Viome Life Sciences is officially launching Oral Health Pro with CancerDetect™, a new test designed to help clinicians provide their patients with oral health insights and early-stage cancer detection.
Viome Life Sciences recently unveiled Oral Health Pro with CancerDetect, an innovative test designed to provide dental professionals with actionable insights into their patients' health, including early detection of biomarkers associated with oral and throat cancer.
The test has achieved an specificity of 95 percent and sensitivity of 90 percent, backed by clinical validation data recently published in the article “Detecting salivary host and microbiome RNA signature for aiding diagnosis of oral and throat cancer” which was published in the October 2023 issue of Oral Oncology Journal.
“Viome’s holistic and scientific approach to health will transform how people approach oral hygiene and care,” Viome’s Chief Dental Officer Ed Zuckerberg, DDS, FAGD, says in a press release. “The Oral Health Pro test is ushering in a new era of preventative care that benefits patients and dental professionals. The current standard of oral care is extremely outdated, relying heavily on visual and tactile examinations. Viome is setting a new standard that uncovers the intricate interplay between microbial activities and human gene expression in the development of oral diseases and cancers.”
The Oral Health Pro with CancerDetect test uses Viome’s proprietary RNA sequencing technology and artificial intelligence to measure gene expression of the oral microbiome and human cells in a patient's saliva. This identifies early biomarkers associated with oral and throat cancer. The test has received an FDA Breakthrough Device Designation for accelerated review due to its potential transformative impact on early cancer detection.
Along with the detection of cancer-associated biomarkers, the Oral Health Pro also identifies biomarkers linked to poor gum health, cavities, bad breath, pathobiont activity, fungal activity, and genotoxic activity. Many of these biomarkers are also associated with systemic health risks.
The test requires a saliva sample which can be collected in a dental practice, but can just as easily be collected by the patient at home. The test results can then be used by dentists to guide clinical decision-making and develop personalized treatment plans.
“Viome’s unique technology can see a lot deeper than other tests since we detect the gene expression activity of a wide range of microbial as well as human cells,” says Guru Banavar PhD, Viome’s founding chief technology officer. “We further quantify the molecular pathways associated with oral health issues by applying machine learning on a very large dataset, trillions of nucleotides derived from tens of thousands of saliva samples. These analyses are translated into a simple report that helps dental professionals and patients understand their oral and systemic health risks.”
The clinical validation study of the biomarker for oral and throat cancer involved 1175 individuals and included collaboration with renowned salivary researcher Professor Chamindie Punyadeera, PhD, of Griffith University, Salomon Amar, DDS, PhD, of New York Medical College, and other experts across multiple clinical centers.
“This test represents a novel use of saliva for assays aimed at the improvement in test characteristics of oral cancer screening tools, along with being user-friendly,” says Dr Amar.
Oral Health Pro test results are available through a cloud-based, no-cost software solution with a seamless workflow that can be easily integrated into a dental practice. The test can help with monitoring oral and systemic health of patients without consuming chair time.