Multi-Cancer Detection Blood Test to Enable Early Diagnosis and Treatment
By LabMedica International staff writers Posted on 04 Jan 2023 |
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to a Multi-Cancer Detection Blood Test (MCDBT) that is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer.
In May 2022, Burning Rock Biotech Limited (Shanghai, China) had received CE mark for its OverC MCDBT manufactured in both its US and China facilities. Now, the FDA Breakthrough Device Designation granted for OverC MCDBT will pave the way for a clearer registration path through confirmative performance validation and utility establishment. Burning Rock’s OverC MCDBT demonstrated 69.1% sensitivity and 98.9% specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Test results of "Detected" with the top one or two predicted tissues of origin of cancer-associated signals may indicate the presence of cancer and should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines. Test results of "Undetected" do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests.
Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients' survival and quality of life while reducing social burden of the disease. Burning Rock had begun the development of multi-cancer early detection technology based on DNA methylation in 2016, and the technology and validation data have been presented at ASCO, ESMO and other medical conferences, as well as journals such as Nature Biomedical Engineering, demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin.
“We are very excited that our cfDNA methylation multi-cancer early detection technology has received FDA Breakthrough Device Designation. For cancer, early diagnosis and treatment are the key to the long-term survival of patients. Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now,” said Mr. Yusheng Han, founder and CEO of Burning Rock. “Burning Rock has also launched two prospectively collected case-control studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled, to continue developing OverC MCDBT to cover more cancer types. With our promising clinical research data, we believe that over time our collective effort is going to make significant impact towards the improvement of cancer patients' lifespan and quality of life.”
Related Links:
Burning Rock Biotech Limited
Latest Molecular Diagnostics News
- Blood Proteins Could Warn of Cancer Seven Years before Diagnosis
- New DNA Origami Technique to Advance Disease Diagnosis
- Ultrasound-Aided Blood Testing Detects Cancer Biomarkers from Cells
- New Respiratory Syndromic Testing Panel Provides Fast and Accurate Results
- New Synthetic Biomarker Technology Differentiates Between Prior Zika and Dengue Infections
- Novel Biomarkers to Improve Diagnosis of Renal Cell Carcinoma Subtypes
- RNA-Powered Molecular Test to Help Combat Early-Age Onset Colorectal Cancer
- Advanced Blood Test to Spot Alzheimer's Before Progression to Dementia
- Multi-Omic Noninvasive Urine-Based DNA Test to Improve Bladder Cancer Detection
- First of Its Kind NGS Assay for Precise Detection of BCR::ABL1 Fusion Gene to Enable Personalized Leukemia Treatment
- Urine Test to Revolutionize Lyme Disease Testing
- Simple Blood Test Could Enable First Quantitative Assessments for Future Cerebrovascular Disease
- New Genetic Testing Procedure Combined With Ultrasound Detects High Cardiovascular Risk
- Blood Samples Enhance B-Cell Lymphoma Diagnostics and Prognosis
- Blood Test Predicts Knee Osteoarthritis Eight Years Before Signs Appears On X-Rays
- Blood Test Accurately Predicts Lung Cancer Risk and Reduces Need for Scans