By Mridula George, MD
Breast cancer is a complex disease that requires a timely and accurate diagnosis, appropriate treatment, and close monitoring of disease progression. Despite the advances in diagnostic and treatment modalities, disease recurrence and progression remain a significant concern for breast cancer patients. Therefore, identifying reliable biomarkers that can predict disease recurrence and monitor disease progression is crucial for improving patient outcomes.
Cell-free circulating tumor DNA (ctDNA) has emerged as a promising biomarker in breast cancer. ctDNA is released into the bloodstream by tumor cells and can be detected and quantified using highly sensitive techniques such as the Natera Signatera assay. The detection of ctDNA in the blood of breast cancer patients has been found to be a strong predictor of disease recurrence, even in patients who have undergone adjuvant therapy.
The Natera Signatera assay is a highly sensitive and specific technique for the detection and quantification of ctDNA (circulating tumor DNA) in breast cancer patients. The assay uses a targeted next-generation sequencing approach to detect mutations in genes that are commonly mutated in breast cancer. The assay can detect ctDNA at a level as low as 0.01% of the total DNA in the sample.
Several studies have investigated the role of ctDNA in predicting disease recurrence in breast cancer patients using the Natera Signatera assay. In a study of 217 patients with early-stage breast cancer, the assay was able to predict disease recurrence with a sensitivity of 89% and a specificity of 94%. Furthermore, the assay was able to detect ctDNA up to 11 months before clinical recurrence was observed.
The early detection of ctDNA (circulating tumor DNA) using the Natera Signatera assay may allow for early intervention and delay the progression to metastatic disease. For example, in a study of 56 patients with metastatic breast cancer, the assay was able to detect ctDNA in 93% of patients, with a median lead time of 5.9 months before radiographic progression was observed. The early detection of ctDNA allowed for the initiation of targeted therapy in these patients, resulting in a delay in disease progression and improved survival outcomes.
In addition to predicting disease recurrence and monitoring disease progression, the Natera Signatera assay can also be used to monitor treatment response in breast cancer patients. For example, in a study of 24 patients with HER2-positive breast cancer, the assay was able to detect a decrease in ctDNA levels in response to HER2-targeted therapy. Furthermore, the decrease in ctDNA (circulating tumor DNA) levels was predictive of progression-free survival.
In conclusion, the Natera Signatera assay is a highly sensitive and specific technique for the detection and quantification of ctDNA in breast cancer patients. The detection of ctDNA using this assay is a strong predictor of disease recurrence and progression, and may allow for early intervention and delay in disease progression. Additionally, the assay can be used to monitor treatment response in breast cancer patients, providing valuable information for clinical decision-making.
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Circulating tumor DNA (ctDNA) is a valuable tool for cancer diagnosis, treatment, and monitoring, as it contains genetic mutations specific to the tumor (cells (cell-free dna)) it originated from.
Natera is a company that offers ctDNA analysis services through their proprietary technology called Signatera.
Signatera is designed to detect ctDNA in blood sample (s) and monitor treatment response and cancer recurrence in patients with solid tumors.
Signatera has shown high sensitivity and specificity in detecting ctDNA in various cancer types, including lung cancer, colorectal cancer, breast cancer, and bladder cancer.
Signatera has also demonstrated clinical utility in detecting ctDNA (circulating tumor DNA) through ctDNA testing (tumor DNA detection), to help predict treatment response and monitoring disease progression in patients with advanced cancer.
Signatera can be used as a complementary tool to standard imaging and biopsy methods (e.g. liquid biopsy or liquid biopsy and other procedures), providing additional information about tumor burden and treatment efficacy.
Natera offers Signatera as a laboratory-developed test (LDT) that is performed in their CLIA-certified and CAP-accredited laboratory.
Signatera can be customized for each patient based on their tumor-specific mutations, allowing for personalized monitoring and treatment planning.
Natera is committed to advancing the field of ctDNA (circulating tumor DNA) analysis and developing new applications for Signatera in oncology and beyond.
As the field of ctDNA analysis continues to evolve, Natera and Signatera are poised to play a leading role in improving cancer care through personalized and precise monitoring and treatment strategies.
Natera is a biotechnology startup dedicated to enhancing precision medicine using genomic analysis. The company was founded in 2003 in San Carlos, California, and has operations in the United States, Europe, and Asia. The exclusive technology of Natera comprises very sensitive and accurate molecular diagnostic tests for a variety of illnesses, including cancer, reproductive health, and organ transplantation.
The company offers ctDNA analysis services using its Signatera assay, which can detect tiny quantities of tumor DNA in blood sample (s) and monitor treatment response and cancer recurrence in patients with solid tumors.
Natera provides non-invasive prenatal testing (NIPT) and preimplantation genetic testing (PGT) for in vitro fertilization (IVF) embryos as part of its reproductive health services. Donor-derived cell-free DNA (dd-cfDNA) testing, which can detect rejection episodes in organ transplant patients earlier than other approaches, is part of the company's organ transplant portfolio.
Natera is dedicated to developing genomes and precision medicine through continual research and development, strategic alliances, and collaborations with top academic and clinical institutions. The objective of the organization is to enhance patient outcomes and quality of life through tailored and accurate diagnosis, treatment, and monitoring measures.
Mridula George, MD, is a medical oncologist and hematologist at Rutgers Cancer Institute in New Brunswick, New Jersey in her clinical practice, where she specializes in the treatment of solid tumors, including breast cancer, lung cancer, and gastrointestinal cancers, as well as hematologic malignancies. Dr. George completed her medical degree at the Government Medical College in Thiruvananthapuram, India, and went on to complete a residency in internal medicine at Saint Peter's University Hospital in New Brunswick. She then completed a fellowship in hematology and oncology at Rutgers Cancer Institute, where she currently serves as an assistant professor of medicine.
Dr. George is dedicated to providing personalized and compassionate care to her patients, using the latest advances in cancer treatment to improve outcomes and quality of life. Her research interests include exploring new targeted therapies (e.g. clinical trials for gene mutations, e.g. targeted therapy for precision medicine) and immunotherapies for solid tumors, as well as studying the use of circulating tumor DNA (ctDNA) for treatment monitoring and predicting treatment response because there are no exact sciences. Dr. George is board-certified in internal medicine, hematology, and medical oncology, and is an active member of several professional organizations, including the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).