Viome Life Sciences, the leader in AI-powered, RNA-based diagnostics and precision nutrition and Scripps Research, the leader in accelerating the impact of fundamental research on human health, today announced a strategic partnership to develop and clinically validate the first at-home RNA test designed to detect precancerous colon polyps, enabling early prevention of colorectal cancer.
This strategic partnership comes amid a growing health crisis, as colorectal cancer is now striking adults in their 20s, 30s, and 40s at alarming rates, while screening rates remain low. By combining Viome's RNA sequencing and AI platform with the clinical and translational expertise of Scripps Research, its discovery division Calibr-Skaggs Institute for Innovative Medicines, and Scripps Health, the team is launching a 1,000-patient, observational clinical study starting this summer. The study will analyze RNA data collected from patients undergoing colonoscopies at Scripps Health to train Viome's platform to detect early molecular signs of polyp development before cancer symptoms emerge.
Our partnership with Viome is about turning cutting-edge science into practical medical solutions. 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."
Peter G. Schultz, Ph.D., President and CEO of Scripps Research, and President of Calibr-Skaggs
The most preventable deadly cancer is still rising
Colorectal cancer is now the leading cause of cancer deaths in men under 50 and the second-leading cause in women under 50. Rates in people under 50 have nearly doubled since the 1990s, with 1 in 10 new diagnoses occurring in adults under this age. By 2030, it is projected to become the top cancer killer of young adults.
"Colorectal cancer is a preventable disease with early action," said Naveen Jain, Founder and CEO of Viome. "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. We aim to shift from late-stage detection to true prevention, helping eliminate colorectal cancer from our future."
Why the current screening system isn't working
Despite guidelines recommending colonoscopies starting at age 45, nearly half of eligible adults skip screenings due to high costs, lack of insurance, fear of the invasive procedure, or time and discomfort involved. Emotional concerns about a potential diagnosis further deter participation, often leaving precancerous polyps undetected until they progress.
Current at-home stool DNA tests detect colorectal cancer (95% sensitivity) but identify only 43% of advanced precancerous polyps, limiting early prevention. Viome's RNA-based approach, using AI to analyze dynamic microbiome and metatranscriptomic biomarkers, including immune responses, aims to significantly enhance sensitivity for precancerous polyps and colorectal cancer risk, enhancing non-invasive screening.
How the study works
Scripps Research and Viome will conduct the observational clinical study in a cohort of healthy patients undergoing routine gastrointestinal exams. Leveraging Viome's RNA sequencing and AI platform, trained on the world's largest gene expression database, the test seeks to identify molecular signals years before standard screenings.
"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," said Amy Lightner, MD, the principal investigator of the study, as well as professor at Scripps Research and a colorectal surgeon at Scripps Clinic.
The study includes:
- 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, via unbiased RNA sequencing, between patients with and without detected polyps
- Use of Viome's AI platform, adapted from its FDA Breakthrough Device Designated CancerDetect™ Oral & Throat test, to train predictive models on identifying early microbiome and metatranscriptomic biomarkers, including microbial and human signals
- Evaluation of the test's sensitivity and specificity to ensure clinical reliability
Preliminary Viome data already shows a metatranscriptomic signature capturing both microbiome activity and human immune responses in the colon, which Viome aims to validate in the clinical study. If the study successfully validates microbiome and metatranscriptomic biomarkers associated with colon polyps, Viome plans to develop a diagnostic test using its advanced AI algorithms to identify individuals at high risk of polyps and developing cancer without requiring a colonoscopy.
Initially, Viome will pursue a laboratory-developed test (LDT) for distribution through licensed physicians, such as gastroenterologists, primary care providers or telemedicine practitioners, with patients able to collect samples at home. Upon completion, Viome plans to publish the study results, including the identified biomarkers, to advance colorectal cancer prevention, and may later seek FDA approval to establish the test as a standard of care for colorectal cancer prevention.
Viome's current Full Body Intelligence™ Test already offers powerful personalized health insights based on RNA activity. By analyzing samples from stool, saliva, and blood, the test delivers:
- Risk indicators for over 25 chronic conditions, such as type 2 diabetes, IBS, and metabolic disease
- Insights into biological aging and inflammation through InflammAging™ and BioAge™ scores
- Functional analysis of the gut and oral microbiome to support digestive and immune health
- Precision nutrition and supplement guidance to support longevity and reduce chronic inflammation
Exercise improves cancer outcomes by shaping the gut microbiome