Introducing
Oral Health Pro™
with CancerDetect® Oral & Throat†
Empowering dental professionals with essential oral health insights that lead to optimal, personalized treatment solutions.
Our groundbreaking oral health test is revolutionizing dentistry by providing dental professionals with an unprecedented level of insight into their patients' health.
Interested in offering Oral Health Pro with CancerDetect to your patients?
If you are a patient, please contact your dental professional for more information or email us at OralCarePro@viome.com
Currently not available in the State of New York.
Test details
Sample collection
Sample type: Saliva
Our at-home saliva collection kit makes it easy for your patients to collect their sample and mail it to our lab in a prepaid envelope. Your patients' digital results will arrive in up to 4 weeks.
What's measured with this test
This test measures microbial and human gene expressions of the oral microbiome and human cells in your patient’s saliva to identify early biomarkers of periodontitis disease, caries, gum inflammation, and other risks for oral diseases.
This test also 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.
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 few false-negative results, and thus fewer disease cases 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 few false-positive results and, thus, few false alarms.
![[Icon] CLIA](/cdn/qk4l4jfatr3e/7khntybZq95vAusqYI68yO/1d7f0bab7b2cdeba47057d04b325cf2d/CLIA.svg?w=3840&q=70)
CLIA-Certified Lab
Become a leader in oral healthcare with Viome
Benefits to Patient
Benefits to Dentists & Hygienists
Benefits to the Practice
What's included with this test
With Viome's oral health test, you can go above and beyond the standard of care to detect early signals of cancer, oral diseases, and systemic diseases with unparalleled accuracy.
This test is powered by Viome's proprietary RNA sequencing technology and state-of-the-art AI platform, which can identify underlying signals that other tests may miss. By offering this innovative test, you can differentiate your practice as a leader in cutting-edge oral health care.
Our at-home saliva collection kit makes it easy for your patients to collect their sample and mail it to our lab.
Your patient’s analysis will include six functional health scores and their CancerDetect results.
Our reports include a personalized treatment plan for your patient so you can make better, more informed decisions for the next steps.
The oral connection to overall health
Significant associations between oral health status and a number of systemic diseases have been established, including, but not limited to, cardiovascular diseases, Alzheimer's disease and dementia, obesity, diabetes and metabolic disorders, rheumatoid arthritis, and several cancers.
Oral Health Pro with CancerDetect® Oral & Throat is a preventative health test paving the way for a future where dentistry and overall health. By providing dental professionals with this revolutionary tool, Viome is empowering you to offer your patients unparalleled care, better outcomes, and, ultimately, a healthier life.
Cancer
Up to 50% greater risk of developing Cancer including oral, esophageal, lung, colorectal, pancreatic, and breast cancers.
Source: The American Academy of Oral Systemic Health
Heart Attacks and Strokes
Up to 50% of heart attacks and strokes are triggered by oral pathogens.
Source: Circulation (2013)
Diabetes
95% of Americans with Diabetes also have periodontal disease. Periodontal disease lowers glycemic control.
Source: The American Academy of Oral Systemic Health
Alzheimer’s Disease
70% More likely to develop Alzheimer’s Disease in people who suffer from gum disease for more than 10 years.
Source: Alz Res Therapy (2017)
Adverse Pregnancy Outcomes
7x increased risk of Adverse Pregnancy Outcomes including preterm birth and low birth rate.
Source: The American Academy of Oral Systemic Health
Premature Death
12% higher risk of Premature Death in women who have a history of periodontal disease.
Source: Journal of the American Heart Association (2017)
Early detection saves lives
CancerDetect
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.
A solution for earlier detection
Oral cancer (OC) is a major subtype of head and neck cancers.
400,000 new cases of oral cancers every year in the US
This is expected to increase by nearly two-thirds by 203510
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.
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 consumption12.
Tobacco use can include consuming tobacco products by smoking, chewing, vaping, etc.
Increasing age and infection with human papillomavirus (HPV) are additional risk factors for oral and throat cancer, and the risk increases more rapidly after 50 years of age13.
Even though throat cancers are the most common HPV-related cancers in the United States, no early detection strategy for OPSCC is in place for HPV-positive individuals14.
Additional insights included with Oral Health Pro™
Oral Health Scores
Viome's oral health test provides dental professionals with a unique set of oral health scores focused on the unique activity of the oral microbiome of every patient. Unlike other tests that focus on composition, our RNA sequencing technology enables us to measure the molecular activity of the oral microbiome and human cells in your patient’s mouth and identify early biomarkers of periodontitis disease, caries, gum inflammation, and other risks of oral and systemic diseases.
With these scores, you can monitor the underlying signals of poor oral health and disease over time, and take action with a personalized treatment plan that addresses your patient's unique needs. This is the only test that translates oral microbiome activity into actionable health scores, allowing you to provide your patients with the most comprehensive care possible.
Provides a range of insights into oral health based on saliva, including:
![[Test] Sample Image](http://images.ctfassets.net/qk4l4jfatr3e/2jm5IoqMnkJQQZRu90ZwGZ/880ea85949d452c0d80906897e892f46/sample_image.png)
Gum Health
The gum health score quantifies the abundance of microbial activities present in the oral cavity that may pose a risk to worsening/ or deterioration of your gums. The ability of these activities to chronically settle in the mouth depends on their properties, host defenses, and the composition of the oral microbiome. Chronic exposure to these microbial activities poses a risk for development of gingivitis and periodontitis, which can contribute to exacerbation of underlying conditions and also poses a risk for worsening oral health. A significant increase in these microbial activities signals an opportunity to address a dysbiotic microbiome and strengthen impaired host defenses.
Cariogenic Activity
The dental health score quantifies the abundance and expression of cariogenic and anti-cariogenic microbial species in the oral cavity. The data observed help identify microbial species which contribute to dental cavities. It also identifies cariogenic activities involved in carbohydrate metabolism, acid promotion, and chelation which would contribute to degradation of the teeth.
Breath Odor
The Breath Odor Health score is an assessment of the microbiome balance with respect to malodor due to specific microbial activities from across Proteobacteria, Actinobacteria, Bacteroidetes, and Firmicutes. The microbial activities measured by this score are associated with malodorous compounds like polyamines and sulfur-containing molecules, as well as an acidic environment which augments the malodorous effect. A low Breath Odor Health score signals an opportunity to address a dysbiotic microbiome and improve breath conditioning.
Pathobiont Activity
The Pathobiont Health score indicates the accumulation of pathobionts in the oral cavity which may negatively impact health (see partial list of species on the next page). Pathobionts are microbial species (bacteria, fungi, or protozoa) that, under normal circumstances, either do not cause any harm or provide a benefit to the human host. However, they can become pathogenic (cause a disease) under certain environmental conditions, such as dysbiosis2. The ability of these pathobionts to accumulate and impact health depends on their properties, host defenses, and the composition of the oral microbiome. Chronic oral conditions, such as gingivitis and periodontitis, occur when the pathobionts are left unchecked, allowing them to flourish and negatively impact health. In some people, these oral conditions can progress to more severe systemic diseases, such as arthritis, heart disease, and Alzheimer’s. A significant increase in the pathobionts signals an opportunity to address a dysbiotic microbiome and strengthen impaired host defenses.
Fungal Activity
The fungal activity score quantifies the abundance of cancer-associated fungi (Candida, Malassezia, and certain species of Saccharomyces). The ability of these fungi to chronically settle in the mouth depends on their properties, host defenses, and the composition of the oral microbiome. Chronic fungal infections occur when one or more species are left unchecked, allowing them to flourish. Our data show that increased abundance of the fungi assessed in this score are associated with oral and throat cancer. A significant increase in these fungal species signals an opportunity to address a dysbiotic microbiome and strengthen impaired host defenses.
Genotoxic Activity
Within healthy oral microbiomes, Lactobacillus species are found in small quantities, while many Streptococcus species are detected in moderate quantities. When host defenses are impaired, these species accumulate to large quantities, and this increase is associated with microbial production of reactive oxygen species, formaldehyde, acetaldehyde, and acetoin. These compounds have genotoxic potential, and therefore, large quantities of these microbes may pose a health risk.
Personalized Recommendations for Treatment
We provide personalized oral health treatment protocols that allow oral health professionals to customize their patients' oral care journey. Our treatment recommendations offer three support categories: Lifestyle and Oral Hygiene support, Nutritional support, and Professional Treatment.
The Lifestyle and Oral Hygiene Support category may recommend modifying high-risk behaviors or introducing specific hygiene practices and provide personalized recommendations for toothpaste, probiotic lozenges, oral rinses, medicated floss, and antimicrobial gums intended to support oral health.
The Nutritional Support category provides supplement recommendations and dietary modifications intended to reduce cancer risk, address nutrient deficiencies, and provide specific nutrients to both oral microbes and human cells.
The Professional Treatment category includes treatment recommendations intended to prevent and manage oral health conditions. It may include periodontal care, oral cancer detection, and prescription oral care products or medications.
Interested in offering Oral Health Pro with CancerDetect Oral & Throat to your patients?
If you are a patient, please contact your dental professional for more information or email us at OralCarePro@viome.com
FDA breakthrough device designation granted for accelerated review.
* This test is not an FDA-approved or cleared device
"Viome’s holistic and scientific approach to health will revolutionize how people approach oral hygiene and care."
Edward Zuckerberg D.D.S., F.A.G.D.
Oral Health Advisor
Our science sets us apart and is revolutionizing the future of early diagnostics
We employ 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 oral diseases and cancer.
This allows us to reimagine comprehensive oral care with our groundbreaking early detection test and empower patients everywhere with a convenient and accessible early testing solution.
Frequently Asked Questions
What is the OHPro with CancerDetect test?
It is a painless, non-invasive way to detect oral and throat cancer early and identify risks for other oral and associated systemic diseases. Early detection of oral cancer and systemic diseases through saliva testing can lead to more effective treatment options and better outcomes. Risk scores for other oral and associated systemic diseases provide a way to prevent more severe diseases through personalized treatment considerations.
How does the test work?
The test involves collecting a small amount of saliva from the patient, which is then sent to a laboratory for analysis. The lab will extract RNA molecules from the saliva sample using a technique called metatranscriptomics to measure the levels of specific RNA molecules from microbes and the human host associated with oral and throat cancer and other oral health risk factors. Then these RNA molecules are analyzed for similarity with molecular biomarkers associated with various conditions; these biomarkers having been discovered using proprietary artificial intelligence / machine learning algorithms.
Is the test accurate?
Studies have shown that this test has a high degree of accuracy, with a sensitivity of 90% and a specificity of 95% for oral and throat cancer.
Who should consider getting the Oral Health Pro with Cancer Detect test?
According to the American Cancer Society (ACS), adults who use tobacco, drink alcohol or have been infected with HPV are at a high risk of developing oral cavity and throat cancers. Age is also a risk factor, and the risk increases more rapidly after age 50 and peaks between ages 60 and 70 (NIH-National Institute of Dental and Craniofacial Research). Other risk factors include family history or previous history of oral or throat cancer, excess body weight, and some genetic syndromes like fanconi anemia or dyskeratosis congenita.
Does insurance cover the test?
It depends on the individual insurance plan. Some plans may cover the cost of the test, while others may not. Patients should check with their insurance provider to see if the test is covered.
Are there any risks or side effects associated with the test?
This test is non-invasive and has no direct side effects. However, the test can have false positives and false negatives.
How often should someone get this test?
The testing frequency will depend on individual risk factors and medical history (see the other FAQ on specific risk factors). For individuals with a higher risk, it is advisable to undergo the test biannually, i.e. twice a year. It is generally recommended that patients who do not present a high risk of developing oral or throat cancer undergo an annual oral health overall wellness test. Patients should consult their healthcare provider to determine how often they should get tested.
How does our approach differ from the standard approach in dentistry?
Our approach is different in that we use metatranscriptomic and AI-based molecular diagnostics to detect damage that is not visible with current technologies and molecular markers to predict disease risk before damage is done. We also address overall health and wellness taking a personalized approach to health solutions due to biochemical individuality, and using a systems biology approach to health.
How does this differ from Oral DNA or Direct Diagnostics?
Unlike Oral DNA or Direct Diagnostics, Viome’s Oral Health Pro with CancerDetect uses RNA testing and AI/machine learning to detect biomarkers for cancer and other oral diseases that have associations with systemic diseases. Using these techniques, Viome’s platform is uniquely able to detect biomarkers across a wide spectrum of health conditions impacted by the gene expression of microbes and human host cells in the oral cavity.
How does the patient collect the sample?
The patient will be asked to provide a saliva sample by spitting into a collection container, which will be provided through Viome Life Sciences and our lab. The ideal way to collect the sample is first thing in the morning, before brushing teeth or consuming food and drinks.
How does it benefit the patient?
The test benefits the patient by providing early detection of cancer and other oral health issues known to be associated with systemic health issues, which can lead to earlier treatment and better outcomes. It is a painless, non-invasive way to detect oral cancer and systemic diseases early. Early detection of oral cancer, other oral health issues, and their associations with systemic diseases through saliva testing can lead to more effective personalized treatment options and better outcomes. This test could reduce the need for invasive procedures like biopsies and can help patients avoid unnecessary treatments. It is convenient and can be done quickly in a dental office or home, making it easier for patients to get tested regularly. This test provides peace of mind for patients experiencing oral health issues and may be at risk of developing cancer.
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 (approval in progress). 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
Banavar G, Ogundijo O, Julian C, Toma R, Camacho F, Torres PJ, et al. Detecting salivary host-microbiome RNA signature for aiding diagnosis of oral and throat cancer. (in preparation / under review) 2022.
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.
National Cancer Institute Surveillance, Epidemiology and End Results Program. 2021. (Cancer Stat Facts: Oral Cavity and Pharynx Cancer).
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.
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.
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.
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.
Irfan M, Delgado RZR, Frias-Lopez J. The Oral Microbiome and Cancer. Front Immunol. 2020;11:591088.
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.
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.
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).
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.
Moyer VA. Screening for Oral Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160(1):55–60.
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.