By Kathleen Berger, Executive Producer for Science & Technology
“We call it the ‘ick factor’. We try to mitigate the ‘ick factor’ as much as possible,” said Erica Barnell, PhD, co-founder and chief science officer for Geneoscopy, a life sciences startup company. “I think people are becoming a little bit more used to it. “
Erica Barnell knows she has to help people get past that part of her work. It’s the part that involves stool samples collected at home and sent to her lab at St. Louis-based Geneoscopy, located in Maryland Heights. Over the last few years, Barnell developed the focus and drive to try to prevent colorectal cancer, the second most common cause of cancer death in the United States.
“Such a preventable disease,” she explained. “If you catch it early, you have unbelievable prognosis, great survival. It’s indolent so it develops over the course of a number of years, starting as normal tissue and then advancing to a polyp and then becoming malignant. So it provides individuals with the opportunity to catch it early. “
Stool samples are becoming part of the solution. Barnell said catching colorectal cancer early doesn’t happen unless people are having colonoscopies as recommended.
“We’re really bad at diagnosing colorectal cancer in early stage because of the existing methodologies to detect colorectal cancer,” said Barnell. “Traditionally we’ve been using colonoscopies but patients are very adverse to that procedure because it’s invasive, time consuming and expensive. Our approach is to develop noninvasive molecular diagnostics that can accurately detect both colorectal cancer and precancerous lesions to help improve compliance with colorectal cancer screening and reduce morbidity and mortality associated with the disease.”
Geneoscopy is developing noninvasive ways to monitor, diagnose and treat gastrointestinal disease. The company’s innovative RNA-FIT stool test is priority.
“The diagnostic is both a fecal immunochemical test which detects if there’s blood present in your stool sample. And in combination we supplement that diagnostic with an RNA-based panel. The RNA panel specifically detects advanced adenomas, which are very large polyps that have a high malignant transformation rate. So the RNA-FIT, in combination, both detects and prevents cancer through cancer detection and precancerous lesion detection.”
Genepscopy’s laboratory is processing samples for its clinical trial.
“Our tests would be recommended for anyone between 45 and 75 who is average risk for colorectal cancer screening,” explained Barnell. “You enroll online so we have a site where patients can go and enroll and ultimately can get a diagnostic prescribed to them. The first step is we send a kit to the patient’s home. If the result is positive, we recommend the patient go receive a colonoscopy to potentially remove lesions that we detected noninvasively. If the result is negative, the patient is cleared and considered eligible for their next recommended screening interval, which will be in about three years.”
Barnell encourages participation in the trial based on early stage clinical trial results.
“In our recent clinical trial, the sensitivity for cancer was 95% and the sensitivity for advanced adenomas with 60%.”
Barnell said this is a significant advancement in accuracy of adenoma sensitivity over other noninvasive testing by 50%.
The American Cancer Society recommends that people with average risk of colorectal cancer start regular screenings at the age of 45 rather than the age of 50. This is because studies show rates of colorectal cancer among people younger than 50 are on the rise.
“You can imagine if a patient turns 50 and they’ve had a lesion in their colon that’s been growing for the last three or four years, if they get a colonoscopy right at 50 that lesion is detected and the lesion is removed. The patient is fine,” she explained. “If that lesion continues to grow and say you keep putting off your colonoscopy and now you’re 51, now you’re 52, now you’re 53, the pandemic hits and you don’t want to go get the colonoscopy, so now you’re 54. That lesion has been growing now for six or seven years. And if it turns into something malignant, you can develop symptoms that are not asymptomatic. You start having problems with your bowel movements. You start developing symptoms that are a response to the carcinoma. And so you go to the doctor because those symptoms are concerning and at that point you detect a cancer that has advanced, that would have been detected and removed at an earlier stage had you gone and received the colonoscopy at 50.”
While Barnell said a colonoscopy is very important, she hopes Geneoscopy will improve widespread disease detection and prevention.
“A colonoscopy serves as both the method for diagnosis as well as the method for treatment. You can remove those lesions during the colonoscopy procedure. However, the backlog for the number of colonoscopies that need to be done is huge. My goal, instead of replacing colonoscopies, is to identify the individuals that need a colonoscopy. Identify individuals that have lesions that need to be removed and put those individuals to the top of the list so that they can get the procedure early, get the lesions removed and not have to go through an unnecessary colonoscopy when they’re mucosa is fine.”