We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
RANDOX LABORATORIES

Download Mobile App




RNA-Powered Molecular Test to Help Combat Early-Age Onset Colorectal Cancer

By LabMedica International staff writers
Posted on 10 May 2024
Print article
Image: ColoSense is the first FDA-approved RNA-based molecular screening test for qualitative detection of colorectal cancer (Photo courtesy of Geneoscopy)
Image: ColoSense is the first FDA-approved RNA-based molecular screening test for qualitative detection of colorectal cancer (Photo courtesy of Geneoscopy)

Colorectal cancer (CRC) ranks as the second most lethal cancer in the United States. Nevertheless, many Americans eligible for screening do not undergo testing due to limited access or reluctance towards invasive methods like colonoscopies. Additionally, rising CRC incidence rates among individuals under 50 have led the United States Preventive Services Task Force to lower the recommended screening age to 45. Highlighting the severity of this issue, the American Cancer Society has recently declared CRC as the leading cause of cancer-related deaths among men and the second-leading cause among women under 50. This issue is further exacerbated by the fact that about 40% of those who are unscreened and eligible are between the ages of 45 and 49. Now, the U.S. Food and Drug Administration (FDA) has approved a noninvasive CRC screening test for adults, 45 years of age or older, who are at typical average risk for developing the disease.

Geneoscopy, Inc.’s (St, Louis, MO, USA) ColoSense, designated as a Breakthrough Device by the FDA, is the first noninvasive CRC screening test to provide a dynamic view of disease activity by utilizing RNA biomarkers. RNA biomarkers are advantageous as they are not influenced by age-related methylation patterns, which can affect test performance across different age groups. In order to evaluate ColoSense, the CRC-PREVENT trial by Geneoscopy assessed individuals aged 45 and older from diverse racial, ethnic, and socioeconomic backgrounds, employing a decentralized enrollment strategy. Remarkably, 64% of participants had never been screened for CRC, and 68% had not planned a colonoscopy at enrollment, differing from traditional trials that usually involve participants already engaged in health screening programs.

ColoSense demonstrated a 93% sensitivity rate for detecting CRC and importantly, identified all stage I CRC cases, where the disease is most treatable. It also detected 45% of advanced adenomas, which are more preventable stages of the disease. The study also found that the test achieved 100% sensitivity for CRC and 44% sensitivity for advanced adenomas among participants aged 45-49, emphasizing the importance of this screening age group. The FDA’s approval of ColoSense marks a significant advancement in making this vital screening tool accessible to patients. Geneoscopy is planning a commercial launch later this year or early in 2025 to ensure timely access to ColoSense for supporting CRC screening efforts.

“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.”

Related Links:
Geneoscopy, Inc.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
MAG and HEATMAG
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
New
Gold Member
Hemoglobin Testing System
VARIANTnbs

Print article

Channels

Clinical Chemistry

view channel
Image: The 3D printed miniature ionizer is a key component of a mass spectrometer (Photo courtesy of MIT)

3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more

Hematology

view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more

Immunology

view channel
Image: The novel test uses an existing diagnostic procedure as its basis to target the Epstein Barr Virus (Photo courtesy of 123RF)

Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability... Read more

Microbiology

view channel
Image: The T-SPOT.TB test is now paired with the Auto-Pure 2400 liquid handling platform for accurate TB testing (Photo courtesy of Shutterstock)

Integrated Solution Ushers New Era of Automated Tuberculosis Testing

Tuberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed... Read more

Pathology

view channel
Image: Insulin proteins clumping together (Photo courtesy of Jacob Kæstel-Hansen)

AI Tool Detects Tiny Protein Clumps in Microscopy Images in Real-Time

Over 55 million individuals worldwide suffer from dementia-related diseases like Alzheimer's and Parkinson's. These conditions are caused by the clumping together of the smallest building blocks in the... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.