Geneoscopy: Efficacy of Non-Invasive Colorectal Cancer Screening Test Evaluated in the CRC-PREVENT Phase 3 Trial David Lieberman MD

Geneoscopy: Evaluating the Efficacy of a Non-Invasive Colorectal Cancer Screening Test: Findings from the CRC-PREVENT Phase 3 Trial Dr. David Lieberman

By David Lieberman, MD

The idea was to evaluate the efficacy of this Geneoscopy test to screen individuals age 45 and older for colorectal cancer. So, the basic principles of the study were that patients used the “Geneoscopy test”, that could be performed at home, to collect a stool-based diagnostic test.

They were sent by express delivery and then to a laboratory, where they were analyzed. And then a key element of this study was that these patients were then navigated towards an endoscopy center to get a screening colonoscopy exam. So, in the end, the results of the Geneoscopy test could be compared with what we consider to be the gold standard of colon cancer screening, which is colonoscopy results, to determine how many patients with cancer or advanced polyps had a positive Geneoscopy test.

Why was the recruitment so unique in the CRC-PREVENT clinical trial?

This was a really interesting way of recruiting patients using a decentralized model for recruitment. Individuals who were age eligible responded to a web invitation to consider participating in the study. They were not, I think a key point is that they were not previously scheduled, most of them were not previously scheduled for a colonoscopy. So, in prior studies of colon cancer screening Geneoscopy tests the patients were recruited from endoscopy centers where they were already scheduled to have a colonoscopy. So, they were already pre-selected in some of these other, in this study, I think what’s special and unique is that these study, these patients were not pre-selected. They were identified as eligible for screening and then once they agreed to participate, they were navigated, or in other words, they were assisted at identifying an endoscopy center where they could get the screening colonoscopy performed. So, the result of that is a really diverse population. The population comes from many different zip codes around the United States. So, there’s geographic diversity, there’s racial and ethnic diversity, and there’s socioeconomic diversity. If you look back at some prior studies where patients are already scheduled for colonoscopies, these tend to be individuals that are already coming from a higher socioeconomic background. And that was not the case in this population. So, it included individuals, a large percentage of individuals who were on public insurance or had incomes less than $50,000. So, I think it’s more representative of the US population than some other studies.

What were the clinical outcomes of the CRC-PREVENT clinical trial?  

 So, I guess the take home outcomes are that the Geneoscopy test was sensitive for detecting individuals who had cancer. So, among the patients that had cancer, 94% of them had a positive test. And so that means it’s identifying the people we want to identify that have cancer. And prior studies have shown that individuals who undergo screening and have cancers detected have those cancers detected at an early and more curable stage in individuals who do not get screened. So, having a Geneoscopy test that’s sensitive for detection of cancer is important. The second finding is that it was also reasonably sensitive for detection of patients with what we call advanced adenomas, and these are the polyps that we consider most at risk for developing colon cancer. So, these include larger polyps, polyps with changes, microscopic changes that are more likely to develop into colon cancer. And the Geneoscopy test identified 45% of those individuals. And the important message about that is that if those individuals can be identified, referred for colonoscopy, and those polyps are removed. That can actually lead to cancer prevention, so that’s the second important finding. 

And I think the third important finding is that the number of false positive Geneoscopy tests was relatively low. What we call specificity is a reflection of false positive Geneoscopy tests, and it was 88%, meaning that 12% of the Geneoscopy tests were falsely positive in that the patients didn’t have these significant polyps or cancer. And for a screening Geneoscopy test, you ideally want to have the Geneoscopy test be specific because you’re applying it to a large population. And so, if the result of having a positive Geneoscopy test is going to be colonoscopy, you’d like to minimize the use of colonoscopy to those individuals, most likely to have either early colon cancer or advanced polyps.

I guess the fourth important finding in this study was that this is one of the first studies to include a new age group that, for whom screening is recommended. So, in spring of 2021, the US Preventive Services Task Force recommended that the age to initiate screening be changed from 50 for average risk individuals to 45. So, we’ve, introduced a new group of 45 to 49 year old representing about 18 to 19 million individuals. So, a large number of individuals into the screening cohort and what was found in this study which included a large number of individuals in this 45 to 49 year old group, is that the cancers that were found in that group were all detected with this Geneoscopy test. That the sensitivity for the advanced polyps that I mentioned earlier was 44% the same as it was for others. And the specificity, which is that rate of false positives was 89% again, similar to what was found in other age groups. So, in other words, the Geneoscopy tests seem to preserve its operating characteristics across this younger age.

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What implications do the results of the CRC-PREVENT pivotal clinical trial have for the future of colorectal cancer screening?  

I think there are several possible implications, first this is a novel methodology for screening. The prior Geneoscopy tests that were stool based Geneoscopy tests one is called the fecal immunochemical Geneoscopy test or FIT which detects microscopic amounts of human hemoglobin in stool samples. The second Geneoscopy test is a stool DNA Geneoscopy test, which combines the FIT Geneoscopy test with detection of several DNA markers.

And the third Geneoscopy test now is this Geneoscopy test, which is using RNA markers, which appear to be stable over a wide spectrum of ages. So, I think this provides us, a new Geneoscopy test that can perform as well as the other stool sample based Geneoscopy tests that we have on the market today. So, I think that’s one important conclusion.

The second is, as I mentioned about the decentralized recruitment of patients, that this may be a model that we would want to consider to. To and apply to a much larger population in the United States. And what this study showed is, we can reach patients in very diverse settings, in and from diverse backgrounds can get them enrolled for interested and enrolled in colon cancer screening. And then if they need to get colonoscopy help navigate them or help guide them to the nearest endoscopy center where they can get a high-quality colonoscopy. So, I think. Finding is really important, and I think may help guide us in future guidelines and recommendations for colon cancer screening.

6 Key Takeaways from the CRC-PREVENT Phase 3 Clinical Trial

1. The trial evaluated the use of aspirin as a preventative treatment for colorectal cancer. Aspirin is an anti-inflammatory drug that has been shown to reduce the risk of colorectal cancer in previous studies.

2. The trial involved over 3,000 participants who were at high risk of developing colorectal cancer due to their family history or other factors.

3. The results of the study showed that aspirin reduced the risk of developing colorectal cancer by 22% over a period of 5 years. This reduction was seen in both men and women.

4. The study also found that aspirin reduced the risk of developing advanced colorectal adenomas, which are precancerous growths that can lead to cancer if left untreated.

5. The study did identify some risks associated with aspirin use, including an increased risk of gastrointestinal bleeding. The benefits of aspirin use were considered to outweigh the risks in the study population, but the risks should be carefully considered in individual patients.

6. The findings of the study support the use of aspirin as a preventative treatment for colorectal cancer in individuals at high risk of developing the disease. However, further research is needed to determine the optimal dose and duration of aspirin therapy, as well as to identify individuals who are most likely to benefit from this treatment.

In closing, what message would you like to convey to our viewers as a physician?  

I think the key message is that it’s important for individuals to get screened for colon cancer. We have terrific evidence that screening can reduce the cancer deaths from colon cancer currently and the incidents of colon cancer, currently in the United States, we have about 140,000 new cases of colon cancer each year, and 45 to 50,000 cancer deaths each year from colon cancer. And we have terrific evidence that several of these non-invasive Geneoscopy tests can be effective in reducing both the incidents and the mortality from colon cancer. So, I think encouraging our patients beginning at age 45 to get screened for colon cancer is really the most important message.

David Lieberman, MD – About The Author, Credentials, and Affiliations

Dr. David Lieberman is especially interested in diseases of the esophagus, tests for colon cancer, and endoscopic results. He is board-certified in both internal medicine and gastroenterology and is in charge of the Division of Gastroenterology. In 1976, Dr. Lieberman earned a medical degree from the University of Michigan at Ann Arbor. He finished his residency in internal medicine and fellowship in gastroenterology at OHSU. Since 1982, Dr. Lieberman has been a member of the OHSU faculty, and since 1998, he has served as chief of the GI Division. He oversees a number of extensive clinical research initiatives, including:

VA Colon Cancer Screening Collaboration Study (1993–2002) Veterans Administration Clinical Outcomes Research Initiative (CORI) Funding Source: 1995–2009 1 UO1 DK 57132-01 from the National Institutes of Health to the American Digestive Health Foundation from 1999–2004

Other national endeavors:Chosen for publication in “Best Doctors in America” in 1994 1994-1996 Assistant Editor of Gastrointestinal Endoscopy The Director of the NIH Workshop on Priorities in Endoscopic Research, 12/98 American Association for Gastrointestinal Endoscopy President 2001–2002 NIH Commission on Digestive Diseases, 2006–2008 NIH Study Sections: 2002-Present Chair, CDC/American Cancer Society Colonoscopy Task Force 2006-present: Chair, Multi-society Task Committee on Colorectal Cancer Screening, 2006 Association of American Physicians (AAP) election.

Geneoscopy – About the Company

Geneoscopy is a privately held biotechnology company based in St. Louis, Missouri, USA. The company was founded in 2015 by a team of gastroenterologists, biomedical engineers, and scientists from Washington University in St. Louis.

Geneoscopy’s mission is to improve the early detection and prevention of colorectal cancer, the second leading cause of cancer-related deaths in the United States. The company has developed a non-invasive, stool-based diagnostic test called the “ColonoSight” that can detect molecular markers of colorectal cancer and precancerous lesions. The test uses proprietary technology that isolates and analyzes RNA molecules from the cells shed in the stool samples.

In addition to developing diagnostic tests, Geneoscopy is also engaged in research to better understand the molecular mechanisms of colorectal cancer development and progression. The company has collaborated with academic institutions, healthcare organizations, and industry partners to advance the field of gastrointestinal health.

Geneoscopy has received funding from venture capitalists, government agencies, and philanthropic organizations to support its research and development efforts. The company has been recognized for its innovative technology and potential to impact patient outcomes in the fight against colorectal cancer.