A new early-stage oral cancer detection test for dental professionals could offer an “unprecedented level of actionable insight into their patients' health,” according to the company launching it.
Viome Life Sciences has released the Oral Health Pro with CancerDetect, a device that, according to a company press release, uses proprietary RNA sequencing technology to measure gene expression of the oral microbiome and human cells in each patient’s saliva to identify early biomarkers associated with oral and throat cancer.
As such, “the 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,” said Guru Banavar, PhD, Viome’s founding chief technology officer, in the release. “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 device is not approved by the FDA but has received the agency’s Breakthrough Device Designation for accelerated review, a designation, according to the FDA, “intended to provide patients and health-care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.”
In 2022, Viome released an at-home test for oral and throat cancer intended for use by former or current tobacco users and anyone 50 years or older. That device, the CancerDetect Test for Oral & Throat Cancer, "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" with cancer-free specificity ≥ 95%, OSCC sensitivity ≥ 90%, and OPSCC sensitivity ≥ 90%, according to Viome’s website.
Sourced primarily from a press release dated September 28, 2023: Viome Launches Clinically Validated Oral Health and Early Stage Cancer Detection Test For Dental Professionals
