Viome and Scripps Research Partner to Develop First At-home RNA Screening Test to Prevent Colon Cancer Before It Strikes

First-of-its-kind 1,000-patient clinical study will use RNA-based stool and saliva tests to detect colon polyps — early warning signs of colorectal cancer — before they become cancerous.

Study aims to enhance colorectal cancer prevention by identifying polyp molecular signals, offering improved sensitivity over at-home DNA tests, which have limited ability to detect precancerous lesions.

BELLEVUE, Wash. and LA JOLLA, Calif., July 14, 2025 /PRNewswire/ -- 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," said Peter G. Schultz, Ph.D., President and CEO of Scripps Research, and President of Calibr-Skaggs. "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 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 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

About Viome

Viome Life Sciences is a pioneering longevity and preventive healthcare company committed to bridging the gap between scientific breakthroughs and their practical implementation as health solutions. Utilizing cutting-edge AI and the world's largest gene expression database, Viome's home-based tests offer individuals personalized nutritional guidance and innovative microbiome health products to enhance lifespan and health.

Viome has empowered over half a million users with its unique approach that marries groundbreaking proprietary RNA sequencing methods with AI technology. This combination analyzes epigenetic biomarkers, providing robust, AI-driven health insights that contribute significantly to promoting a healthy lifespan.

With its top-tier precision nutrition recommendations, Viome offers a comprehensive and personalized solution to aging—at its optimum. This is more than just health optimization; it's a revolution in understanding how we age and enabling us to do so with vitality and wellness.

About Scripps Research

Scripps Research is globally recognized for the breadth and impact of its scientific contributions. Ranked by Nature Index among the world's top five most innovative institutes, Scripps empowers its scientists to pursue high-risk, high-reward ideas that transform our understanding of the world and lead to new technologies that shape our future. In addition to leading the way in curiosity-fueled science, Scripps Research is a world leader in translational research that accelerates the impact of fundamental research on human health.

Our translational research divisions, Calibr-Skaggs Institute for Innovative Medicines and the Scripps Research Translational Institute (SRTI), unique in the nonprofit research sector, are dedicated to turning scientific discoveries into real-world medical advances, including preventative approaches, diagnostics and new medicines.

Media Contacts:

Chris Hempel
Spark Public Relations for Viome
[email protected]
Scripps Research Office of Marketing & Communications
[email protected] 

SOURCE Viome Life Sciences