Liquid Biopsy for Cancer Detection and Monitoring
VolitionRx Limited announced a breakthrough in liquid biopsy on March 18, 2026, becoming the first company to isolate and analyze over 99% pure circulating tumor-derived DNA (ctDNA) from blood plasma using their novel 'Capture-Seq' method. As of March 22, 2026, researchers are exploring ctDNA for personalizing breast cancer treatment, guiding adjuvant strategies in colon cancer, and for rapid diagnosis of Burkitt lymphoma in children in Africa. The PREDICT-DNA study indicates ctDNA clearance or persistence is a superior prognostic marker to pathologic complete response in HER2-positive or triple-negative breast cancer, while the SERENA-6 trial demonstrated improved progression-free survival with camizestrant upon ctDNA detection of ESR1 mutations in HR+/HER2- advanced breast cancer. Natera's Signatera assay has shown clinical utility in anal squamous cell carcinoma and locally advanced rectal cancer, and Personalis's NeXT Personal test received Medicare coverage for lung cancer surveillance.
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Track this story2026
16 updates
2026
16 updatesResearchers are exploring ctDNA for personalizing breast cancer treatment in older women and for guiding adjuvant strategies in colon cancer. A simple blood test using liquid biopsy shows promise for rapid diagnosis of Burkitt lymphoma in children in Africa. Natera's Signatera assay has demonstrated clinical utility in anal squamous cell carcinoma and locally advanced rectal cancer.
VolitionRx Limited has announced a breakthrough in liquid biopsy, becoming the first company to isolate and analyze over 99% pure circulating tumor-derived DNA (ctDNA) from blood plasma. Their novel 'Capture-Seq' method combines physical enrichment with bioinformatic filtering to overcome the challenge of DNA originating from healthy cells. This advancement addresses a key hurdle in cancer detection.
The PREDICT-DNA study indicates that ctDNA clearance or persistence is a superior prognostic marker to pathologic complete response in HER2-positive or triple-negative breast cancer. New research also suggests protein biomarkers can complement ctDNA for early cancer detection, particularly for early-stage cancers where ctDNA shedding may be intermittent. Additionally, ctDNA assays show promise in bladder cancer for predicting recurrence risk and in advanced breast cancer for quantitative HER2 profiling to improve treatment outcome predictions.
The SERENA-6 trial demonstrated that switching to camizestrant upon ctDNA detection of ESR1 mutations significantly improves progression-free survival (PFS) in patients with HR+/HER2- advanced breast cancer. Personalis's NeXT Personal test has received Medicare coverage for lung cancer surveillance, and Natera's MRD test shows broad utility across lymphoma subtypes and validation for colorectal cancer.
Updated data from the phase-2 ELEVATE trial indicate that elacestrant, when combined with everolimus or abemaciclib, improved progression-free survival (PFS) in patients with ER-positive, HER2-negative metastatic breast cancer, regardless of ESR1 mutation status. This suggests elacestrant's potential as a backbone for breast cancer combination regimens.
Recent advancements in liquid biopsy technology are enhancing precision medicine for colorectal cancer by enabling real-time monitoring of tumor evolution through the analysis of circulating tumor DNA (ctDNA). This approach provides insights into tumor genetics without invasive tissue biopsies, aiding in the detection of resistance mutations and identification of therapeutic targets.
via GeneOnline News
Friends of Cancer Research is building evidence to validate circulating tumor DNA (ctDNA) as an early endpoint in oncology clinical trials through its ctMoniTR project. This initiative aims to establish ctDNA as a reliable marker for treatment response, potentially accelerating drug development.
A phase 3b study published in Clinical Cancer Research found that early changes in circulating tumor DNA (ctDNA) strongly predict progression-free survival (PFS) in postmenopausal patients with HR+/HER2− advanced breast cancer treated with first-line ribociclib plus letrozole. Early ctDNA clearance was associated with improved PFS, and patients without new ctDNA alterations during treatment had a lower risk of progression.
via Docwire News
The CATE clinical trial has been launched to investigate the clinical utility of ctDNA-guided treatment in breast cancer, focusing on patients at risk for late recurrence. This trial is a collaboration between Personalis, Inc. and Yale Cancer Center. A recent podcast episode also explored the broad potential of liquid biopsies and ctDNA in cancer detection, treatment guidance, and monitoring.
New studies published in The Journal of Clinical Oncology and by Guardant Health indicate that a circulating tumor DNA (ctDNA) blood test, Guardant Reveal, can more accurately identify patients at high risk of colon cancer recurrence after surgery compared to current standard methods. These findings support the routine use of ctDNA testing in post-surgical colon cancer care.
Researchers at Johns Hopkins Kimmel Cancer Center developed a novel liquid biopsy method using the Epigenetic Instability Index (EII) for early-stage cancer detection. Additionally, Yale Medicine announced a Phase II trial (CATE) for ctDNA-guided adjuvant therapy in hormone receptor-positive, HER2-negative breast cancers.
The phase 3 SERENA-6 trial demonstrated that using ctDNA monitoring to guide treatment changes improved progression-free survival (PFS) in advanced breast cancer patients. Personalis' NeXT Personal assay received Medicare coverage for lung cancer surveillance, and FDA-approved MCED tests are set for Medicare coverage following a federal spending bill.
Multi-modal liquid biopsy tests, such as SPOT-MAS, are expected to be routinely used in Southeast Asian countries for screening high-risk populations, indicating growing global integration into routine healthcare.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
A new liquid biopsy test is being studied to predict how well patients with advanced breast cancer will respond to targeted therapies by analyzing circulating tumor DNA (ctDNA) for early feedback on treatment effectiveness. Additionally, the BLOODPAC Consortium has introduced consensus recommendations for standardized analytical validation protocols for tumor-informed ctDNA assays used to detect Molecular Residual Disease (MRD). These protocols offer a framework for essential performance metrics for ctDNA assays.
Guardant Health received FDA approval for Guardant360® CDx as a companion diagnostic for BRAFTOVI® combination in patients with BRAF V600E-mutant metastatic colorectal cancer, further expanding the clinical utility of liquid biopsies.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
A new study published in Annals of Surgery indicates that postoperative ctDNA (MRD) is a strong predictor of recurrence in rectal cancer patients with stage II-III disease. The study found that ctDNA-negative patients did not benefit from adjuvant chemotherapy, whereas ctDNA-positive patients showed significant benefit.
via oncodaily.com
2025
8 updates
2025
8 updatesThe SERENA-6 trial has demonstrated that switching to camizestrant based on molecular guidance significantly improves progression-free survival for patients with HR+/HER2- advanced breast cancer who have ESR1 mutations. The study indicated a 54% reduction in the risk of death when using camizestrant.
via ajmc.com
The SERENA-6 trial demonstrated that switching to camizestrant plus a CDK4/6 inhibitor upon detecting ESR1 mutations in ctDNA significantly improved progression-free survival in breast cancer patients. Additionally, a company is developing liquid biopsy blood tests, such as mDETECT, that analyze DNA fragments to monitor cancer progression, offering a cost-effective method for real-time treatment feedback.
via esmo.org·ctvnews.ca
New patient-reported outcome data from the SERENA-6 trial, presented at the 2025 ESMO Congress, further support switching to camizestrant for patients with HR+/HER2- advanced breast cancer and emergent ESR1 mutations, showing a consistent benefit in delaying time to deterioration. Separately, the NeXT Personal assay has demonstrated that ctDNA dynamics correlate with better treatment response and survival across 24 tumor types, with ongoing developments in detecting ctDNA in surgical drain fluid for molecular residual disease detection.
Researchers at Mass General Brigham developed HPV-DeepSeek, a new liquid biopsy tool capable of detecting HPV-associated head and neck cancers up to a decade before symptoms appear. This study was published in the Journal of the National Cancer Institute.
via youtube.com
Personalis, Inc. has launched the CATE clinical trial, a phase II study in collaboration with Yale Cancer Center, to investigate ctDNA-guided adjuvant therapy with elacestrant in hormone receptor-positive, HER2-negative breast cancers at risk for late recurrence. The trial will use the ultrasensitive Personalis NeXT Personal® test to detect the earliest molecular signs of recurrence before standard imaging. This aims to improve outcomes by enabling earlier intervention.
via Precision Medicine Online·cancerresearchuk.org·ascopost.com
The phase 3 SERENA-6 trial demonstrated that using circulating tumor DNA (ctDNA) monitoring to guide treatment changes before clinical progression significantly improved progression-free survival in patients with advanced breast cancer. An early switch to camizestrant upon ctDNA detection of ESR1 mutations resulted in a median PFS of 16.0 months compared to 9.2 months in the control group. The CATE clinical trial has also been launched to further explore the clinical utility of ctDNA-guided treatment in breast cancer.
The SERENA-6 Phase 3 trial demonstrated that using liquid biopsies to detect treatment-resistance mutations in advanced breast cancer, followed by a treatment change with camizestrant, significantly prolongs tumor control. This marks the first worldwide demonstration of clinical benefit for liquid biopsies in guiding treatment for hormone receptors-positive metastatic breast cancer.
Pilot projects are underway in England and Wales to evaluate the use of ctDNA-based liquid biopsies for accelerating lung cancer treatment and improving access to targeted therapies. These initiatives aim to assess the economic implications and potential for enhanced patient outcomes compared to standard care.
2024
2 updates
2024
2 updatesResearchers have developed MRD-EDGE, an ultrasensitive liquid biopsy technology that uses whole-genome sequencing and machine learning to detect cancer earlier than standard methods. This technology can distinguish cancer patterns from noise in blood samples.
The global liquid biopsy market for early cancer detection and monitoring was valued at USD 2.18 billion, reflecting significant commercial growth and investment in the technology.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2023
1 update
2023
1 updateBLOODPAC published a roadmap for early cancer detection and screening using liquid biopsy, outlining challenges and strategies for overcoming barriers to widespread adoption.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2020
1 update
2020
1 updateThe FDA approved the first blood tests (liquid biopsies) to identify cancer-related genetic changes by scanning DNA that tumors have shed into the blood. A study published in the Annals of Oncology also demonstrated that a liquid biopsy test could detect over 50 types of cancer, often before symptoms appeared.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2016
1 update
2016
1 updateThe FDA approved the first circulating tumor DNA (ctDNA) blood-based genetic test, the cobas EGFR Mutation Test v2, for detecting epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer (NSCLC).
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2013
1 update
2013
1 updateThe U.S. Food and Drug Administration (FDA) approved the first liquid biopsy test, the CellSearch® CTC enumeration platform, for monitoring patients with advanced metastatic breast, colon, and prostate cancers.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2010
1 update
2010
1 updateThe term 'liquid biopsy' was coined for the first time by Catherine Alix-Panabières and Klaus Pantel in a review exploring the challenges and opportunities of CTCs in cancer.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2008
1 update
2008
1 updateBEAMing technology further verified that dynamic changes in circulating tumor DNA (ctDNA) could reflect tumor burden.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2005
1 update
2005
1 updateCirculating Tumor Cells (CTCs) were proven to be an important indicator for predicting the survival of breast cancer patients, highlighting their diagnostic relevance.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1994
1 update
1994
1 updateResearchers unequivocally proved that cell-free nucleic acids found in the blood were derived from tumor tissues, based on the presence of characteristic cancer mutations.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1977
1 update
1977
1 updateResearchers made the novel observation that cancer patients carried cell-free DNA (cfDNA) in their peripheral blood.
via frontiersin.org·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1948
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