In a groundbreaking move to combat the rising incidence of colorectal cancer among younger adults, Viome Life Sciences and Scripps Research have announced a strategic partnership to develop the first at-home RNA test aimed at detecting precancerous colon polyps. This initiative, announced today, seeks to enable early prevention of colorectal cancer, a disease increasingly affecting adults in their 20s, 30s, and 40s.
The collaboration comes at a critical time, as colorectal cancer rates among younger populations surge, while screening participation remains low. By leveraging Viome’s advanced RNA sequencing and AI technology alongside the clinical expertise of Scripps Research and its Calibr-Skaggs Institute for Innovative Medicines, the partnership aims to launch a 1,000-patient observational clinical study this summer. The study will utilize RNA data from patients undergoing colonoscopies at Scripps Health to train Viome’s platform to detect early molecular signs of polyp development.
“Our partnership with Viome is about turning cutting-edge science into practical medical solutions,” stated Peter G. Schultz, Ph.D., President and CEO of Scripps Research. “This 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.”
The Growing Threat of Colorectal Cancer
Colorectal cancer has become the leading cause of cancer deaths in men under 50 and the second-leading cause in women under 50. Since the 1990s, the incidence in people under 50 has nearly doubled, with one in ten new diagnoses occurring in adults under this age. Projections indicate it may become the top cancer killer among young adults by 2030.
Naveen Jain, Founder and CEO of Viome, emphasized the importance of early detection. “Colorectal cancer is a preventable disease with early action,” he said. “This study is a critical first step toward developing an at-home RNA test that detects polyps before they turn cancerous, making screening simpler, affordable, and accessible.”
Challenges with Current Screening Methods
Despite guidelines recommending colonoscopies starting at age 45, nearly half of eligible adults skip screenings due to various barriers, including cost, lack of insurance, and the invasive nature of the procedure. Emotional apprehensions about potential diagnoses further deter participation, often leaving precancerous polyps undetected until they progress.
Current at-home stool DNA tests, while effective in detecting colorectal cancer with 95% sensitivity, only identify 43% of advanced precancerous polyps, limiting their preventive potential. Viome’s RNA-based approach aims to significantly enhance sensitivity for detecting precancerous polyps and colorectal cancer risk by analyzing dynamic microbiome and metatranscriptomic biomarkers, including immune responses.
Details of the Clinical Study
Scripps Research and Viome will conduct the observational clinical study with a cohort of 1,000 patients undergoing routine gastrointestinal exams. Using Viome’s RNA sequencing and AI platform, the study seeks to identify molecular signals years before standard screenings can detect them.
Amy Lightner, MD, the principal investigator of the study and a colorectal surgeon at Scripps Clinic, highlighted the study’s potential impact. “Colorectal cancer remains one of the deadliest diseases, with incidence rates climbing among younger generations. This new study has the potential to revolutionize how we detect and monitor colorectal cancer, particularly for at-risk individuals who may not be aware of their vulnerability,” she said.
Study Methodology
- 1,000 patients undergoing routine colonoscopies at Scripps Health
- Collection of Viome stool and saliva samples prior to the colonoscopy procedures
- Comparative analysis by Viome of gene expression profiles between patients with and without detected polyps
- Use of Viome’s AI platform to train predictive models on identifying early biomarkers
- Evaluation of the test’s sensitivity and specificity to ensure clinical reliability
Preliminary data from Viome already shows a metatranscriptomic signature capturing microbiome activity and human immune responses in the colon. If validated, Viome plans to develop a diagnostic test to identify individuals at high risk of polyps and cancer without requiring a colonoscopy.
Looking Ahead: Implications for Cancer Prevention
Initially, Viome will pursue a laboratory-developed test (LDT) for distribution through licensed physicians, allowing patients to collect samples at home. Upon study completion, Viome plans to publish the results and may seek FDA approval to establish the test as a standard of care for colorectal cancer prevention.
Viome’s current Full Body Intelligence™ Test already provides personalized health insights based on RNA activity. By expanding this capability, the partnership with Scripps Research aims to significantly advance colorectal cancer prevention, potentially reducing the disease’s impact on future generations.
