Liquid Biopsy in Cancer Care
The North America liquid biopsy market is projected to reach USD 17.4 billion by 2035, with circulating tumor DNA (ctDNA) leading the biomarker segment, as of July 24, 2026. As of July 24, 2026, recent developments include Caris Life Sciences launching Caris Detect™, a multi-cancer early detection blood test, and UnitedHealth Group covering Guardant Health's Shield™ blood test for colorectal cancer screening. The SHERLOCK clinical trial also launched in Toronto, Canada, enrolling over 7,000 cancer survivors to assess liquid biopsies for recurrence detection. Additionally, the NCCN updated its Bladder Cancer guidelines to recommend multiplex PCR MRD testing using Signatera technology, and Quest Diagnostics' Haystack MRD test received New York State approval, making it available nationwide.
Timeline
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July 2026 — 6 developments
Liquid Biopsy Market Grows, New Early Detection Tests Launched, and ctDNA Shows Promise for Early Lymphoma Detection
The North America liquid biopsy market is projected to reach USD 17.4 billion by 2035, with ctDNA leading the biomarker segment. Recent developments include Caris Life Sciences launching Caris Detect™, a multi-cancer early detection blood test, and UnitedHealth Group beginning to cover Guardant Health's Shield™ blood test for colorectal cancer screening. Research also suggests ctDNA analysis can identify lymphoma-associated mutations years before clinical diagnosis.
NCCN updates bladder cancer guidelines for liquid biopsy testing; new trials underway
The NCCN has updated its Bladder Cancer guidelines to recommend multiplex PCR MRD testing using Signatera technology, and the MODERN trial is using ctDNA to guide treatment decisions. Preliminary results from the TOMBOLA trial indicate ctDNA positivity can precede radiographic recurrence. The EACR Liquid Biopsies 2026 Conference is scheduled for September 22-24, 2026.
New Clinical Trials Launched to Assess Liquid Biopsy in Cancer Recurrence Detection and Treatment
The five-year SHERLOCK clinical trial has launched in Toronto, Canada, enrolling over 7,000 cancer survivors to determine if liquid biopsies can detect disease recurrence. Separately, the CATE trial is evaluating elacestrant for high-risk breast cancer identified by liquid biopsy, with participants testing positive for ctDNA initiating treatment.
AstraZeneca Submits New Data to FDA for Camizestrant After ODAC Vote
AstraZeneca has submitted additional data to the FDA for its camizestrant application, following a vote by the Oncologic Drugs Advisory Committee (ODAC) against recommending the drug's use based solely on ctDNA detection of an ESR1 mutation before radiographic progression.
ctDNA Data at ESMO GI Congress 2026 Shows Potential for Personalized Colorectal Cancer Treatment
Discussions at the ESMO Gastrointestinal Cancers Congress 2026 highlighted the potential of circulating tumor DNA (ctDNA) to personalize treatments and predict overall survival benefits in metastatic colorectal cancer. Novel data were presented supporting the use of liquid biopsy to guide cetuximab rechallenge in metastatic colorectal cancer.
Quest Diagnostics' Haystack MRD Test Approved Nationwide for Cancer Detection
Quest Diagnostics' Haystack MRD test has received New York State approval, making it available nationwide for residual cancer detection. This development highlights advances in ctDNA and liquid biopsy applications, though challenges in standardization and validation remain.
June 2026 — 26 developments
European Medicines Agency Recommends Liquid Biopsy for Metastatic Breast Cancer Treatment
The European Medicines Agency recommended approval for a therapeutic strategy using liquid biopsy to monitor ESR1 mutations in metastatic breast cancer, showing improved progression-free survival. BillionToOne's Northstar Response® assay also demonstrated stronger prediction of immunotherapy outcomes compared to standard imaging.
Liquid Biopsy Advances: New Trials, Guidelines, and Treatments Emerge
Natera and Aveta Biomics are partnering for a global Phase 3 trial in head and neck cancer, utilizing Natera's Signatera ctDNA test to measure minimal residual disease. Separately, new NCCN guidelines now support the use of Natera's Signatera MRD test in muscle-invasive bladder cancer. Additionally, a study demonstrated ctDNA's strength in predicting immunotherapy outcomes, and Abu Dhabi launched personalized breast cancer treatment using ctDNA.
Blood Test Detects 10 Cancers Simultaneously; Trial Explores ctDNA-Guided Breast Cancer Treatment
A large real-world study presented at ASCO Breakthrough 2026 indicated that a blood test analyzing ctDNA could detect 10 different types of cancer simultaneously in their early stages. The CATE clinical trial is also exploring the utility of ctDNA-guided adjuvant therapy with elacestrant in hormone receptor-positive, HER2-negative breast cancers at risk for late recurrence.
SERENA-6 Trial Data Shows Camizestrant Extends PFS2 in Advanced Breast Cancer
Final Progression-Free Survival 2 (PFS2) data from the SERENA-6 trial, presented at ASCO 2026, demonstrated that switching to camizestrant plus a CDK4/6 inhibitor upon emergent ESR1 mutation detection extended PFS2 compared to continuing with an aromatase inhibitor (AI) plus a CDK4/6 inhibitor. The median PFS2 was 25.7 months for the camizestrant group versus 19.1 months for the AI group.
Urine-Based Liquid Biopsy Shows Higher Detection Rate for Early Urological Cancers in Study
A preliminary study in Singapore suggests urine-based liquid biopsy may be more effective than blood tests for detecting early urological cancers. The research found that analyzing ctDNA in urine identified cancer gene alterations in 92.3% of bladder cancer cases, significantly higher than the 15.4% detection rate with blood tests.
Liquid Biopsy Advances: New Assays, Trial Insights, and Early Relapse Detection Reported
Myriad Genetics has expanded its Precise MRD assay to include breast, colorectal, and renal cancers, demonstrating ctDNA's ability to predict pathologic complete response with 100% specificity. Secondary analyses of the DAPHNe trial suggest ctDNA may guide treatment de-escalation for ERBB2-positive breast cancer, while exploratory analyses from the SERENA-6 trial indicate higher ctDNA clearance rates with camizestrant. A study utilizing ctDNA sequencing for osteosarcoma relapse detection showed it preceded radiographic imaging by an average of 92.6 days.
Liquid Biopsy Findings Presented at ASCO 2026 Show Treatment Prediction and Market Growth
Analysis presented at ASCO 2026 indicates that ctDNA clearance can identify patients with deep and durable clinical benefit from enfortumab vedotin plus pembrolizumab in advanced urothelial carcinoma. Separately, a study presented at EBCC15 found that ctDNA detection after neoadjuvant therapy can predict breast cancer relapse. The global breast cancer liquid biopsy market is projected to reach $3.42 billion by 2035.
FDA Approves First Blood-Based MRD Companion Diagnostic for Bladder Cancer
The FDA has approved Signatera CDx as the first companion diagnostic for blood-based minimal residual disease testing in muscle-invasive bladder cancer with atezolizumab. Additionally, Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel to date, has received approval for comprehensive genomic profiling of solid tumors. Natera's Signatera also gained PMDA approval in Japan for MRD testing in colorectal cancer.
NCCN guidelines updated to include ctDNA testing for bladder cancer
The National Comprehensive Cancer Network (NCCN) has updated its guidelines to incorporate ctDNA-based molecular residual disease (MRD) testing into the treatment algorithm for patients with muscle-invasive bladder cancer (MIBC). This inclusion reflects the growing utility of liquid biopsies in cancer management.
Camizestrant Administered to First Patient in Abu Dhabi Clinical Setting
Abu Dhabi has become the first location globally where camizestrant has been administered to a patient in a clinical care setting. This follows its approval in the UAE, as updated data from the SERENA-6 trial continues to show a progression-free survival benefit for camizestrant in advanced breast cancer patients with emergent ESR1 mutations. The FDA has extended its review period for camizestrant.
Grail Shareholders Sue Over MCED Test Performance; FDA Extends Camizestrant Decision Date
Grail shareholders have filed a class-action lawsuit alleging false statements about their multi-cancer early detection (MCED) test's performance. Separately, the FDA has extended its decision date for camizestrant, while ESMO Daily Reporter highlights ongoing challenges in validating liquid biopsy platforms and standardizing protocols for clinical implementation.
ASCO Releases First Guideline for ctDNA Testing in Cancer Care
The American Society of Clinical Oncology (ASCO) has released its inaugural guideline for ctDNA testing in solid tumors and lymphoma. The guideline recommends its use as a complementary tool alongside standard diagnostic methods like imaging, providing practical advice for oncologists.
Liquid Biopsy Research Shows Circulating Tumor DNA Detectable Years Before Diagnosis
Research published in Cancer Discovery indicates that circulating tumor DNA can be detected more than three years prior to a clinical cancer diagnosis. This finding underscores the growing importance of liquid biopsy in proactive cancer screening and management through multicancer early detection (MCED) tests.
FDA Approves Belzutifan and Pembrolizumab for ccRCC; SERENA-6 Trial Shows Camizestrant Benefits
The FDA approved belzutifan in combination with pembrolizumab for the adjuvant treatment of adult patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence. Additionally, the SERENA-6 trial showed progression-free survival benefits of switching to camizestrant plus a CDK4/6 inhibitor upon ESR1 mutation emergence in advanced HR-positive breast cancer, with over 50% of patients achieving ctDNA clearance.
FDA Approves Guardant360 CDx as Companion Diagnostic for HER2-Mutant Lung Cancer Therapy
Guardant360 CDx has received FDA approval as a companion diagnostic for Boehringer Ingelheim's HERNEXO, a targeted therapy for HER2-mutant advanced non-small cell lung cancer. This marks another indication for Guardant360 CDx, recognized as the first FDA-approved liquid biopsy for comprehensive genomic profiling.
ctDNA shows promise in NSCLC, urothelial carcinoma; camizestrant improves PFS in breast cancer
New research explores the use of ctDNA in non-small cell lung cancer (NSCLC) to help stratify survival in patients treated with radiotherapy, potentially leading to more personalized treatment strategies. In urothelial carcinoma, early ctDNA dynamics show promise as biomarkers for response to enfortumab vedotin plus pembrolizumab. Updated Phase 3 SERENA-6 trial data indicates camizestrant significantly improved progression-free survival in advanced breast cancer, with exploratory analyses showing reduced ctDNA levels.
Natera, CytoDyn Collaborate on ctDNA Analysis; Liquid Biopsy Aids Breast Cancer Resistance Insights
Natera and CytoDyn are collaborating to evaluate ctDNA dynamics for CytoDyn's metastatic colorectal cancer program. New findings published on June 9, 2026, reveal that liquid biopsy can aid in understanding endocrine resistance in breast cancer by identifying mutations linked to resistance. Data presented at the 2026 ASCO Annual Meeting on June 5, 2026, suggests that ctDNA testing can help refine adjuvant treatment decisions in colorectal cancer.
FDA Panel Votes Against Recommending Camizestrant Switch Strategy for Advanced Breast Cancer
The FDA's ODAC voted against recommending the switch strategy for camizestrant in advanced breast cancer, citing insufficient evidence of clinically meaningful benefit, despite updated Phase 3 SERENA-6 trial data showing improved progression-free survival. The FDA has extended its review period for the treatment.
SCL Healthcare Develops AI Platform for Multi-Cancer Early Detection via Blood Test
SCL Healthcare is developing a novel AI-powered platform using platelet RNA for multi-cancer early detection, aiming to identify cancer types from a single blood draw. Preliminary evaluations show over 91% accuracy for 13 cancer types and over 84% accuracy for early-stage cancers.
New methods enhance liquid biopsy analysis for improved cancer care
Swedish researchers have developed a new method, BayesCNA, capable of analyzing liquid biopsy samples with as little as 5% cancer DNA, a significant improvement over current methods. Additionally, Johns Hopkins Kimmel Cancer Center researchers created a machine learning model called plasmaCHORD that filters out biological noise in liquid biopsy samples, enhancing the ability to match therapies to patients' tumors. These advancements aim to improve cancer care and monitoring of tumor progression.
UK Cancer Charity Offers Free ctDNA Testing; New Study Links ctDNA to Early Breast Cancer Outcomes
Cancer Research UK is making ctDNA testing freely available to hundreds of patients with advanced solid tumors across the UK. Additionally, new prospective study findings demonstrate that ctDNA monitoring can predict relapse and survival outcomes in early breast cancer more accurately than standard measures, with ctDNA detection preceding clinical relapse by a median of 13.8 months in some cases.
New Liquid Biopsy Methods Explored for Cancer Treatment Prediction
A Northwestern Medicine study suggests analyzing cell-free DNA fragmentation patterns in blood tests could predict immunotherapy response in head and neck cancer patients. This differs from current mutation-focused liquid biopsy methods. Tethis S.p.A. has also launched nanotechnology tools to improve rare cell recovery from liquid samples for potential liquid biopsy applications.
Liquid Biopsy Advances: SERENA-6 Trial Data and New FDA Designation Highlight Progress
Updated progression-free survival data from the SERENA-6 trial, presented at ASCO 2026, showed a median PFS of 16.8 months for patients with ESR1-mutated advanced breast cancer switching to camizestrant plus a CDK4/6 inhibitor. Additionally, Zepto Life Technology received FDA Breakthrough Device Designation for its FungiFlex Mold Panel, a liquid biopsy test for invasive mold infections.
ASCO 2026: SERENA-6 Trial Data Shows 51% ctDNA Clearance with Camizestrant
New data from the SERENA-6 trial presented at ASCO 2026 indicates that 51% of patients achieved complete ctDNA clearance with camizestrant, correlating with an overall survival benefit. Additionally, research is exploring ctDNA's role in urothelial carcinoma and guiding breast cancer treatment via the CATE trial.
Camizestrant Trial Data Leads to Extended FDA Review, Shows 55% Reduction in Progression
The SERENA-6 trial data has led to an extended FDA review for camizestrant and a positive EU opinion, showing a 55% reduction in disease progression or death for advanced HR-positive breast cancer patients with ESR1 mutations when combined with a CDK4/6 inhibitor. Exploratory analyses also revealed a median 99% reduction in circulating tumor DNA (ctDNA) by week 8 in patients treated with camizestrant.
Liquid Biopsy Trials Show Promise; Indian Institute to Offer Services
Results from the CIRCULATE trial presented at ASCO 2026 suggest postoperative ctDNA testing can guide adjuvant treatment decisions in stage II colon cancer, while the FLAME trial showed osimertinib plus chemotherapy improved progression-free survival in advanced EGFR-mutant NSCLC patients with persistent plasma ctDNA. Separately, Nizam's Institute of Medical Sciences in Hyderabad is establishing a cancer genomics center and will soon introduce liquid biopsy services for cancer detection and monitoring.
May 2026 — 23 developments
New MicroRNA Liquid Biopsy Assay for Colorectal Cancer Under Development
Researchers are advancing a cell-free microRNA liquid biopsy assay into clinical studies to predict response and monitor resistance in colorectal cancer patients treated with EGFR inhibitors. Separately, the Pathlight blood-based method measuring ctDNA has shown potential in detecting breast cancer recurrence nearly four years before standard methods.
Foundation Medicine Launches New ctDNA Assay for Cancer Detection
Foundation Medicine has launched FoundationOne®MRD, a new assay for detecting circulating tumor DNA (ctDNA) using whole genome sequencing and digital PCR. The assay creates a personalized fingerprint to detect ctDNA by identifying structural variants in a patient's tumor specimen.
Liquid Biopsy Advances Presented at ASCO 2026, Improving Cancer Monitoring
Guardant Health and its collaborators will present 38 abstracts at the 2026 ASCO Annual Meeting, highlighting advances in liquid biopsy technology, including Guardant Reveal for minimal residual disease monitoring. NeoGenomics will also present research on ctDNA detection for molecular residual disease and solid-tumor genomic profiling. A Phase 2 EXTEND trial demonstrated that ctDNA testing significantly improves the monitoring of patients with early metastatic cancers.
New ctDNA-Guided Breast Cancer Trial Launched; ESTRO 2026 Research Highlights Treatment Utility
The CATE clinical trial has been launched to evaluate the utility of ctDNA-guided treatment in breast cancer, aiming to prevent metastatic relapse. Research presented at ESTRO 2026 suggests ctDNA can identify patients who will benefit from combined radiation and drug therapy, with detectable ctDNA at treatment start correlating with poorer outcomes.
ctDNA Blood Test Detects Breast Cancer Recurrence Years Earlier Than Standard Methods
A ctDNA blood test, Pathlight, has shown the ability to detect breast cancer recurrence up to nearly four years before standard methods. For patients who later developed metastatic disease, the test identified recurrence a median of 13.8 months earlier than clinically visible relapse.
FDA Extends Camizestrant Decision; Personalis Unveils New ctDNA Assay
The FDA has extended its decision date for AstraZeneca's camizestrant, citing the need to review additional data on ctDNA clearance and long-term efficacy, which will be presented at ASCO 2026. Separately, Personalis has announced a new ctDNA assay designed for early cancer detection.
Guardant Health Receives FDA Approval for Expanded AI-Enabled Liquid Biopsy Test
Guardant Health has received FDA approval for an expanded liquid biopsy test utilizing an AI-enabled multiomic technology platform. This approval enhances sensitivity in ctDNA detection, marking a step forward in liquid biopsy diagnostics.
EU Recommends AstraZeneca's Camizestrant; US Panel Had Concerns
The European Medicines Agency's CHMP has recommended approval for AstraZeneca's camizestrant in combination with a CDK4/6 inhibitor for advanced breast cancer patients with ESR1 mutations. This recommendation contrasts with a recent US advisory panel vote against recommending the drug due to concerns about trial design and lack of overall survival data.
EMA Recommends AstraZeneca's Etcamah; New ctDNA Data Presented at ESTRO and ASCO
The EMA's Committee for Medicinal Products for Human Use has recommended marketing authorization for AstraZeneca's Etcamah for advanced breast cancer, based on SERENA-6 trial results showing repeated ctDNA monitoring can identify emerging ESR1 mutations. Analysis from the Phase 2 EXTEND trial presented at ESTRO 2026 showed ctDNA testing provided new insights into treatment response for patients receiving metastasis-directed therapy. BioNTech has completed a ctDNA study for colorectal cancer, tracking patients to detect lingering cancer signals.
FDA Approves Tecentriq® for Bladder Cancer Patients with ctDNA Molecular Residual Disease
The FDA has approved Genentech's Tecentriq® for adjuvant treatment in muscle-invasive bladder cancer patients with ctDNA molecular residual disease post-cystectomy. This approval is based on findings from the IMvigor011 study, marking a new application of liquid biopsy in MIBC treatment.
EU Recommends Camizestrant Approval Based on SERENA-6 Trial; New ctDNA Breast Cancer Trial Launched
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca's camizestrant in the EU, based on SERENA-6 trial results showing improved progression-free survival. Additionally, a new clinical trial has been launched to demonstrate the utility of ctDNA-guided treatment in breast cancer using the NeXT Personal test and elacestrant.
New Data on Liquid Biopsy in Breast Cancer Trials Presented at ASCO 2026
AstraZeneca presented final progression-free survival 2 (PFS2) results and ctDNA clearance data from the SERENA-6 trial at ASCO 2026, linking ctDNA clearance to longer-term efficacy in advanced breast cancer patients with ESR1 mutations. The phase 2 CATE trial is investigating elacestrant for high-risk breast cancer identified by liquid biopsy for earlier recurrence detection. Gene Solutions also showcased AI-powered liquid biopsy innovations at TJCC 2026.
FDA approves expanded Guardant360 liquid biopsy panel; ctDNA shows promise in breast cancer treatment
The FDA has approved the Guardant360 Liquid CDx, an expanded liquid biopsy panel that assesses a 100x wider genomic footprint for comprehensive cancer profiling. Separately, data from the SERENA-6 trial indicates that ctDNA monitoring to guide treatment changes can improve outcomes in breast cancer patients with ESR1 mutations.
New Studies Highlight ctDNA's Role in Breast Cancer Treatment and India's Advancements
New trials are exploring the role of ctDNA surveillance in early breast cancer, particularly in triple-negative cases, and the SERENA-6 trial supports serial ctDNA testing for ESR1 mutations in advanced breast cancer. A Vanderbilt University study indicates liquid biopsies can assess and predict the evolving antitumor immune response to immunotherapy in breast cancer. India is also emerging as a regional cancer care leader with advancements in liquid biopsies for ctDNA.
ctDNA Dynamics Show Promise in Stratifying Recurrence Risk for Colorectal and Bladder Cancers
A prospective study suggests that ctDNA dynamics can help stratify recurrence risk in patients with liver-limited metastatic colorectal cancer undergoing liver resection. Recent data also indicate that ctDNA testing may serve as a prognostic tool for patients with muscle-invasive bladder cancer (MIBC), with potential applications in guiding adjuvant treatment decisions, predicting metastatic risk, and informing bladder-preserving strategies.
FDA Approves Guardant Health's Expanded Liquid Biopsy Panel; New Bladder Cancer ctDNA Study Presented
Guardant Health's next-generation Guardant360 Liquid CDx test received FDA approval on May 20, 2026, becoming the largest FDA-approved liquid biopsy panel with enhanced sensitivity for ctDNA detection. Separately, a study presented at ESMO 2026 on May 21, 2026, indicates that ctDNA testing after neoadjuvant chemotherapy and radical cystectomy can predict recurrence risk in muscle-invasive bladder cancer.
AI-assisted liquid biopsies show promise for early cancer detection and monitoring
AI-assisted liquid biopsies are showing promise for earlier cancer detection and more precise treatment monitoring by analyzing biomarkers in bodily fluids, including exosomes that carry tumor cell fingerprints. Circulating tumor DNA (ctDNA) is emerging as a critical tool for monitoring treatment response and guiding therapeutic decisions.
New Liquid Biopsy Assay Predicts Cancer Therapy Response Using Tumor Microenvironment Analysis
A new blood-based assay called LiquidTME analyzes the tumor microenvironment to predict patient outcomes and treatment efficacy. This AI-driven approach uses plasma cell-free DNA to identify specific 'spatial ecotypes,' offering a more personalized method for forecasting response to various cancer therapies.
ctDNA Testing Shows Value in Monitoring Treatment Response for Oligometastatic Cancers
New research presented at ESTRO 2026 indicates that ctDNA testing can offer valuable insights into treatment response for patients undergoing metastasis-directed therapy for oligometastatic cancers. Detecting ctDNA after treatment may signal persistent disease or treatment ineffectiveness, while ctDNA clearance is linked to better outcomes.
FDA Approves First ctDNA-Guided Therapy; Liquid Biopsy Use Expands
The FDA has approved atezolizumab as the first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, based on the IMvigor011 study. Concurrently, Synnovis and SOPHiA GENETICS are expanding liquid biopsy testing for lung and breast cancer in the UK as part of an NHS initiative. Additionally, the SERENA-6 trial supports repeated ctDNA monitoring for ESR1 mutations in advanced breast cancer, and the CATE clinical trial has launched to assess ctDNA-guided adjuvant therapy in breast cancer patients.
ctDNA Shows Promise in Breast Cancer Treatment, Faces Limitations in Melanoma
ctDNA detection is linked to worse survival in resectable melanoma, though high false-negative rates may limit its use for surveillance or treatment de-escalation. In metastatic breast cancer, ctDNA is a standard tool for identifying mutations that guide targeted therapies, potentially replacing invasive tissue biopsies. However, for early-stage breast cancer, ctDNA's utility is still largely in the research phase.
ctDNA Dynamics Linked to Outcomes in Metastatic Colorectal Cancer and Breast Cancer Treatment
Exploratory findings from the VALENTINO trial suggest a strong correlation between baseline ctDNA detection and early dynamics with clinical outcomes in metastatic colorectal cancer patients. Additionally, ctDNA analysis shows potential to transform treatment decisions for advanced or metastatic breast cancer by identifying critical mutations and offering a dynamic assessment compared to tissue biopsies.
Liquid Biopsies Face Challenges in Older Adults Due to Age-Related Changes
A review in npj Precision Oncology highlights that while liquid biopsies show promise for personalized cancer care in older adults, age-related biological changes like increased cell-free DNA and clonal hematopoiesis can complicate accuracy and potentially lead to false positives. Further research is needed to refine these tests for the geriatric population, though they offer a less invasive alternative to traditional tissue biopsies.
April 2026 — 21 developments
FDA Panel Rejects Camizestrant for Advanced Breast Cancer; Liquid Biopsy Shows Promise
An FDA advisory committee voted against the new drug application for camizestrant, a treatment for advanced breast cancer with ESR1 mutations. Concurrently, liquid biopsies are showing promise in lung, colorectal, and B-cell lymphoma care, with new trials launching for ctDNA-guided treatment in breast cancer and early diagnosis of EBV-positive Burkitt lymphoma.
New liquid biopsy methods and ctDNA applications emerge in cancer research
New liquid biopsy methods like 'Bridge Capture' are being developed to enhance sensitivity and coverage for clinical testing and treatment selection. Additionally, circulating tumor DNA (ctDNA) is being investigated for its utility in de-escalating treatment for older breast cancer patients, diagnosing conditions in resource-limited settings, and guiding chemo-free neoadjuvant therapy.
MSKCC develops AI-nanosensor liquid biopsy for brain tumor detection
Researchers at Memorial Sloan Kettering Cancer Center have developed a novel liquid biopsy technique that uses artificial intelligence and nanosensors to detect brain tumors with 98% accuracy by analyzing proteins in the bloodstream. This method is significant as it bypasses the limitations of traditional DNA-focused liquid biopsies, which struggle to detect markers that do not easily cross the blood-brain barrier.
FDA grants Breakthrough Designation to CatCHimera liquid biopsy platform; new studies show promise in cancer monitoring and early detection
The FDA has granted Breakthrough Device Designation to the CatCHimera liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma, utilizing viral DNA markers. A study in Science Translational Medicine demonstrates that liquid biopsies can assess and predict immune response to immunotherapy in breast cancer patients. Additionally, a novel Epigenetic Instability Index (EII) liquid biopsy has been developed to detect early-stage lung and breast cancers with high accuracy by measuring DNA methylation patterns.
Immuneering presents new ctDNA data at AACR; CelLBxHealth and Royal Marsden collaborate on CTC-DNA study
Immuneering Corporation presented new ctDNA data at the AACR Annual Meeting, indicating that acquired MAPK pathway alterations are rare in patients treated with atebimetinib, suggesting sustained clinical benefit. Additionally, CelLBxHealth and The Royal Marsden NHS Foundation Trust are collaborating on a study using CTC-DNA for advanced non-small cell lung cancer patients with uninformative ctDNA tests.
Roche acquires SAGA Diagnostics' tumor-informed MRD platform for Foundation Medicine
Roche is acquiring SAGA Diagnostics' tumor-informed molecular residual disease (MRD) platform, which will be integrated into Foundation Medicine's monitoring portfolio. This acquisition aims to strengthen capabilities in detecting and monitoring cancer recurrence.
Myriad Genetics and SAGA Diagnostics Present Data on MRD Tests for Cancer Monitoring
Companies are developing multi-cancer early detection tests with expected commercial availability in the latter half of 2026, while artificial intelligence is being explored to interpret ctDNA data for tracking progression and early detection of resistance. Myriad Genetics is presenting data on its Precise MRD assay for treatment monitoring and surveillance, and SAGA Diagnostics will present data on its ultrasensitive Pathlight™ MRD test for ovarian and metastatic breast cancer.
NeoGenomics' PanTracer LBx liquid biopsy test receives Medicare coverage
NeoGenomics announced that its PanTracer LBx liquid biopsy test has received Medicare coverage, expanding access to comprehensive genomic profiling for patients. This development is part of broader advancements in liquid biopsy and ctDNA research for cancer detection, monitoring, and treatment guidance.
AACR 2026 Sub-Study Shows ctDNA Predicts Recurrence in Early Triple-Negative Breast Cancer
At AACR 2026, a sub-study of the NSABP B-59/GBG-96-GeparDouze Trial showed that ctDNA detection after neoadjuvant treatment predicts recurrence in early triple-negative breast cancer. Separately, results from the SERENA-6 trial indicate that switching therapy based on ctDNA-detected ESR1 mutations improves progression-free survival in advanced HR+/HER2- breast cancer patients. Research also indicates ctDNA levels correlate with outcomes in advanced prostate cancer monitoring.
Mayo Clinic and SAGA Diagnostics present liquid biopsy advancements at oncology conferences
The AACR Annual Meeting and the World Conference on Oncology, Liquid Biopsy & Biomarkers are showcasing advancements in liquid biopsy and ctDNA research, including new diagnostic tools and therapeutic strategies. Mayo Clinic is discussing liquid biopsy's role in cancer detection, while SAGA Diagnostics is presenting data on its Pathlight MRD test for cancer monitoring.
Quest Diagnostics' Haystack MRD test implemented at City of Hope for solid tumor clinical trials
Quest Diagnostics' Haystack MRD test is being implemented at City of Hope for clinical trial participants with solid tumors to evaluate its role in guiding disease management and early recurrence detection. SAGA Diagnostics presented data at AACR 2026 on its Pathlight MRD test, showing ultrasensitive ctDNA detection for predicting patient outcomes in metastatic breast and ovarian cancers. Ultima Genomics also showcased its ppmSeq technology at AACR 2026, demonstrating low single-digit parts-per-million sensitivity for ctDNA detection.
New blood test detects multiple cancers; study links ctDNA to cervical cancer relapse
A new low-cost blood test analyzing DNA methylation patterns has been developed to potentially detect multiple cancers, including early-stage ones, and identify their tissue of origin. Separately, a new study indicates that ctDNA positivity after definitive treatment strongly predicts relapse in locally advanced cervical cancer, with all recurrences occurring in ctDNA-positive patients.
Myriad Genetics and Ultima Genomics Present New Breast Cancer Data at AACR Meeting
Myriad Genetics is presenting new findings from its MONITOR-Breast study at the AACR Annual Meeting, characterizing ctDNA dynamics during neoadjuvant therapy for breast cancer and associating distinct ctDNA response patterns with pathological response. Ultima Genomics presented initial TRACERx MRD data showcasing the performance of its ppmSeq technology in detecting ultra-low levels of circulating tumor DNA.
Quest Diagnostics advances Haystack MRD platform for cancer clinical trials
Quest Diagnostics is advancing its Haystack MRD platform, a ctDNA-based test, for clinical trials to guide disease management in breast, colorectal, ovarian, and prostate cancers. The CATE trial is investigating elacestrant, guided by liquid biopsy, in women with HR+/HER2- breast cancer at high risk for recurrence to detect and intervene in early signs of recurrence.
Spain aims to become global biomedical innovation hub by incorporating liquid biopsy into clinical care
ctDNA analysis is increasingly driving treatment decisions and moving beyond academic settings, with protocols expected to undergo revision. Spain aims to become a global hub for biomedical innovation by progressively incorporating liquid biopsy into routine clinical care. Ultra-sensitive assays are crucial for isolating ctDNA for early detection of recurrence and therapy response monitoring.
Croatia's Institute for Personalised Medicine plans to expand liquid biopsy use for cancer.
Croatia's Institute for Personalised Medicine, ranked third globally for precision tumor testing, plans to broaden its use of liquid biopsy techniques to enhance cancer diagnosis and treatment monitoring.
Invivoscribe introduces PrepQuant™ System; SERENA-6 trial supports camizestrant for breast cancer.
Invivoscribe has introduced the PrepQuant™ System, an integrated platform designed to standardize sample preparation for molecular testing, including liquid biopsies. Patient-reported outcomes from the SERENA-6 trial also support the combination of camizestrant with a CDK4/6 inhibitor for advanced breast cancer with ESR1 mutations, showing improved progression-free survival.
FDA reviews camizestrant for breast cancer, grants plixorafenib breakthrough therapy for glioma
The FDA is reviewing camizestrant for earlier use in breast cancer treatment, based on SERENA-6 trial data. Additionally, breakthrough therapy designation has been granted for plixorafenib for BRAF V600E-mutated high-grade glioma.
SERENA-6 Trial Focuses on Non-Small Cell Lung Cancer Treatment Efficacy
The SERENA-6 trial is now specified as focusing on patients with non-small cell lung cancer (NSCLC), investigating the efficacy of specific treatments. Further details on the trial's agents, patient eligibility, and locations are available on clinicaltrials.gov.
MethylScan technology enables cost-effective cell-free DNA methylome profiling for cancer detection
The MethylScan technology, detailed in PNAS, enables cost-effective cell-free DNA methylome profiling for cancer detection by depleting healthy DNA. Post-neoadjuvant therapy ctDNA positivity in breast cancer is linked to a higher chance of relapse, underscoring ctDNA's role in monitoring treatment response. The SERENA-6 trial demonstrated improved progression-free survival for advanced breast cancer with ESR1 mutations by switching to camizestrant based on ctDNA detection. GRAIL's Galleri liquid biopsy continues to show value in early cancer detection, supported by revenue growth and expanding partnerships.
UCLA Researchers Develop MethylScan Blood Test for Cancer and Liver Conditions
UCLA researchers have developed a new blood test called MethylScan that analyzes DNA methylation patterns to detect various cancers and liver conditions. This advancement is part of ongoing efforts to create cost-effective blood tests for early cancer detection and monitoring.
March 2026 — 3 developments
Natera's Signatera assay demonstrates clinical utility in anal squamous cell carcinoma and locally advanced rectal cancer
Researchers 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 announces breakthrough in liquid biopsy, isolating over 99% pure ctDNA from blood plasma
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.
PREDICT-DNA study identifies ctDNA as superior prognostic marker in breast cancer
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.
February 2026 — 10 developments
SERENA-6 Trial Shows Camizestrant Improves PFS in HR+/HER2- Breast Cancer
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.
Elacestrant improves progression-free survival in breast cancer patients in ELEVATE trial
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.
Liquid Biopsy Technology Enhances Colorectal Cancer Precision Medicine
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.
Friends of Cancer Research Validates ctDNA as Early Endpoint in Oncology Trials
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.
Study finds early ctDNA changes predict progression-free survival in breast cancer patients
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.
Personalis and Yale Cancer Center Launch CATE Clinical Trial for Breast Cancer Treatment
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.
Guardant Health's Guardant Reveal blood test more accurately identifies colon cancer recurrence risk
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.
Johns Hopkins Researchers Develop New Liquid Biopsy for Early Cancer Detection
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.
Molecular Residual Disease Testing Transforms Cancer Care with Improved Relapse Prediction
The integration of molecular residual disease (MRD) testing using highly sensitive liquid biopsy techniques to detect ctDNA is transforming cancer care by providing earlier and more precise indicators of recurrence risk. Serial ctDNA measurements have been shown to significantly improve relapse prediction, as indicated by studies presented in 2026.
SERENA-6 Trial Shows ctDNA Monitoring Improves PFS in Advanced Breast Cancer
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.
January 2026 — 4 developments
Southeast Asian Countries to Routinely Use Multi-Modal Liquid Biopsy Tests
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.
BLOODPAC Consortium introduces recommendations for ctDNA assay validation in cancer treatment.
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 Receives FDA Approval for Guardant360 CDx for Colorectal Cancer
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.
Study finds ctDNA predicts recurrence and chemotherapy benefit in rectal cancer patients
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.
December 2025 — 1 developments
SERENA-6 Trial Shows Camizestrant Improves Progression-Free Survival in HR+/HER2- Breast Cancer
The 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.
November 2025 — 1 developments
SERENA-6 Trial Shows Camizestrant Improves PFS in Breast Cancer Patients with ESR1 Mutations
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.
October 2025 — 1 developments
SERENA-6 Trial Data Supports Camizestrant for HR+/HER2- Breast Cancer; NeXT Personal Assay Shows ctDNA Dynamics Correlate with Treatment Response
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.
September 2025 — 2 developments
Mass General Brigham Researchers Develop HPV-DeepSeek for Early Head and Neck Cancer 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.
Personalis Launches CATE Clinical Trial with Yale Cancer Center for Breast Cancer Therapy
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.
June 2025 — 2 developments
SERENA-6 Trial Shows ctDNA Monitoring Improves Progression-Free Survival in Breast Cancer
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.
SERENA-6 Trial Demonstrates Liquid Biopsies Prolong Tumor Control 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.
Show earlier developments (13 more)
England and Wales pilot ctDNA liquid biopsies for lung cancer treatment
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.
Researchers develop MRD-EDGE, an ultrasensitive liquid biopsy for earlier cancer detection
Researchers 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.
Yale Develops New Blood Test for Early Detection of Multiple Cancer Types
A new blood test developed by Yale has shown high accuracy in detecting a wide range of cancers, including those difficult to screen for, by analyzing cell-free DNA fragments. The test identified cancer signals in 90% of patients across 12 cancer types, with over 75% detected at an early stage.
Global Liquid Biopsy Market Reaches USD 2.18 Billion in Value
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.
BLOODPAC Publishes Roadmap for Early Cancer Detection with Liquid Biopsy
BLOODPAC published a roadmap for early cancer detection and screening using liquid biopsy, outlining challenges and strategies for overcoming barriers to widespread adoption.
FDA approves first blood tests to identify cancer-related genetic changes
The 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.
FDA approves first ctDNA blood test for EGFR mutations in NSCLC
The 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).
FDA approves first liquid biopsy test for monitoring advanced metastatic cancers
The 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.
Catherine Alix-Panabières and Klaus Pantel coined the term 'liquid biopsy'.
The 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.
BEAMing Technology Verifies ctDNA Reflects Tumor Burden
BEAMing technology further verified that dynamic changes in circulating tumor DNA (ctDNA) could reflect tumor burden.
Circulating Tumor Cells proven important indicator for predicting breast cancer patient survival
Circulating Tumor Cells (CTCs) were proven to be an important indicator for predicting the survival of breast cancer patients, highlighting their diagnostic relevance.
Researchers prove cell-free nucleic acids in blood derive from tumor tissues
Researchers unequivocally proved that cell-free nucleic acids found in the blood were derived from tumor tissues, based on the presence of characteristic cancer mutations.
Researchers observe cell-free DNA in cancer patients' peripheral blood
Researchers made the novel observation that cancer patients carried cell-free DNA (cfDNA) in their peripheral blood.