AI Technology Platform With mRNA Analysis Designated as Breakthrough Device by FDA


For the detection of oral squamous cell carcinoma and oropharyngeal cancer, a novel technology has been granted breakthrough device designation by the FDA.

Breakthrough device designation from the FDA was granted to technology that combines mRNA analysis technology with artificial intelligence (AI) for the early detection of oral and throat cancers, according to the bioscience company responsible for developing the device, Viome.1

The propriety technology that is coupled with an AI platform may offer a novel method for detecting lesions normally discovered subjectively by clinicians through visual and tactile senses by way of saliva testing.

“Today’s standard of care to detect oral and throat cancer is severely outdated. Everyone relies on a primary care clinician to examine their mouths and look for lesions. This subjective and qualitative approach is a key reason why oral and throat cancer are detected at stage III or IV, when many people cannot receive life-saving treatments,” Naveen Jain, CEO, and Founder of Viome, said in a press release. “At Viome, we believe in the power of technology to help everyone stay healthier, do more, and live longer. This FDA approval of our technology and approach for early diagnosis of diseases when they are still treatable further cements our mission.”

The technology uses machine learning techniques to biomarkers in the progression of both oral squamous cell carcinoma and oropharyngeal cancer. The company has developed over 30 biomarkers for early cancer detection as well as other chronic disease and plans to gain similar designations from the FDA for technology related to their discovery.

In a study published in 2020 by Viome investigators, machine-learning classifiers using metatranscriptomic data from saliva samples of patients with premalignant disorders (n = 433) and oral cancer (n = 71) as well as healthy volunteers (n = 171). The technology yields a receiver operating curve area under the curve of 0.9 and sensitivity and specificity of 83% and 97.9%, respectively. Sensitivity for stage I cancers was 92.3%.2

This designation from the FDA is granted to products that offer more effective diagnosis or treatment of life-threatening or chronic disease, have no suitable alternative, provide greater advantages over the standard of care, and are in patients’ best interests.

According to Viome, this decision by the FDA validates its mRNA analysis technology, which it uses in other products, such as its Health Intelligence Test. The at-home test is for consumers who want the learn more about their gut microbiome, cellular, and immune system health as well as their stress responses and biological aging.


1. Viome Receives FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers. News release. Viome. May 6, 2021. Accessed May 6, 2021.

2. Banavar G, Ogundijo O, Toma R, et al. The salivary metatranscriptome as an accurate diagnostic indicator of oral cancer. Research Square. August 19, 2020. doi:10.21203/rs-55052/v1

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