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.


  • Detection of biomarkers associated with oral and throat cancers with unmatched accuracy, including early stages, with a specificity of 95% and a sensitivity of 90%
  • A comprehensive overview of a patient's oral health
  • Easy, at-home collection and easy-to-implement treatment plan
  • Powered by our proprietary RNA sequencing + AI technology for unprecedented insight into oral health



Interested in offering Oral Health Pro with CancerDetect to your patients?





Or email us for more information 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


CLIA-Certified Lab




Become a leader in oral healthcare with Viome

Benefits to Patient

  • Give your patients the highest standard of personalized care that exists.
  • Help patients reduce their risk of chronic & systemic diseases.

Benefits to Dentists & Hygienists

  • Personalize your patient’s treatment and improve clinical decisions.
  • Improve your relationship with your patients and be an integral part of their health journey.

Benefits to the Practice

  • Use a cloud-based, no-cost, software solution with a frictionless workflow and complimentary education.
  • Increase patient retention and loyalty, monitoring oral and systemic health without taking up chair time.



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.

Noninvasive saliva collection | Mobile
This simple-to-use, at-home saliva collection kit includes everything your patient needs to collect and mail their saliva sample.

Comprehensive report with health | mobile
Your patient’s analysis will include six functional health scores and their CancerDetect results.


Reimbursable by medical | Mobile
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 Cancer Stect 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.



Early detection saves lives

CancerDetect


40%



The overall 5-year survival rate for people with late stage oral cancer is 40%3

84%



If diagnosed at an early stage, the overall 5-year survival rate is 84%4

28%



Unfortunately, with today’s practices, only 28% of patients are diagnosed at an early stage3



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 mobile

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™

Insight sample report mobile

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 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.

[Test] Sample Image 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.

[Test] Sample Image 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.

[Test] Sample Image 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.

[Test] Sample Image 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.

[Test] Sample Image 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. 



Oral Hygiene


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.


Nutritional Support


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. 



Professional Treatment


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?





Or email us for more information at OralCarePro@viome.com


hero

FDA breakthrough device
designation granted for accelerated review.

* This test is not an FDA-approved or cleared device

Our science sets mobile

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




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


  1. 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.

  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.