Health Tech

FDA Grants First-Ever Approval to an RNA-Based Diagnostic for Colorectal Cancer

Geneoscopy received approval for its noninvasive colorectal cancer screening test, which the FDA designated as a breakthrough device. This marks only the second time the FDA has issued an approval for a molecular diagnostic test for colorectal cancer — and the first time the agency has done so for a colorectal cancer test that uses RNA.

Diagnostics startup Geneoscopy earned its first-ever FDA approval this week. 

The St. Louis-based company received approval for ColoSense, its noninvasive colorectal cancer screening test. The test — which the FDA designated as a breakthrough device — is approved for adults ages 45 and older who are at average risk for developing colorectal cancer.

The approval marks only the second time the FDA has issued an approval for a molecular diagnostic test for colorectal cancer.

Geneoscopy was founded in 2015 by a pair of siblings, Andrew and Erica Barnell. At the time, Andrew was earning his MBA degree and Erica was earning her MD/PhD degree.

“We decided to leverage technology that Erica developed while she was getting her PhD at WashU in St. Louis to isolate human RNA from stool samples. We thought that was the perfect platform to develop diagnostic tests for gastrointestinal health,” Andrew, who serves as the company’s CEO, explained in an interview.

Historically, colonoscopy has been the gold standard for colorectal cancer screening tests, he said.

During this invasive procedure, a flexible tube with a camera is inserted into a patient’s rectum to examine their colon. Unsurprisingly, most patients don’t like the procedure, finding it highly uncomfortable, Barnell noted.

Ten years ago, a noninvasive alternative emerged. Exact Sciences’ Cologuard, a test that screens for blood in the stool, received FDA approval and became the first noninvasive colorectal cancer screening test that uses DNA to detect disease. Now, Geneoscopy’s ColoSense has become the first one that uses RNA biomarkers.

DNA methylation patterns can vary depending on a person’s age — whereas RNA is considered more dynamic and less prone to age-related variability in methylation patterns, leading to more consistent test results.

ColoSense is a prescription-only test. When a physician orders one for their patient, Geneoscopy ships the test to the patient’s home. Once the patient deposits a stool sample, they ship the test back to Geneoscopy. 

“Then we run our test, which combines RNA transcripts with a measurement of hemoglobin and one demographic feature and then generates a score. That score is either positive or negative, identifying folks who potentially have colorectal cancer or precancerous adenomas. If a patient receives a positive, our test will indicate that they should be navigated onto a colonoscopy. And if that person is negative, then they can continue with regular screening,” Barnell explained.

A clinical trial showed that the Geneoscopy’s test had a 93% sensitivity rate for colorectal cancer detection in patients with average risk.

Barnell said that the company is currently in discussions with payers, expecting to commercialize ColoSense later this year or early next year. Once Geneoscopy can secure payer agreements, he expects that the test will quickly begin saving lives.

“Colorectal cancer is the second deadliest cancer worldwide, and its incidence in the younger population has doubled over the past two decades. It’s one of the most preventable diseases, but despite all the efforts for the last 20 years, 40% of people don’t get screened,” Barnell declared. “When I think about the promise of a noninvasive test like ours for the 44 million Americans who aren’t up to date with screening, I see an opportunity to engage with the screening paradigm — to get screened early and educate folks.”

Photo: marchmeena29, Getty Images