothell lab, PWNHealth eligibility review before shipping, PWNHealth result review after analysis, digital PDF report, and provider phone consultation if molecular features are detected.
Panel details
CancerDetect — Oral & Throat (one-time)
At Home saliva
Full kit, lab processing, both pre-ship and post-analysis PWNHealth provider review, PDF report, and post-result provider consultation if Detected. Promo code DETECT takes $300 off ($299 effective).
Expected first-year cost
$299/yr - $599/yr
In practiceReal-world pricing notes, add-ons, and coverage limits.
$599 is the list price, and the DETECT promo captured in source drops the order to $299 Affirm financing is available. The price covers the saliva kit, lab analysis, both PWNHealth provider reviews, the digital report, and a provider phone call if molecular features are detected. There is no subscription path. HSA/FSA eligibility is not advertised on the CancerDetect page, and insurance is not accepted.
How it works
- 1
Submit eligibility form (provider review in 48 hours)
Complete the eligibility questionnaire and place the order. A PWNHealth-licensed healthcare provider reviews the request for clinical appropriateness within 48 hours (up to 2 business days) before the kit ships. The order is not processed until that review clears.
- 2
Register the kit on arrival
Once the kit arrives, register it with the unique kit ID on cancerdetect.viome.com to link the sample to the patient account.
- 3
Collect saliva at home, mail back
Collect the saliva sample at home using the included materials. No fasting, no diet or medication changes, minimum preparation. Use the prepaid First-Class USPS label and mailing envelope to ship the sample to Viome's CLIA-certified Bothell, WA lab.
- 4
Complete health questionnaires
Complete the CancerDetect — Oral & Throat health questionnaires on my.viome.com so the lab and PWNHealth provider have the medical context for analysis and review.
- 5
Results in up to 5 weeks (provider call if Detected)
After lab analysis, a PWNHealth provider reviews the result and a printable PDF report is delivered through my.viome.com. If molecular features are detected, the same provider calls the patient to discuss results and next steps; if unreachable within 14 days, a hard copy is sent by certified mail.
Frequently asked questions
Is Viome CancerDetect FDA-approved?
The test holds FDA Breakthrough Device designation, which can accelerate review for devices addressing serious unmet needs. It is offered as a lab-developed test performed in Viome's CLIA-certified Bothell lab and is intended as a screening aid, not a definitive diagnostic.
Who is eligible to order the test?
Adults aged 50 or older qualify regardless of tobacco history. Adults at or above the state age of majority qualify if they currently use tobacco products or have a history of tobacco use. Every order is reviewed by PWNHealth for clinical appropriateness before the kit ships.
How is the sample collected?
You collect saliva at home using materials included in the kit and return the sample to Viome's CLIA-certified Bothell lab with the prepaid USPS envelope. No lab visit or phlebotomy is needed.
How accurate is it?
The product page reports 90% sensitivity for OSCC, 90% sensitivity for OPSCC, and 95% specificity in cancer-free samples, citing Banavar et al., Oral Oncology Vol. 145 (October 2023). The page frames these numbers against a published meta-analysis of conventional oral examination (Essat et al., Head & Neck 2022), which reported 71% sensitivity and 85% specificity across 14 studies.
What happens if my result is Detected?
A PWNHealth healthcare provider licensed in the patient's state calls to discuss the result, provide educational information, and talk through next steps. A detected result still needs confirmatory diagnostic evaluation such as imaging or biopsy. If the provider cannot reach the patient within 14 days, a hard copy of the report is mailed by certified mail.
How long until I get results?
Up to 5 weeks total. The timeline includes pre-ship eligibility review by PWNHealth, lab analysis after the sample arrives, and post-analysis provider review before the report is released to the my.viome.com portal.
Does insurance or HSA/FSA cover it?
Insurance is not accepted. HSA/FSA eligibility is not advertised on the CancerDetect product page. Affirm financing is available at checkout.
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