Many hesitate to get screened for colorectal cancer, but future diagnostic tests now being developed could change that — and save lives.
Colorectal cancer is the second-leading cause of cancer death in the United States. The most common diagnostic screening for the disease is a colonoscopy. While colonoscopies are effective at detecting existing disease and identifying pre-cancerous polyps that need to be removed, less than 60 percent of eligible adults have undergone this life-saving procedure.
“Colonoscopies are invasive, expensive, and people don’t like the preparation required,” says Erica Barnell, Ph.D., chief science officer at Geneoscopy, a life sciences company that develops diagnostic tests for gastrointestinal health. “With the effects of COVID-19 and wider adoption of telemedicine, patients have increased desire for non-invasive tests that can be performed at home.”
Each year, 70 million Americans are affected by gastrointestinal diseases, including colorectal cancer. Geneoscopy’s goal is to improve the prevention, detection, and treatment of GI disease across this entire continuum.
An unmet need
Existing non-invasive colorectal cancer screening options are not very effective at preventing disease. “Existing non-invasive tests are quite good at identifying colorectal cancer but perform sub-optimally in identifying advanced adenomas (pre-cancerous polyps),” says George Catinis M.D., a gastroenterologist with Metropolitan Gastroenterology Associates in New Orleans and an investor in Geneoscopy. “Having a non-invasive test that helps identify the presence of advanced adenomas is what is really needed to significantly help prevent the development of colon cancer.”
Currently, there are a few non-invasive molecular diagnostic alternatives to colonoscopy, but they’re not very good at detecting precancerous lesions. Geneoscopy is developing a non-invasive molecular diagnostic that analyses the RNA in cells shed in stool to not only detect existing disease, but also aid in the prevention of future disease. “In a recently published study , the test demonstrated a 95 percent sensitivity in detecting colorectal cancer, and a 63 percent sensitivity in detecting advanced adenomas,” Dr. Barnell notes. “We showed a modest improvement in detecting colorectal cancer relative to existing non-invasive screening tools, and a significant improvement in advanced adenoma detection.”
Test sensitivity speaks to the false negative rate of a particular test. If a lesion with the potential to turn malignant is missed by a screening test, the gap between screenings — anywhere from 3-10 years — is more than enough time for that lesion to develop into cancer.
Geneoscopy’s future RNA-based screening test has been designed to address the problem. “What we’ve optimized is our sensitivity profile,” says Dr. Barnell. “We want future patients to be reassured that any test that comes back negative is really negative.”
Geneoscopy is dedicated to continuing research to expand the capabilities of its technology — and improve patients’ lives. It’s currently recruiting 10,000 people to participate in its CRC-PREVENT clinical trial designed to help it gain FDA approval for its colorectal cancer screening test. “We have a patient portal at ColonScreeningStudy.com where people can express interest in participating,” explains Barnell. “Through this portal, our nurses can identify and contact interested participants and remotely enroll them into the clinical trial.”
Once enrolled in the trial, a collection kit will be shipped to the participants’ home to be used at their convenience. They then ship the kit back using a pre-paid label and their sample will be analyzed in a centralized laboratory. The results will be compared to a colonoscopy to validate the accuracy and efficacy of the new screening technology.
As Dr. Catinis notes, that’s important for one simple reason — it will save lives. “Being able to identify and, ultimately, remove pre-cancerous polyps will reduce the incidence of cancer and the associated costs of treatment and mortality from the disease.”
Other potential benefits
Another promising dimension of Geneoscopy’s molecular diagnostic technology is its potential to look beyond cancer to assess a wide range of gastrointestinal diseases. Using RNA as a biomarker means the technology can serve as a platform to diagnose, select, and monitor therapies for other gastrointestinal conditions like inflammatory bowel disease (IBD). According to the CDC, an estimated 3 million US adults become diagnosed with IBD (either Crohn’s disease or ulcerative colitis) every year. Despite this, gastrointestinal diseases like IBD have been underserved by test developers and Geneoscopy’s technology holds the promise to help improve the management of these diseases.
To enroll in Geneoscopy’s CRC-PREVENT clinical trial, visit ColonScreeningStudy.com.