FDA Approves ColoSense™ – Geneoscopy's Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test

Rhea-AI Summary

Geneoscopy, Inc. announces FDA approval for its noninvasive colorectal cancer screening test, ColoSense, with 93% sensitivity for detecting colorectal cancer and 45% sensitivity for detecting advanced adenomas in average-risk individuals. The breakthrough device provides a dynamic view of disease activity using RNA biomarkers, offering a promising tool for early-age onset CRC detection. The study showed 100% sensitivity for CRC in the 45-49 age group, a critical demographic, with a commercial launch planned in collaboration with Labcorp.

Positive

• FDA approval for ColoSense provides a safe and effective screening option for eligible adults, improving outcomes for colorectal cancer and advanced adenomas.

• ColoSense demonstrated 100% sensitivity for CRC in the 45-49 age group, highlighting its efficacy in early-age onset detection.

• The use of RNA biomarkers offers a dynamic view of disease activity, setting ColoSense apart as a breakthrough device for colorectal cancer screening.

• ColoSense detected 45% of advanced adenomas, emphasizing its role in preventing disease progression.

• Geneoscopy's decentralized enrollment approach in the CRC-PREVENT trial broadened participation and reached individuals not engaged in traditional healthcare screening programs.

Negative

• Colorectal cancer incidence rates are rising in younger populations under 50, posing a challenge for early detection and prevention.

• A significant percentage of eligible Americans ages 45-49 do not undergo screening, highlighting the need for innovative and accessible screening methods.

Insights

Medical Research Analyst

The FDA's approval of Geneoscopy's ColoSense as a noninvasive colorectal cancer (CRC) screening test carries significant implications for the future of cancer screening protocols and the broader healthcare sector. This test, which has demonstrated high sensitivity for detecting CRC, specifically 93% and 100% in certain age groups, represents a substantial advancement in early cancer detection. From the perspective of patient outcomes, the test's ability to detect CRC at stage I, where the disease is most curable, could potentially reduce mortality rates in the screened population. The adoption rate of ColoSense could be accelerated by its noninvasive nature, potentially addressing the current screening gap caused by the reluctance towards more invasive procedures like colonoscopies. Furthermore, the test's reliance on RNA biomarkers may offer more consistent performance across different age demographics, which is important given the observed rise in CRC incidence among younger adults. It's also noteworthy that the test detected a lower, but still significant, rate of advanced adenomas, which are precursors to CRC. The commercial launch of ColoSense, in collaboration with Labcorp, could see Geneoscopy tapping into established distribution networks, likely smoothing the path for market penetration. However, the test's long-term success will hinge on the receptiveness of payors and the integration within existing screening guidelines.

Healthcare Market Analyst

The market impact of the newly FDA-approved ColoSense test extends beyond Geneoscopy as a company. This approval could shift the dynamics of the CRC screening market, which has been traditionally dominated by colonoscopy procedures. By offering a noninvasive and potentially more accessible screening option, Geneoscopy could capitalize on a significant portion of the approximately 40% unscreened eligible Americans in the 45-49 age range. The Breakthrough Device designation by the FDA indicates that ColoSense is expected to provide more effective treatment or diagnosis of life-threatening diseases, which may facilitate a smoother path to insurance coverage and clinical adoption. As a partnership with Labcorp is already in place, the test could swiftly reach a wide customer base, creating a strong potential for commercial success. It’s important to monitor the response of the healthcare system, particularly insurance companies and professional societies, to the introduction of ColoSense. Their support and advocacy will be critical in determining the test's reimbursement landscape and ultimately its market penetration. From an investor's standpoint, entry into this fast-evolving segment of the healthcare market could spell long-term growth, provided that subsequent post-market surveillance continues to support the test's safety and efficacy profiles.

• In average-risk individuals, ColoSense demonstrated 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas (AA).
• The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC.

ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.

Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.^1-2

“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement 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.”

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force's guidelines to recommend initiation of CRC screening at age 45.³ 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 50.⁴ Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.^5,6

“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It's essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC. “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”

FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services.

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References:

1. Ahlquist DA, Taylor WR, Yab TC, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572-3572. https://doi.org/10.1158/1538-7445.am2012-3572
2. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133
3. Mehta SJ, Morris AM, Kupfer SS. Colorectal Cancer Screening Starting at Age 45 Years—Ensuring Benefits Are Realized by All. JAMA Netw Open. 2021;4(5):e2112593. doi:10.1001/jamanetworkopen.2021.12593
4. American Cancer Society https://pressroom.cancer.org/acs-cff-2024
5. Hyams T, Mueller N, Curbow B, King-Marshall E, Sultan S. Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translational Behavioral Medicine. 2022;12(2):198–202. https://doi.org/10.1093/tbm/ibab079
6. US Census data, Geneoscopy estimates (includes US markets only)

 

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Media

Andrea Sampson

Sampson Public Relations Group

asampson@sampsonprgroup.com

Investor Relations

Carrie Mendivil / Ji-Yon Yi

Gilmartin Group

investors@geneoscopy.com

Source: Geneoscopy, Inc.

FAQ

What is the sensitivity of ColoSense for detecting colorectal cancer?

ColoSense demonstrated 93% sensitivity for detecting colorectal cancer in average-risk individuals.

What is the sensitivity of ColoSense for detecting advanced adenomas?

ColoSense showed 45% sensitivity for detecting advanced adenomas in average-risk individuals.

What age group was evaluated in the CRC-PREVENT study for ColoSense?

The CRC-PREVENT study evaluated individuals aged 45-49 for ColoSense.

What did the study report regarding CRC and AA sensitivity in the 45-49 age group?

The study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49.

Who is Geneoscopy collaborating with for the commercial launch of ColoSense?

Geneoscopy is collaborating with Labcorp (NYSE: LH) for the commercial launch of ColoSense.