Improved Colon Cancer Diagnosis with Multitargeted DNA Biomarker Test
|
By LabMedica International staff writers Posted on 31 Mar 2014 |
|
Image: Cologuard, a new colorectal cancer screening test in development, was able to detect 92% of colon cancers in a large clinical study (Photo courtesy of Exact Sciences).
A large-scale clinical study showed that a noninvasive test that detects several DNA biomarkers and blood in stool samples was significantly more sensitive than the currently used fecal immunochemical test (FIT) for diagnosis of colorectal cancer.
The Exact Sciences (Madison, WI, USA) Cologuard test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and beta-actin, plus a hemoglobin immunoassay. It was compared to a commercially available FIT assay and to the colonoscopy "gold standard" in a screen of nearly 10,000 patients.
Colonoscopy examinations of the 9,989 participants who could be evaluated detected 65 (0.7%) with colorectal cancer and 757 (7.6%) with advanced precancerous lesions. Comparing these results to the DNA assay and FIT revealed that the sensitivity for detecting colorectal cancer was 92.3% with DNA testing and 73.8% with FIT. The sensitivity for detecting advanced precancerous lesions was 42.4% with DNA testing and 23.8% with FIT. The rate of detection of polyps with high-grade dysplasia was 69.2% with DNA testing and 46.2% with FIT; the rates of detection of serrated sessile polyps measuring one centimeter or more were 42.4% and 5.1%, respectively. Specificities with DNA testing and FIT were 86.6% and 94.9%, respectively. Among participants with nonadvanced or negative findings on colonoscopy the results were 89.8% and 96.4%, respectively. Thus, while the DNA test was more sensitive than the FIT test, it did produce more false positive results, which would have led to unnecessary colonoscopies.
“Cologuard detection rates of early stage cancer and high-risk precancerous polyps validated in this large study were outstanding and have not been achieved by other noninvasive approaches,” said contributing author Dr. David Ahlquist, a gastroenterologist at the Mayo Clinic (Rochester, MN, USA) and co-inventor of the Cologuard test. “It is our hope that this accurate and user-friendly test will expand screening effectiveness and help curb colorectal cancer rates in much the same way as regular Pap smear screening has done for cervical cancer.”
The study was published in March 19, 2014, online edition of the New England Journal of Medicine.
Related Links:
Exact Sciences
Mayo Clinic
The Exact Sciences (Madison, WI, USA) Cologuard test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and beta-actin, plus a hemoglobin immunoassay. It was compared to a commercially available FIT assay and to the colonoscopy "gold standard" in a screen of nearly 10,000 patients.
Colonoscopy examinations of the 9,989 participants who could be evaluated detected 65 (0.7%) with colorectal cancer and 757 (7.6%) with advanced precancerous lesions. Comparing these results to the DNA assay and FIT revealed that the sensitivity for detecting colorectal cancer was 92.3% with DNA testing and 73.8% with FIT. The sensitivity for detecting advanced precancerous lesions was 42.4% with DNA testing and 23.8% with FIT. The rate of detection of polyps with high-grade dysplasia was 69.2% with DNA testing and 46.2% with FIT; the rates of detection of serrated sessile polyps measuring one centimeter or more were 42.4% and 5.1%, respectively. Specificities with DNA testing and FIT were 86.6% and 94.9%, respectively. Among participants with nonadvanced or negative findings on colonoscopy the results were 89.8% and 96.4%, respectively. Thus, while the DNA test was more sensitive than the FIT test, it did produce more false positive results, which would have led to unnecessary colonoscopies.
“Cologuard detection rates of early stage cancer and high-risk precancerous polyps validated in this large study were outstanding and have not been achieved by other noninvasive approaches,” said contributing author Dr. David Ahlquist, a gastroenterologist at the Mayo Clinic (Rochester, MN, USA) and co-inventor of the Cologuard test. “It is our hope that this accurate and user-friendly test will expand screening effectiveness and help curb colorectal cancer rates in much the same way as regular Pap smear screening has done for cervical cancer.”
The study was published in March 19, 2014, online edition of the New England Journal of Medicine.
Related Links:
Exact Sciences
Mayo Clinic
Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV
Latest Pathology News
- AI Integrated With Optical Imaging Technology Enables Rapid Intraoperative Diagnosis
- HPV Self-Collection Solution Improves Access to Cervical Cancer Testing
- Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues
- AI Advancements Enable Leap into 3D Pathology
- New Blood Test Device Modeled on Leeches to Help Diagnose Malaria
- Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing
- Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization
- First of Its Kind Universal Tool to Revolutionize Sample Collection for Diagnostic Tests
- AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis
- New Mycobacterium Tuberculosis Panel to Support Real-Time Surveillance and Combat Antimicrobial Resistance
- New Method Offers Sustainable Approach to Universal Metabolic Cancer Diagnosis
- Spatial Tissue Analysis Identifies Patterns Associated With Ovarian Cancer Relapse
- Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection
- Image-Based AI Shows Promise for Parasite Detection in Digitized Stool Samples
- Deep Learning Powered AI Algorithms Improve Skin Cancer Diagnostic Accuracy
- Microfluidic Device for Cancer Detection Precisely Separates Tumor Entities
Channels
Clinical Chemistry
view channel
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.jpg "Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)")
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
The conventional methods for measuring free cortisol, the body's stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting... Read more
Molecular Diagnostics
view channel
Blood Proteins Could Warn of Cancer Seven Years before Diagnosis
Two studies have identified proteins in the blood that could potentially alert individuals to the presence of cancer more than seven years before the disease is clinically diagnosed. Researchers found... Read more (1)_1.jpg "Image: Ultrasound image of micro-histotripsy liberation of biomarkers in a tumor (Photo courtesy of Joy Wang and Pradyumna Kedarisetti)"){kind=small}
Ultrasound-Aided Blood Testing Detects Cancer Biomarkers from Cells
Ultrasound imaging serves as a noninvasive method to locate and monitor cancerous tumors effectively. However, crucial details about the cancer, such as the specific types of cells and genetic mutations... Read more_1.jpg "Image: The innovative method to customize and strengthen DNA origami structure promises breakthroughs in medicine (Photo courtesy of Shutterstock)")
.jpg "Image: The QIAstat-Dx Respiratory Panel Plus has received U.S. FDA clearance (Photo courtesy of QIAGEN)")
Hematology
view channel
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
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West... Read more
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy
Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read moreImmunology
view channel.jpg "Image: The AI predictive model identifies the most potent cancer killing immune cells for use in immunotherapies (Photo courtesy of Shutterstock)")
AI Predicts Tumor-Killing Cells with High Accuracy
Cellular immunotherapy involves extracting immune cells from a patient's tumor, potentially enhancing their cancer-fighting capabilities through engineering, and then expanding and reintroducing them into the body.... Read more
Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
Transplanted organs constantly face the risk of being rejected by the recipient's immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute... Read more
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample.... Read more
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 moreMicrobiology
view channel
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
Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections
Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are... Read more
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases
GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name... Read more
Clinical Decision Support Software a Game-Changer in Antimicrobial Resistance Battle
Antimicrobial resistance (AMR) is a serious global public health concern that claims millions of lives every year. It primarily results from the inappropriate and excessive use of antibiotics, which reduces... Read moreTechnology
view channel
New Diagnostic System Achieves PCR Testing Accuracy
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex... Read more
DNA Biosensor Enables Early Diagnosis of Cervical Cancer
Molybdenum disulfide (MoS2), recognized for its potential to form two-dimensional nanosheets like graphene, is a material that's increasingly catching the eye of the scientific community.... Read more
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids.... Read more
Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible
Home testing gained significant importance during the COVID-19 pandemic, yet the availability of rapid tests is limited, and most of them can only drive one liquid across the strip, leading to continued... Read moreIndustry
view channel
Danaher and Johns Hopkins University Collaborate to Improve Neurological Diagnosis
Unlike severe traumatic brain injury (TBI), mild TBI often does not show clear correlations with abnormalities detected through head computed tomography (CT) scans. Consequently, there is a pressing need... Read more
Beckman Coulter and MeMed Expand Host Immune Response Diagnostics Partnership
Beckman Coulter Diagnostics (Brea, CA, USA) and MeMed BV (Haifa, Israel) have expanded their host immune response diagnostics partnership. Beckman Coulter is now an authorized distributor of the MeMed... Read more_1.jpg "Image: Thermo Fisher will distribute Bio-Techne products across Europe (Photo courtesy of 123RF)")
