Gut microbiome health firm Viome has repurposed its mRNA analysis and machine learning technologies to develop a saliva test to monitor for head and neck cancers. Viome’s diagnostic test, which obtained Breakthrough Device designation in the US Food and Drug Administration (FDA) in May, is based on results from a research combining microbial RNA (the metatranscriptome) in saliva using next-generation sequencing with machine learning to identify biomarkers linked to oral cancers. The algorithm seen early signs of oral cancer using a 83% sensitivity and a specificity of almost 98%. The risk of oral cancer increases in people over 50 or with a history of smoking or excessive alcohol consumption, and multiple studies in the past decade have demonstrated associations between changes in the oral microbiome and cancer. To develop a diagnostic tool, scientists in the Viome Research Institute, the organization’s research arm, used microbiome transcriptome profiling to research the saliva microbiome from 71 patients with diagnosed oral premalignant conditions or cancer and 171 healthy controls. MRNA sequencing offers an indication of the genes that are expressed within a community, focusing on bacterial purpose and action (rather than metagenomics as assessed by 16S ribosomal RNA or DNA). One finding is that high levels of transcripts from periodontal bacteria Fusobacterium, Prevotella and Prophyromonas in saliva samples and another eight parasitic species involved in biofilm formation are associated with tumorigenesis. Each year, 350,000400,000 patients worldwide are newly diagnosed with oral cancers. Without a early detection instruments, diagnosis is chiefly at late phases, and as a result, the five-year survival has stayed at 40percent for four decades. But prior to the parasitic metatranscriptome can serve as an accurate, noninvasive diagnostic to prevent oral cancers, potential studies in well-characterized patient groups will be critical. Viome has yet to receive FDA approval for the oral cancer evaluation.
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