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

Download Mobile App

Next Gen Stool DNA Test Outperforms FIT in Colorectal Cancer Detection

By LabMedica International staff writers
Posted on 22 Mar 2024
Print article
Image: Cologuard Plus is the only noninvasive test to be evaluated head-to-head against an independent FIT (Photo courtesy of Exact Sciences)
Image: Cologuard Plus is the only noninvasive test to be evaluated head-to-head against an independent FIT (Photo courtesy of Exact Sciences)

A next generation multi-target stool DNA colorectal cancer (CRC) screening test has been found to have a detection rate of 94%, making it the most effective noninvasive screening test for identifying both CRC and advanced precancerous polyps.

Cologuard Plus, Exact Sciences Corp.’s (Madison, WI, USA) next-generation multi-target stool DNA test for CRC, features novel biomarkers and improved laboratory processes. In the 20,000-participant BLUE-C study, researchers determined the performance characteristics of Cologuard Plus and compared that performance to the fecal immunochemical test (FIT), a commonly used noninvasive CRC screening test. Both tests require a single stool sample analyzed in a lab, with FIT recommended yearly and stool DNA testing every three years. The study participants, asymptomatic men and women over 40, were a diverse population generally representative of racial and ethnic demographic characteristics of persons in the United States eligible for CRC screening.

In the study findings, Cologuard Plus surpassed FIT in cancer detection rates and showed greater sensitivity for advanced precancerous colon lesions, although FIT recorded a lower rate of false positives. With no polyps detected, both tests presented a 5% false positive rate. Cologuard Plus successfully met the study's goals, showcasing 94% sensitivity for CRC with 91% specificity when including non-advanced findings and 93% specificity excluding any findings. Notably, specificity increased to 96% among participants aged 45 to 54. Cologuard Plus can reduce the need for unnecessary follow-up colonoscopies by lowering the chances of a false-positive result. Exact Sciences submitted Cologuard Plus for U.S. Food and Drug Administration (FDA) approval in December 2023, with full BLUE-C results, and is gearing up for its launch in 2025, pending approval.

“We’re eager to bring an improved, noninvasive colorectal cancer screening test to patients in Cologuard Plus, as colorectal cancer remains the most preventable, yet least prevented cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences.

Related Links:
Exact Sciences Corp.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
Complement 3 (C3) Test
GPP-100 C3 Kit
Gold Member
Systemic Autoimmune Testing Assay
BioPlex 2200 ANA Screen with MDSS

Print article


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


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


view channel
Image: The groundbreaking treatment approach has shown promise in hard-to-treat cancers (Photo courtesy of 123RF)

Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment

Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read more


view channel
Image: Microscope image showing human colorectal cancer tumor with Fusobacterium nucleatum stained in a red-purple color (Photo courtesy of Fred Hutch Cancer Center)

Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.