Startups on Fire — Firms more than five years old
Winner: Geneoscopy
Gastrointestinal health startup Geneoscopy is approaching a coveted milestone for any medical device firm: Commercialization.
Geneoscopy in May received U.S. Food and Drug Administration Approval for ColoSense, its at-home stool-based screening test for colon cancer. It plans to commercially launch ColoSense later this year or in early 2025. Geneoscopy has partnered with Burlington, North Carolina-based Labcorp (NYSE: LH) to distribute ColoSense to health care providers as part of their patient screening programs.
Founded in 2015, Geneoscopy has raised more than $100 million in financing as it's sought to bring its colorectal cancer screening test to market. Geneoscopy has 55 employees, with more than half of its workers based in St. Louis, where its headquarters is at 2220 Welsch Industrial Court.
Geneoscopy in June filed a counter suit in a competitor's claims of patent infringement. It has said it doesn't expect the legal dispute with Exact Sciences Corp., the Madison, Wisconsin, developer of the stool-based Cologuard colorectal cancer screening test, to affect its commercial launch.
What does the FDA approval mean for the company, and how will it enable its growth?
Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy. It demonstrates that our patented RNA technology can provide millions of eligible adults 45 years of age and older with a safe and effective option for detecting CRC and advanced adenomas. This milestone is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly yet preventable disease.
Designated as a "breakthrough device" by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to use RNA biomarkers to provide a dynamic view of disease activity. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.
FDA approval is a critical step in making ColoSense available to providers and patients. Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services.
How is being headquartered in St. Louis a competitive advantage for Geneoscopy?
Being headquartered in St. Louis offers Geneoscopy a distinct competitive advantage due to the city's robust entrepreneurial ecosystem. Over the past eight years, the financial support, mentoring, and infrastructure available here have been critical to our development and growth. This support was instrumental in catalyzing our Series B funding, conducting a pivotal clinical trial, and securing FDA approval for ColoSense. As we transition from FDA approval to the commercialization, the continued backing of St. Louis' entrepreneurial ecosystem remains a key factor in our success. The city's resources and community have been invaluable in helping us bring innovative healthcare technology to market, ultimately improving patient outcomes on a broader scale.
Geneoscopy has also said it plans to expand the scope beyond detecting colon cancer. How is the company going about this expansion?
Geneoscopy is developing diagnostic tests for other unmet needs in gastrointestinal health. Specifically, we are working on diagnostics tests for treatment selection and therapy monitoring in inflammatory bowel disease (IBD) in partnership with leading universities and biopharmaceutical companies. Our platform has demonstrated its unique capability to develop noninvasive and accurate tests for diseases of the gut, and we will continue to expand our scientific studies and clinical trials to ensure we are improving health for the 25% of Americans affected by gastrointestinal disease.
What was your company’s biggest achievement in the past year?
While we have had several notable achievements over the past year, the most significant milestone is the FDA approval of ColoSense. This has been pivotal in transforming Geneoscopy from a research and development company into a multifaceted organization poised for the commercialization of ColoSense.
Colorectal cancer (CRC) is the second deadliest cancer in the United States. While experts estimate that nearly 70% of all CRC deaths can be prevented through screening, millions of Americans are not getting screened because they lack access to or are averse to invasive procedures like colonoscopies. CRC incidence rates are also on the rise among younger populations with one in five new cases now occurring in individuals in their early 50s or younger. There is also a shift to later-stage disease, with more individuals now diagnosed at an advanced stage.
This shift prompted the United States Preventive Services Task Force to recommend the initiation of CRC screening at 45. Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. ColoSense has the potential to improve screening compliance and reduce morbidity and mortality associated with CRC.
Another major achievement is our collaboration with Labcorp, a global leader in innovative and comprehensive laboratory services. Labcorp, trusted daily by thousands of clinicians and millions of patients, presents an incredible opportunity to expand access to ColoSense. Through Labcorp’s extensive nationwide reach, this partnership will help reduce barriers to screening and address health inequities, making colorectal cancer detection more accessible to diverse communities.
What is your company’s top goal for the next year?
Geneoscopy’s top goals for the next 12 months are to complete a Series C financing and launch ColoSense. The Series C will provide the capital to scale operations in preparation for a commercial launch of ColoSense. Additionally, it will accelerate the company's research and development efforts. Geneoscopy is currently working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025.
See photos from the 2024 Fire Awards event below:
