Geneoscopy Prepares Launch of FDA-approved At-home RNA Colorectal Cancer Screening TestGeneoscopy Prepares Launch of FDA-approved At-home RNA Colorectal Cancer Screening Test

The St. Louis, MO-based company's test has 94% sensitivity for colorectal cancer detection. Colosense said it aims to transform gastrointestinal diagnostics, leveraging RNA technology for higher accuracy and ease of use.

Lisette Hilton, Reporter and President

January 21, 2025

5 Min Read
Medical illustration of Colorectal Cancer - Polyp
peterschreiber.media via iStock/Getty Images

At a Glance

  • Geneoscopy closed a $105 million Series C funding round to commercialize Colosense, an at-home colorectal cancer test.
  • The test faces challenges like securing Medicare coverage.
  • Geneoscopy’s innovative use of RNA could offer higher accuracy for conditions like inflammatory bowel disease.

Geneoscopy is poised to commercialize Colosense, its noninvasive, at-home multitarget stool RNA test for colorectal cancer screening.

In 2025, the St. Louis, MO-based life sciences company focused on developing diagnostic tests for gastrointestinal health, announced it closed $105 million in Series C funding, much of which the company will use to market Colosense, according to Geneoscopy CEO and Cofounder Andrew Barnell.

FDA approved Colosense for qualitative detection of colorectal neoplasia-associated RNA markers and the presence of occult hemoglobin in human stool. The prescription test is indicated for adults 45 years and older at average risk for developing colorectal cancer.

There are, however, still important hurdles to overcome before Geneoscopy becomes a covered and recommended option in patient care. One is to secure coverage for the screening, which starts with the Centers for Medicare and Medicaid Services (CMS). Geneoscopy expects CMS coverage in 2025, according to Barnell.

“CMS is always the first payor to cover a test,” Barnell told MD+DI.  

The United States Preventive Services Taskforce governs quality metrics for colorectal cancer screening. So, Geneoscopy is working on meeting requirements for quality metrics in order for Colosense, or a ribonucleic acid (RNA) stool-based test, to become part of evidence-based guideline recommendations. Guidelines currently include the fecal occult blood test, sigmoidoscopy, colonoscopy, virtual colonoscopy, and DNA stool test.

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The DNA stool test on the market is Cologuard, by Exact Sciences. (Editor’s note: Exact Sciences and Genescopy are squaring off in a patent infringement case.)  Similar to Colosense, Cologuard is indicated for adults 45 and older at average risk for colorectal cancer; patients administer the test at home and send in their stool samples; and it, too, aims to noninvasively screen for colorectal cancer and precancerous lesions.’

This is no easy task. Working with stool samples can be challenging, said Barnell.

“They are degraded with a lot of bacterial noise. They can be viewed as icky,” he said. “But when you think about gastrointestinal conditions, if you have inflammation or a precancerous adenoma or an adenocarcinoma the cell signals coming from those are confined to the gut.”

RNA Vs. DNA Is a Differentiator.

“RNA can be really informative. It’s phenotypic. It’s quantitative. You combine pulling RNA on stool samples and you have this tremendous platform to develop diagnostic tests for gastrointestinal conditions,” Barnell told MD+DI.

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RNA is not subject to age-related methylation patterns that can occur with DNA, he added.

The use of RNA in its screening tools allows Geneoscopy to potentially achieve higher accuracy when targeting conditions where DNA changes (mutations or methylation) aren't implicated.

“A great example is what we’re doing in inflammatory bowel disease where DNA changes aren't implicated …,” he said. “It’s an autoimmune inflammatory condition, so the use of RNA really opens up the possibility to develop diagnostic tests for the application. It really opens a lot of doors and is very different from what competitors are doing in the stool space.”

Another benefit of today’s Colosense technology is that it is transported entirely at ambient temperature.

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The Science

In a study of nearly 9,000 adults 45 and older, which compared the sensitivity and specificity of Colosense to colonoscopy, researchers reported the sensitivity of the multitarget stool RNA (mt-sRNA) test Colosense for detecting colorectal cancer was 94%. The sensitivity for detecting advanced adenomas was 46%. The specificity for no lesions on colonoscopy was 88%.

Authors of the same study, including Colosense cofounder Erica K. Barnell, MD, PhD., wrote that in patients 50 years and older, the mt-sDNA test Cologuard had a reported 92% sensitivity for colorectal cancer and 42% sensitivity for advanced adenomas. Additional Cologuard data for those ages 45 to 49 years showed 33% sensitivity for advanced adenomas, with no data on colorectal cancer sensitivity.

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Exact Sciences announced in October 2024 that FDA had approved its next-generation noninvasive multitarget stool DNA test Cologuard Plus. Results from BLUE-C study of about 20,000 patients at average risk compared the Cologuard Plus test to the fecal immunochemical test (FIT). According to the Exact Sciences-funded study published in the New England Journal of Medicine, “… we found that the next-generation multitarget stool DNA test showed 93.9% sensitivity for colorectal cancer, 43.4% sensitivity for advanced precancerous lesions, and 90.6% specificity for advanced neoplasia. This new version of the test was more sensitive than a commercial FIT for all screening-relevant lesions, but the FIT had higher specificity.”

Fueling the Future

There are seemingly endless ways in which innovators in the industry can improve the colorectal screening paradigm with increasing accuracy and sensitivity, ease of use, and other capabilities, according to Barnell.

“… it takes innovators like us. It takes new competitive technologies to get there,” Barnell said.

A key to success is developing a test that is intuitive and easy for patients to use.

“If there is one area where I think stool-based testing can continue to improve, it’s in making it easy for patients to do the test. We think we’ll have a number of additional announcements on that front as we move forward over the next couple of years,” he said.

All this isn’t cheap. Launching a diagnostic test like this--particularly one for the primary care market--is capital intensive.

Geneoscopy’s recent Series C included Bio-Rad Laboratories, which led the financing, and Petrichor, Labcorp, Morningside Ventures, Lightchain Capital, NT Investments, Granger Management and Mercy Health, Tri Locum Partners, and others.

“Today, we’ve raised over $150 million in capital,” he said.

Barnell said one of the things that excites him about the most recent funding round is the blend of different investor types. Those include a few financial investors, as well as two large strategics.

“We work on Bio-Rad’s digital PCR technology. We think it works really well for us, particularly working with RNA, to have a quantitative approach to measuring gene expression and building that into an algorithm,” Barnell said. “Labcorp is our commercial launch partner and will assist with detailing of the test, billing of the test, [educating physicians, and] making sure it’s easy for physicians to order.”

In addition to the commercialization of Colosense, a portion of the capital raised will fuel the company’s pipeline, according to Barnell.

“This is a platform technology. This isn’t just a company that does a colorectal screening test,” he said.

About the Author

Lisette Hilton

Reporter and President, Words Come Alive

Lisette Hilton loves covering medicine, health, wellness and fitness, and has been a reporter following her passion for more than 25 years.

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