CancerDetect® Oral & Throat is the first at-home test of its kind to detect biomarkers associated with early-stage oral and throat cancer. This simple-to-use yet revolutionary test takes only a few minutes to collect and mail a sample and includes healthcare provider guidance when needed. Eligible individuals can now test with the confidence of high accuracy to detect biomarkers associated with oral and/or throat cancer.
Viome’s CancerDetect Test is not an FDA-approved or cleared test.
Oral and Throat Cancer Detection Test built on
Viome platform, designated Breakthrough Device for accelerated Review by FDA
Test Details
Sample collection
Saliva collection at home
Measures
This test detects molecular features associated with Oral Cancer (Oral Squamous Cell Carcinoma or OSCC), and/or Throat Cancer (Oropharyngeal Squamous Cell Carcinoma or OPSCC) in saliva samples.
Detection rates
Cancer-free specificity is ≥ 95% *
OSCC sensitivity is ≥ 90% *
OPSCC sensitivity is ≥ 90% *
Sensitivity refers to a test's ability to designate an individual with a disease as positive. A highly sensitive test means that there are few false-negative results, and thus fewer cases of the disease are missed. Specificity refers to a test's ability to designate an individual who does not have a disease as negative. A highly specific test means that there are few false-positive results, and thus few false alarms.1
Who this test is for
If you can answer yes to any of the following questions, this test is appropriate for you.
Are you 50 years of age or older?
Are you 18* years of age or older AND:
or
*You need to be at or over the age of majority in your state (most states it's 18)
Early detection saves lives
Detecting cancer early is important. The earlier it is detected, the higher the chance of survival.
40%
survival rate
with late detection
84%
survival rate
with early detection
28%
of patients get
diagnosed early
Reliable results that you can trust
Our CancerDetect® - Oral & Throat test detects molecular features of oral & throat cancers even in early stages when it is more treatable. The test delivers the highest accuracy currently possible and surpasses the current standard of care - the visual and tactile exam.
90% Sensitivity
Sensitivity refers to a test's ability to designate an individual with a disease as positive. A highly sensitive test means that there are few false-negative results, and thus fewer cases of the disease are missed.
95% Specificity
Specificity refers to a test's ability to designate an individual who does not have a disease as negative. A highly specific test means that there are few false-positive results, and thus few false alarms.
At-risk individuals
Major risk factors for the development of oral and throat cancer include tobacco use and alcohol consumption.
75% of oral cancers in the United States are attributable to tobacco use and alcohol consumption.12
Tobacco use can include consuming tobacco products by smoking, chewing, vaping, etc.
Older age, HPV (human papillomavirus) infection, and excess body weight are additional risk factors for oral and throat cancer, and the risk increases more rapidly after 50 years of age.13
Even though throat cancers (OPSCC) are the most common HPV-related cancers in the United States, no early detection strategy for OPSCC is in place for HPV-positive individuals.14
A solution for earlier detection
Oral cancer is a major subtype of head and neck cancers.
40,000 new cases of oral cancers every year in the US
This is expected to increase by nearly two-thirds by 203510
Currently, oral cancer is hard to detect in the early stages because of the lack of effective early diagnostic tools, resulting in late diagnosis, leading to poor prognosis and low survival rates.
The performance characteristics of visual screening are operator-dependent, with sensitivity ranging from 25% to 100%, with the study most generalizable to the United States demonstrating a sensitivity of 74%.11
What’s included with CancerDetect® - Oral & Throat
Instructions to guide your testing experience.
Everything you need to collect your saliva sample at home
A digital report that you can print and review your results
Prepaid First Class USPS label and mailing envelope
Consultation with a healthcare provider to help you better understand
Guiding you through next steps
IF NOT DETECTED
If no molecular features are detected, we recommend talking to your healthcare provider about best practices for your health and when you should plan to screen with CancerDetect® - Oral & Throat again.
IF DETECTED
If molecular features are detected, a healthcare provider will contact you by phone as soon as analysis is completed to discuss your results and next steps; if they cannot reach you within 14 days, a hard copy of your result will be sent to your home address via certified mail.
NEWS ARTICLE
Oral and Throat Cancer Detection Test
built on Viome platform, designated Breakthrough Device for accelerated Review by FDA
Early Testing Process
1
Complete the eligibility form and follow simple steps to order your test. A healthcare provider will review your test request in 48 hours.
3
Collect your saliva sample and use a prepaid shipping label to mail to our CLIA-certified laboratory
5
Expect your result within 4 weeks: after a healthcare provider from our partner, PWNHealth, reviews your analysis, a printable report (PDF) will be available on my.viome.com. If molecular features are detected, the same provider will call you to guide you through your report.
Your test includes everything required to collect and mail your saliva sample
Your test includes detailed instructions to guide your testing experience
No changes to your diet or medication is necessary
Your test is delivered right to your home
Minimum preparation required
![[FBI 3.0] How Viome compares
to other types of tests - Image](/cdn/qk4l4jfatr3e/3St4zgmrvnydwFXq7vERKO/d73da0ca632afb5cae016fca3b0d844e/viome_feb2018_hi-res_v1-13_1.jpg?w=3840&q=70)
Our science sets us apart and is revolutionizing the future of early diagnostics
We employed our unique RNA analysis technology and breakthrough machine learning techniques to accurately discover the interactions between microbial activities and human gene expression in the progression of cancer.
This allows us to completely reimagine early detection with our groundbreaking early cancer-detection test and empower patients everywhere with a convenient and accessible early testing solution.
CLIA certified
Your sample analysis is performed in a US laboratory that is certified to meet CLIA standards. A CLIA-certified lab must meet certain quality standards and ensure the accuracy and reliability of your results.
Privacy & data
To ensure the confidentiality of your data, we separate users’ personally identifiable information (PII) from protected health information (PHI) and use multiple layers of encryption and access protection. We do not provide your information or results to employers or health insurance. Viome will never sell your data.
FAQs
How does the CancerDetect® Oral & Throat test work?
CancerDetect® Oral & Throat utilizes the expression level of human genes and microbial species and functions in the saliva sample to detect molecular features associated with oral and throat cancers. CancerDetect® Oral & Throat provides an output that classifies a person as being likely to have oral cancer and/or throat cancer or not. Your results inform of any detected signatures of oral and/or throat cancer. If a signature for oral and/or throat cancer is detected, you will receive a call from a healthcare provider who will guide you to the next steps.
The test is not intended for definitive diagnosis and should be interpreted in conjunction with other laboratory and clinical data available to the clinician and relevant guidelines on the decision for confirmatory diagnosis, such as a biopsy.
Who should take this test?
Anyone who answers yes to any of the following individual questions below should test
Are you 50 years of age or older?
ORAre you 18 years of age* or older AND:
Do you currently consume any tobacco products? Example: cigarettes, vaping, chewing tobacco.
OR, did you consume tobacco products in the past? Example: cigarettes, vaping, chewing tobacco.
*Age of majority varies by state. You need to at or over the age of majority in your state to purchase CDOT
What should I expect if I take the test and my result is detected?
A healthcare provider licensed in your state will review your result and provide a consultation over the phone to discuss the test result, provide educational information, and talk about your next steps. However, no medical advice, treatment, or prescriptions will be provided.
Do I need to be referred by a doctor to take this test?
No. However, a healthcare provider will review your test request based on clinical appropriateness and make a final decision on whether you should be taking the test. This process normally takes up to 2 business days and we will email you once the provider makes the final decision to process your order accordingly.
How do I share my results with my doctor?
Important Safety Information
CancerDetect - Oral & Throat is a lab-developed test (LDT) performed in our Clinical Laboratory located in Bothell, Washington. The Laboratory is designed to meet all federal and state regulatory, quality and CLIA criteria. The test is intended for use as a diagnostic aid in the detection of molecular features associated with OSCC and/or OPSCC. The test is ≥ 90% OSCC sensitive, ≥ 90% OPSCC sensitive and has a specificity of ≥ 95%.1
The CancerDetect - Oral & Throat test is recommended for use in adults with an elevated risk for oral & throat cancer such as those aged 50 or older or individuals who have a history of smoking, chewing tobacco, vaping, or using other forms of tobacco, heavy alcohol drinkers, or individuals with a high risk of HPV. The CancerDetect - Oral & Throat test does not detect all cancers and should be used in addition to routine cancer tests recommended by a healthcare provider. CancerDetect- Oral & Throat is intended to detect molecular features associated with cancer of the oral cavity or throat.
Results should be interpreted in the context of medical history, clinical signs and symptoms. A test result of “NOT DETECTED” does not rule out cancer, and best practices may recommend testing again after a period of time. A test result of “DETECTED” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging or biopsy) to confirm cancer. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur, as described in our scientific information.
References
1. Banavar G, Ogundijo O, Julian C, et al. Detecting salivary host-microbiome RNA signature for aiding diagnosis of oral and throat cancer. July 2022. https://doi.org/10.1101/2022.07.30.22278239
2. Banavar G, Ogundijo O, Toma R, Rajagopal S, Lim YK, Tang K, et al. The salivary metatranscriptome as an accurate diagnostic indicator of oral cancer. NPJ Genomic Medicine. 2021;6(1):105.
3. National Cancer Institute Surveillance, Epidemiology and End Results Program. 2021. (Cancer Stat Facts: Oral Cavity and Pharynx Cancer).
4. Peacock ZS, Pogrel MA, Schmidt BL. Exploring the Reasons for Delay in Treatment of Oral Cancer. J Am Dent Assoc. 2008;139(10):1346–52.
5. Mager D, Haffajee A, Devlin P, Norris C, Posner M, Goodson J. The salivary microbiota as a diagnostic indicator of oral cancer: a descriptive, non-randomized study of cancer-free and oral squamous cell carcinoma subjects. J Transl Med. 2005 Jul 7;3:27.
6. Su SC, Chang LC, Huang HD, Peng CY, Chuang CY, Chen YT, et al. Oral microbial dysbiosis and its performance in predicting oral cancer. Carcinogenesis. 2020;42(1):127–35.
7. Wang L, Yin G, Guo Y, Zhao Y, Zhao M, Lai Y, et al. Variations in Oral Microbiota Composition Are Associated With a Risk of Throat Cancer. Front Cell Infect Mi. 2019;9:205.
8. Irfan M, Delgado RZR, Frias-Lopez J. The Oral Microbiome and Cancer. Front Immunol. 2020;11:591088.
9. Hatch A, Horne J, Toma R, Twibell BL, Somerville KM, Pelle B, et al. A Robust Metatranscriptomic Technology for Population-Scale Studies of Diet, Gut Microbiome, and Human Health. Int J Genomics. 2019 Jan 1;2019:1718741.
10. Shield KD, Ferlay J, Jemal A, Sankaranarayanan R, Chaturvedi AK, Bray F, et al. The global incidence of lip, oral cavity, and pharyngeal cancers by subsite in 2012. Ca Cancer J Clin. 2017;67(1):51–64.
11. Kujan O, Glenny A, Oliver R, Thakker N, Sloan P. Screening programmes for the early detection and prevention of oral cancer. Cochrane Db Syst Rev. 2006;(3).
12. Blot WJ, McLaughlin J, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, et al. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988;11(48):3282–7.
13. Moyer VA. Screening for Oral Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160(1):55–60.
14. National Program of Cancer Registries SEER. Stat Database: U.S. Cancer Statistics Incidence Analytic file 1998–2017. United States Department of Health and Human Services, Centers for Disease Control and Prevention; 2020.