#United States #Burlington #Labcorp #ColoSense #RNA Testing

Labcorp Launches ColoSense® Test for Colorectal Cancer

In an exciting development for colorectal cancer screening, Labcorp (NYSE: LH), a leader in laboratory services, has announced the nationwide availability of ColoSense®, the first and only RNA-based at-home test for detecting colorectal cancer approved by the U.S. Food and Drug Administration (FDA). This breakthrough test, developed in collaboration with Geneoscopy, aims to address the urgent need for accessible screening options for individuals at average risk of colorectal cancer.

Improving Access to Screening

Every year, millions of adults in the United States remain behind on recommended colorectal cancer screenings. The CDC reports that nearly 40% of eligible adults do not get the screening they need. While at-home tests provide a convenient alternative to traditional screenings, many people have hesitated to complete the process due to complexities in sample collection. Labcorp's research uncovered some significant hurdles: 41% of users felt uncomfortable with sample preparation, and 34% found the process messy. ColoSense® aims to simplify this experience.

Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp, stated, “Labcorp is committed to increasing colorectal cancer screening rates by providing at-home options that consumers are more likely to complete. With ColoSense available nationwide, we are expanding access to an FDA-approved screening option that employs advanced science and a streamlined collection process.”

How ColoSense® Works

ColoSense® employs cutting-edge RNA technology to identify biomarkers linked to colorectal cancer and advanced adenomas—precancerous growths indicating potential disease. This innovative test has been granted Breakthrough Device Designation by the FDA, highlighting its promise in effectively diagnosing serious health conditions. Furthermore, ColoSense aligns with the American Cancer Society and National Comprehensive Cancer Network screening guidelines, reinforcing its credibility among medical professionals.

“ColoSense reflects years of scientific innovation focused on enhancing how we screen for colorectal cancer at home,” remarked Matt Sargent, Chief Commercial Officer at Geneoscopy. This partnership with Labcorp aims to establish ColoSense as a fixture in routine healthcare, granting more patients access to life-saving early detection.

Effective Detection with Strong Performance

ColoSense® is designed for adults aged 45 to 85 who might be at average risk for colorectal cancer. The test has demonstrated impressive clinical performance, boasting a sensitivity of 93% for colorectal cancer among average-risk populations and an astounding 100% sensitivity for stage I colorectal cancer. Such precision ensures the earliest possible detection when treatment options are most viable.

Upon ordering the test, patients receive a collection kit sent directly to their homes. This kit features a user-friendly design that eliminates the need for separation or mixing of stool samples, aiming to make the process less daunting. Additionally, Geneoscopy provides patient navigation support to help individuals interpret their results and follow up with recommended actions, such as a diagnostic colonoscopy if necessary.

Conclusion: A Game Changer in Healthcare

The introduction of ColoSense® expands Labcorp's portfolio of colorectal cancer screening options significantly. This new at-home test not only enhances patient convenience but also promotes early detection, potentially saving countless lives. As healthcare continues to evolve, innovations like ColoSense are paving the way for more accessible, effective medical solutions.

For more details on ColoSense® and its availability, visit Labcorp's official site. Labcorp and Geneoscopy are dedicated to transforming colorectal health through innovative practices and empowering patients toward proactive health management.