A collaboration between Viome Life Sciences and Scripps Research is set to develop and clinically validate the first ribonucleic acid聽(RNA) test aimed at detecting precancerous colon polyps.
This at-home test is designed to facilitate early prevention of colorectal cancer.
The partnership brings together Viome’s AI platform and RNA sequencing with the clinical expertise of Scripps Health, Scripps Research, and its discovery division, Calibr-Skaggs Institute for Innovative Medicines.
The team is set to start an observational clinical trial later this year involving 1,000 subjects. The trial will analyse RNA data gathered from those who are undergoing colonoscopies at Scripps Health for training Viome鈥檚 platform in identifying early molecular signs of polyp development before the emergence of cancer symptoms.
It includes the Viome stool and saliva sample collection before the procedures, and a comparative analysis of gene expression profiles.
Viome’s AI platform, adapted from its US Food and Drug Administration (FDA) breakthrough device-designated CancerDetect Oral & Throat test, will be used to train predictive models on detecting early microbiome and metatranscriptomic biomarkers.
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By GlobalDataPreliminary data from Viome have revealed a metatranscriptomic signature that captures both microbiome activity and human immune responses in the colon.
The upcoming study will validate these findings. If successful, Viome intends to develop a diagnostic test that utilises AI algorithms to detect those who are at elevated risk of polyps and cancer, negating the need for a colonoscopy.
Viome’s strategy includes initially pursuing a laboratory-developed test (LDT) to distribute via licensed physicians, enabling individuals to collect samples at home.
Following the study, the company plans to publish the outcomes and detected biomarkers to further colorectal cancer prevention efforts and may seek FDA clearance to establish the test as a standard in preventing this cancer.
Scripps Research CEO and president Peter Schultz said: 鈥淥ur partnership with Viome is about turning cutting-edge science into practical medical solutions.
鈥淭his study could deliver a simple, at-home RNA test that empowers people to detect cancer risk early, without invasive procedures, and take action before cancer takes hold.鈥�
