CancerDetect Test for Oral & Throat Cancer
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.
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Detect biomarkers associated with early-stage oral & throat cancers
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Substantially higher accuracy over current screening methods
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Easy-to-use at-home test and guided experience
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Healthcare provider consultation is available when needed
Test Details
Saliva collection at home
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.
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Cancer-free specificity is ≥ 95% *
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OSCC sensitivity is ≥ 90% *
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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:
Do you currently consume any tobacco products? Example: cigarettes, vaping, chewing tobacco.
(or)
Do you have any history of consuming any tobacco products? Example: cigarettes, vaping, chewing tobacco.
*You need to be at or over the age of majority in your state (most states it's 18)
Oral and Throat Cancer Detection Test built on
Viome platform, designated Breakthrough Device for accelerated Review by FDA
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
The overall 5-year survival rate for people with late stage oral cancer is 40%3
84%
survival rate with early detection
If diagnosed at an early stage, the overall 5-year survival rate is 84%4
28%
of patients get diagnosed early
Unfortunately, with today’s practices, only 28% of patients are diagnosed at an early stage3
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
At-risk individuals
Major risk factors for the development of oral and throat cancer include tobacco use and alcohol consumption.
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75% of oral cancers in the United States are attributable to tobacco use and alcohol consumption.
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Tobacco use can include consuming tobacco products by smoking, chewing, vaping, etc.
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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.
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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.
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40,000 new cases of oral cancers every year in the US
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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
NEWS ARTICLE
Oral and Throat Cancer Detection Test built on Viome platform, designated Breakthrough Device for accelerated Review by FDA
Our testing delves beyond your DNA to explore the dynamic world of gene expression (RNA), offering a real-time snapshot of your health's inner workings. With our unique technology, we unlock personalized insights tailored specifically to your current needs, pinpointing the exact foods, supplements, and biotics that benefit you most. Let us steer you towards making informed health decisions based on true data, moving away from one-size-fits-all guidance and guesswork.
Early Testing Process
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.
How this test can help
FAQs
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.
Anyone who answers yes to any of the following individual questions below should test
Are you 50 years of age or older?
or
Are you 18 years of age* or older AND:
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Do you currently consume any tobacco products? Example: cigarettes, vaping, chewing tobacco.
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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
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.
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.
The result will not be shared directly with your doctor. Your analysis will be reviewed by a healthcare provider licensed in your state, and delivered digitally in a printable form (PDF) through your account on our secure platform, which you can share with your doctor.
If molecular features are detected, you will receive a call from the same healthcare provider who reviews your analysis. You could also receive the hard copy via certified mail if the provider could not reach you for consultation.