Cancer test
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Advances in Multi-Cancer Detection Tests: A Comprehensive Overview
Introduction to Multi-Cancer Detection (MCED) Tests
Early detection of cancer significantly improves treatment outcomes and survival rates. Traditional screening methods, such as mammography and colonoscopy, are limited to specific cancer types. Recent advancements in multi-cancer early detection (MCED) tests, which utilize biomarkers like circulating tumor DNA (ctDNA) and protein markers, offer a promising alternative for detecting multiple cancer types through a single blood test .
CancerSEEK: A Pioneering Blood Test
Detection and Specificity
CancerSEEK is a noninvasive blood test designed to detect eight common cancer types by analyzing circulating protein biomarkers and tumor-specific mutations in cell-free DNA (cfDNA). In a study involving 1005 patients with nonmetastatic cancers and 850 healthy controls, CancerSEEK demonstrated a sensitivity range of 69% to 98% and a specificity of over 99%. This high specificity means that only a small fraction of healthy individuals received false-positive results, making CancerSEEK a reliable tool for early cancer detection.
Localization of Cancer
In addition to detecting cancer, CancerSEEK can localize the cancer to a small number of anatomic sites in 83% of patients, aiding in targeted diagnostic follow-ups and interventions.
Systematic Review of MCED Tests
A systematic review of cell-free nucleic acid-based MCED tests revealed that these tests generally exhibit high specificity (95% or higher) and a median sensitivity of 73% across various cancer types. Sensitivity tends to increase with the stage of cancer, highlighting the potential of these tests in early detection and diagnosis.
Feasibility Studies Combining Blood Tests and Imaging
Real-Time Trial with PET-CT
A large feasibility study involving 10,006 women without a history of cancer evaluated the integration of a multicancer blood test with positron emission tomography-computed tomography (PET-CT) imaging. The study detected 26 cancers, with 60% of those detected undergoing successful surgical removal. The combination of blood tests and PET-CT imaging improved the specificity and positive predictive value, demonstrating the potential for these tests to be safely incorporated into routine clinical care .
Performance in Symptomatic Individuals
A multi-cancer detection test using a targeted methylation assay and machine learning classifiers showed high specificity (99.5%) and moderate sensitivity (64.3%) in symptomatic individuals. The test was particularly effective in detecting gastrointestinal cancers, with a sensitivity of 84.1%. This suggests that the test could facilitate efficient diagnostic evaluations and stratify cancer risk in symptomatic patients.
Genomic Profiling and Clinical Validation
A clinical cancer genomic profiling test based on massively parallel DNA sequencing has been developed to identify various genetic alterations across 287 cancer-related genes. This test achieved a sensitivity of 95-99% and a positive predictive value of over 99%, revealing clinically actionable alterations in 76% of tumors tested. This comprehensive approach allows for personalized treatment plans based on the patient's molecular profile.
Conclusion
The development and validation of multi-cancer detection tests represent a significant advancement in the field of oncology. These tests offer high specificity and varying sensitivity across different cancer types and stages, providing a promising tool for early detection and improved treatment outcomes. Further studies and clinical trials are essential to establish the clinical utility, cost-effectiveness, and integration of these tests into routine healthcare practices.
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