Diagnostics startup Geneoscopy received its first FDA approval this week.
The St. Louis-based company received approval for ColoSense, its noninvasive colorectal cancer screening test. The test – which the FDA has called a breakthrough device – is approved for adults age 45 and older who are at average risk of developing colorectal cancer.
The approval marks only the second time the FDA has approved a molecular diagnostic test for colorectal cancer.
Geneoscopy was founded in 2015 by siblings Andrew and Erica Barnell. At this time, Andrew earned his MBA degree and Erica earned her MD/PhD degree.
“We decided to use the technology Erica developed during her doctoral work at WashU in St. Louis to isolate human RNA from stool samples. We thought this would be the perfect platform to develop diagnostic tests for gastrointestinal health,” Andrew, who serves as the company’s CEO, said in an interview.
In the past, colonoscopy was the gold standard for colorectal cancer screening tests, he said.
This invasive procedure involves inserting a flexible tube with a camera into a patient’s rectum to examine their colon. Not surprisingly, most patients dislike the procedure and find it extremely uncomfortable, Barnell noted.
Ten years ago, a non-invasive alternative emerged. Exact Sciences’ Cologuard, a test that screens for blood in stool, received FDA approval and was the first noninvasive colorectal cancer screening test to use DNA to detect disease. Now Geneoscopy’s ColoSense is the first device to use RNA biomarkers.
DNA methylation patterns can vary depending on a person’s age – RNA, on the other hand, is considered more dynamic and less susceptible to age-related fluctuations in methylation patterns, leading to more consistent test results.
ColoSense is a prescription test. When a doctor orders a test for their patient, Geneoscopy ships the test to the patient’s home. Once the patient provides a stool sample, they send the test back to Geneoscopy.
“Then we run our test, which combines RNA transcripts with a measurement of hemoglobin and a demographic and then generates a score. This value is either positive or negative and identifies people who may have colon cancer or precancerous adenomas. If a patient receives a positive result, our test indicates that they should be referred for a colonoscopy. And if that person comes back negative, they can continue with regular screening,” Barnell explained.
A clinical trial showed that the Geneoscopy test had a sensitivity rate of 93% for detecting colorectal cancer in average-risk patients.
Barnell said the company is currently in discussions with payers and expects to bring ColoSense to market later this year or early next year. Once Geneoscopy can secure payer agreements, he expects the test will soon save lives.
“Colon cancer is the second deadliest cancer worldwide and its incidence in the younger population has doubled in the last two decades. It is one of the most preventable diseases, but despite every effort over the last 20 years, 40% of people are not screened,” said Barnell. “When I think about the promise of a noninvasive test like ours for the 44 million Americans who are not up to date on early detection, I see an opportunity to address the screening paradigm – to get screened early and educate people .”
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