Liquid Biopsy For Early Cancer Detection Research Intelligence
Liquid Biopsy For Early Cancer Detection Research Landscape
Generated: June 16, 2026
Report Type: Research Intelligence
Data Sources: NIH RePORTER, ClinicalTrials.gov, USPTO, PubMed
How to Use This Report
NIH funding patterns validate research direction. Knowing who is funded in your space — with what methods, in what collaborations, and at what scale — calibrates where your work fits relative to the field's momentum and reveals gaps worth pursuing.
The intelligence in this report comes primarily from our semantic analysis across the linked data, not from any single source. NIH RePORTER, ClinicalTrials.gov, USPTO, and PubMed are all publicly searchable — anyone can look up individual records. Our value is in:
- Identifying conceptually-related projects via AI semantic search rather than brittle keyword matching
- Cross-linking each project to its associated patents, clinical trials, and publications
- Synthesizing across the analyzed sample to surface patterns no single record reveals — methodological trends, collaboration networks, gap analysis, and positioning signals
The Market Context section adds external color sourced via live web search. It is supplementary to the core analysis above.
What This Report Does Not Cover
A short, upfront note on the boundaries of this analysis. We surface this so you can read everything below with the right calibration.
- Companies are in this data — non-NIH-funded internal R&D is not. SBIR/STTR grantees, academic-industry partnerships, and commercial entities receiving NIH funding do appear and carry real commercial weight. What's invisible is privately-funded R&D inside companies that doesn't intersect with an NIH grant.
- International activity is largely outside the sample. NIH RePORTER captures US grantees and their direct collaborators. Major work in Europe, China, Japan, and elsewhere is not reflected unless tied to a US-funded project.
- Linked outputs require an NIH grant acknowledgment. A clinical trial, patent, or publication only appears here if it was filed with an NIH project number. Industry-led trials, non-USPTO patents, and papers without NIH funding acks are missing — even when central to the field.
- Recent quarter activity may be incomplete. NIH RePORTER updates with a lag of several weeks; some current-fiscal-year awards may not yet be visible.
- Umbrella institutional grants are not credited to topic funding. Some trials and patents in this report are hosted under broad institutional support awards (P30 cancer centers, CTSA hubs, training grants) whose parent grant covers many programs beyond this topic. Those records appear in the trials and patents sections, but the host grants' dollars are deliberately excluded from Total Committed Funding to keep the headline number topically attributable. Real topic activity at those institutions is therefore likely higher than the funding figures alone suggest.
- Market context is web-sourced, not exhaustive — see the Sources subsection in Market Context for what was retrieved.
- Project categorization is automated. A single primary category is assigned per project by AI classification, with confidence scores. Some boundary cases (especially infrastructure vs. biotools) may be misassigned.
This is depth-over-breadth analysis — high signal on what NIH funds and produces, including its commercial recipients. For a complete literature view, supplement with broader PubMed/Web of Science searches and conference proceedings.
Executive Summary
Among the projects analyzed, liquid biopsy for early cancer detection represents one of the most scientifically fertile spaces in oncology diagnostics, with a clear convergence around multi-analyte, epigenomics-first approaches as the dominant paradigm for improving sensitivity at early disease stages. The consistent investment in cfDNA methylation signatures, fragmentomics, and tissue-of-origin localization suggests the field has moved well past proof-of-concept and is now focused on clinical-grade validation and assay optimization - a meaningful shift in scientific maturity.
The institutional landscape reveals a concentration of leadership at a handful of research-intensive centers, with Johns Hopkins, UCLA, Stanford, and Massachusetts General Hospital each anchoring distinct but complementary technical approaches. Hopkins-affiliated work spans low-cost methylation platforms and multi-analyte biofluid strategies, while UCLA is pushing both methylome-based MCED and electrochemical detection in minimally processed samples. Stanford's nanopore-based epigenetic sequencing represents a methodological outlier worth watching, as long-read single-molecule platforms may unlock resolution advantages that short-read NGS cannot match. The most visible white space in this landscape appears to be the translation gap between analytically validated assays and prospectively powered clinical validation studies - a bottleneck that suggests collaboration opportunities between computational and assay development groups on one side, and large cooperative oncology networks with access to longitudinal biorepositories on the other.
Field momentum appears to be accelerating rather than maturing or plateauing. The step-up in funding from 2024 to 2025 is substantial and reflects a field responding to both commercial validation - the first FDA-approved blood-based CRC screening test, a major MCED regulatory filing - and genuine unmet clinical need. The concentration of trials in observational and biomarker validation phases, rather than interventional efficacy designs, suggests the field is in a critical transitional window where analytical performance is being locked in ahead of the larger randomized evidence generation that payers will ultimately require. The emergence of priming-agent strategies to transiently amplify ctDNA signal, point-of-care CRISPR-based detection, and saliva-based cfDNA platforms signals that analyte diversification and accessibility are active frontiers rather than settled questions.
For researchers positioning in this space, the most strategically valuable focus may be on the sensitivity-specificity tradeoff at stage I disease, where current assays still underperform clinically. Engagement with pre-diagnostic sample repositories, particularly from established screening trials like PLCO, appears to be a differentiating asset among funded investigators and could serve as a meaningful collaborator selection criterion. The FDA's move to formally regulate laboratory-developed tests will likely compress the commercialization window for platform developers operating outside traditional device pathways, making early regulatory strategy alignment - and partnerships with CLIA-certified laboratory networks - an increasingly important consideration for translational research programs.
Field Maturity Assessment
Note: This assessment is based on NIH-linked clinical trials, patents, and publications. It reflects patterns in the analyzed sample and may not represent the full global research landscape.
Technology Readiness: TRL 5-6
Overall Assessment: Maturing - Technology validation underway
Based on the linked trials and publications, liquid biopsy for early cancer detection appears to be at a mid-maturity stage, characterized by active clinical validation but not yet late-stage pivotal trials or broad commercial deployment. The pattern of substantial NIH funding ($96.7M across FY2024-FY2025), a robust publication base, and Phase 1-2 trial activity suggests a field that has moved well past proof-of-concept but has not yet achieved the Phase 3 evidence base typically required for widespread clinical adoption. Someone entering this space would find a competitive but still technically open landscape, where differentiated assay performance and clinical utility data remain key unresolved challenges.
Supporting Evidence
- Publication Maturity: With 200 linked publications, the 9% preprint ratio (17 preprints) is a plausible but not strongly interpretable signal on its own; the relatively low ratio does suggest the publication base leans toward peer-reviewed work, which is loosely consistent with a field past its earliest exploratory phase, though no strong conclusions should be drawn from this figure alone.
- Clinical Progression: The linked sample of 71 trials shows a distribution weighted heavily toward unphased or observational studies (60 of 71), with 8 Phase 2 and 3 Phase 1 trials present and no Phase 3 or Phase 4 trials observed, suggesting the field is generating clinical evidence but has not yet reached the late-stage confirmatory trials that would signal near-term regulatory approval or standard-of-care integration.
- IP Activity: With only 6 linked patents, recency ratios and trend interpretations are not statistically meaningful from this sample; the absence of recent filings in the last two years within this small set may reflect the sample's scope rather than a true signal about the broader IP landscape.
Competitive Topology
Note: Key players listed below are derived from NIH-funded project data and represent academic/research institutions. Commercial entities may not appear.
Based on this sample of NIH-funded projects, the competitive topology is anchored by cfDNA epigenetic profiling as the most mature and broadly pursued approach, with methylation and hydroxymethylation signatures driving multi-cancer early detection ambitions across several well-funded institutions. Fragmentomics and structural variant analysis represent a distinct competing methodology that extracts cancer signal from physical DNA fragment properties rather than sequence-level epigenetics, positioning it as a complementary or rival strategy depending on how multi-analyte panels evolve. A third competitive axis is emerging around signal enrichment and alternative biofluids, where nascent technologies attempt to solve the fundamental sensitivity ceiling that currently limits all cfDNA-based approaches; this cluster may ultimately serve as enabling infrastructure for the more mature detection methodologies rather than a standalone commercial category.
Methodological Clusters
| Approach | Key Players | Maturity | Commercial Readiness |
|---|---|---|---|
| cfDNA Epigenetic Profiling (Methylation and Hydroxymethylation Signatures) | Johns Hopkins University, Stanford University, University of California Los Angeles, University of Chicago, ... | Maturing | Among the most commercially advanced clusters in this sample, with multiple projects targeting multi-cancer early detection panels and PLCO cohort validation underway; commercial analogs such as Grail/Galleri exist outside this NIH-funded dataset and likely represent direct competitive pressure. |
| cfDNA Fragmentomics and Structural Variant Analysis | Johns Hopkins University, University of Wisconsin-Madison, Broad Institute, University of California Los Angeles | Emerging | Shallow whole-genome sequencing approaches for tumor fraction estimation are approaching analytical validation stages, but fragment-length and structural variant signatures for early detection remain earlier in clinical translation, with assay standardization still an active research challenge. |
| Alternative Biofluid and Non-Plasma Liquid Biopsy (Saliva, Urine, CSF) | Nord Bio Inc, Indiana University Indianapolis, Johns Hopkins University, University of California Los Angeles | Emerging | Proximity-enriched biofluids such as saliva for head and neck cancers and CSF for brain tumors show strong biological rationale, but this cluster is largely pre-commercial within this sample, requiring feasibility and sensitivity validation before clinical deployment. |
| Signal Amplification and Enrichment Strategies for Low-Abundance ctDNA | Vanderbilt University Medical Center, Massachusetts General Hospital, Harvard Medical School, University of Illinois at Urbana-Champaign, ... | Nascent | Approaches including in vivo cfDNA protection via engineered antibodies, priming agents for extracellular vesicle enrichment, and CRISPR/Cas-based point-of-care amplification are largely proof-of-concept stage, representing high-risk high-reward bets on fundamentally improving assay sensitivity rather than incremental platform refinement. |
| Circulating Tumor Cell Isolation and Extracellular Vesicle-Based Detection | Massachusetts General Hospital, Harvard Medical School, Cornell University (patent landscape) | Emerging | High-volume leukapheresis-based CTC isolation and tumor-derived extracellular vesicle mRNA profiling offer complementary transcriptional and proteomic information beyond DNA-centric approaches, but scalability and standardization barriers keep this cluster below the commercialization readiness of leading methylation-based cfDNA assays. |
Research Positioning
Competitive Positioning
Among the funded projects, three broad approaches dominate: (1) cfDNA-based methods spanning methylation profiling, fragmentomics, and copy-number analysis; (2) alternative analyte strategies including extracellular vesicles, saliva-based cfDNA, and circulating tumor cells via leukapheresis; and (3) platform and assay engineering efforts focused on cost reduction, miniaturization, and multiplexing. A new entrant could differentiate by targeting under-served cancer types beyond lung, breast, and colorectal, by focusing on the pre-analytic biology of cfDNA biogenesis (as in the Vanderbilt PARK project), or by combining multi-analyte readouts with non-plasma biofluids - a space that appears sparsely funded relative to plasma-centric approaches.
Collaboration Opportunities
Several projects show multi-PI or industry-academic partnership structures, including the NORD BIO INC saliva project and the Johns Hopkins Papadopoulos grant explicitly naming Belay Diagnostics as a CLIA validation partner, suggesting that translational co-development arrangements are increasingly common. Massachusetts General Hospital (9 projects, $7.5M) and UCLA (7 projects, $9.5M) carry the largest portfolio breadths, indicating these institutions have built internal ecosystems that could support collaborative grants. Researchers seeking partners might prioritize groups with existing biobank access to longitudinal pre-diagnostic samples such as the PLCO Trial cohort, which appears across multiple abstracts as a shared validation resource.
Methodological Trends
DNA methylation profiling - particularly 5mC and 5hmC signatures - appears to be a rapidly scaling approach with multiple independent groups applying it across cancer types, suggesting it is transitioning from exploratory to competitive. Fragmentomics and shallow whole-genome sequencing (as in the Broad Institute ULP-WGS project) represent maturing but still-evolving methods where analytical validation rather than discovery is now the primary challenge. Methodological gaps visible in this sample include limited investment in RNA-based liquid biopsy, limited integration of proteomics or metabolomics with cfDNA signals, and early-stage but underdeveloped work on nanopore long-read sequencing despite the Stanford Ji project suggesting its feasibility.
Gap Analysis
Based on this sample, cancers with high mortality but low screening infrastructure - including pancreatic (one project), ovarian, esophageal, and gastric cancers - appear underrepresented relative to lung and breast cancer, which dominate the portfolio. The biological mechanisms governing cfDNA release kinetics and clearance are addressed by only one project (Vanderbilt), suggesting that foundational biogenesis research is a relative white space despite its potential to unlock sensitivity improvements across all downstream assay types. Clinical implementation research covering cost-effectiveness modeling, health equity in screening access, and real-world adherence to liquid biopsy-guided workflows is largely absent from the visible abstracts, representing a gap that may grow in importance as tests approach regulatory submission.
NIH Funding Landscape
Among the examined projects, NIH funding in this sample strongly prioritizes cell-free DNA (cfDNA) methodology, with the majority of high-confidence projects focusing on methylation profiling, fragmentomics, and epigenetic signatures as the dominant analytical approaches for early cancer detection. The sample reveals a clear emphasis on multi-cancer early detection (MCED) frameworks - projects from UCLA, Johns Hopkins, and Stanford are developing pan-cancer blood tests that simultaneously interrogate multiple cancer types from a single blood draw, suggesting the field is moving away from single-cancer assays toward broader screening platforms. Lung cancer and colorectal cancer appear as the most frequently targeted tumor types, though pancreatic cancer draws notable attention given its poor prognosis and the potential value of early interception. The FY2025 funding level of $54.2M across this sample, compared to $42.5M in FY2024, indicates a meaningful year-over-year increase in investment, with FY2026 at $3.4M YTD reflecting an incomplete reporting period rather than any trend; this trajectory suggests sustained and potentially growing NIH commitment to liquid biopsy research across both academic medical centers and small biotech firms such as Nord Bio Inc. and XGenomes Corp.
Funding Summary
Funding figures sum award amounts across all budget periods for each project. Each fiscal year reflects actual spend in that year, not the most recent budget period only. Totals only include projects that meet the topic-relevance threshold — umbrella support grants (e.g., P30 cancer centers) that host a relevant trial but cover many unrelated programs are intentionally excluded so the headline number stays topically attributable.
| Metric | Value |
|---|---|
| Total Committed Funding | $102.1M |
| Active Projects | 125 |
| Funding Organizations | 66 |
| Principal Investigators | 133 |
Funding by Year
Lighter bar = partial fiscal year (YTD only); not directly comparable to fully-reported prior years.
| Year | Projects | Funding |
|---|---|---|
| FY2026 (YTD) | 7 | $3.4M |
| FY2025 | 91 | $54.2M |
| FY2024 | 90 | $42.5M |
Through June 2026; FY2026 ends Sep 30, 2026. The YTD figure should not be compared directly to fully-reported prior years.
Top Funding Categories
| Category | Projects | Funding |
|---|---|---|
| Diagnostics | 68 | $55.9M |
| Biotools | 26 | $20.3M |
| Therapeutics | 19 | $15.7M |
| Infrastructure | 3 | $4.6M |
| Basic Research | 6 | $2.4M |
Key Research Projects
Top Funded Projects
Funding is the sum of award totals across all budget periods for each project. Latest activity is the most recent fiscal year the project received an award.
1. EFIRM Liquid Biopsy Research Laboratory: Early Lung Cancer Assessment
- PI: WONG, DAVID T, University of California Los Angeles
- Funding: $3.6M (latest activity FY2025)
- Category: Diagnostics
Insight: The EFIRM platform advances liquid biopsy accessibility by enabling cfDNA detection directly from a droplet of blood without extensive sample processing, positioning it as a potential point-of-care solution for early lung cancer detection. Its electrochemical detection architecture represents a meaningful departure from NGS-dependent workflows, aligning with the broader field trend toward analyte diversification and lower-cost screening formats. The parallel development of a new cancer biomarker landscape optimized specifically for EFIRM detection suggests a tightly integrated assay-biomarker co-development strategy that could accelerate clinical-grade validation.
This application, Phase 2 of the EFIRM-Liquid Biopsy Research Laboratory is to advance liquid biopsy for early lung cancer detection by: 1) advance the EFIRM Liquid Biopsy (eLB) technology towards ultra-sensitive detection of cancer-associated cfDNA directly in a droplet of blood while 2) a new land...
2. Multi-modal Liquid Biopsy Early Assessment of Breast Cancer, Pancreatic Cancer, and Multiple Myeloma
- PI: KUHN, PETER, University of Southern California
- Funding: $2.8M (latest activity FY2025)
- Category: Diagnostics
Insight: This project is notable for its simultaneous pursuit of three distinct cancer types - breast, pancreatic, and multiple myeloma - each representing a different clinical scenario where liquid biopsy could either complement or replace a more invasive standard-of-care procedure. The inclusion of portal vein blood sampling for pancreatic cancer is a particularly differentiated approach, as it targets a higher-concentration analyte source upstream of systemic dilution, potentially addressing the sensitivity limitations that have historically hampered ctDNA detection in pancreatic malignancy. The academic-industry partnership with Epic Sciences also positions this work for faster translation, with biologically informed multi-omic profiling of circulating rare cells as a technical anchor that extends beyond cfDNA-centric paradigms.
This Liquid Biopsy Research Laboratory (LBRL) partnership team, led by PI Peter Kuhn (academic) and Co-I Rick Wenstrup (industry) of Epic Sciences, is advancing biologically informed liquid biopsy (LBx) technology to fill gaps in current clinical practice of early cancer assessment. The three scenar...
3. Liquid biopsy and radiomics for liver cancer surveillance
- PI: TAOULI, BACHIR, Icahn School of Medicine at Mount Sinai
- Funding: $2.6M (latest activity FY2025)
- Category: Diagnostics
Insight: This project addresses hepatocellular carcinoma, a cancer where current surveillance tools - primarily ultrasound - have well-documented sensitivity limitations in high-risk cirrhotic populations, making liquid biopsy integration particularly clinically urgent. By combining liquid biopsy with MRI-based radiomics in a large multiracial multi-institutional cohort, the study is designed to generate the kind of prospectively powered, population-relevant validation data that the field broadly needs to bridge the gap between analytical performance and clinical deployment. The multimodal fusion strategy also reflects a growing recognition that no single analyte or imaging approach will achieve standalone performance sufficient for early HCC interception.
It is imperative to develop new noninvasive tools for the detection of curable hepatocellular carcinoma, as this improves survival in these patients. We propose a rigorous and systematic evaluation of liquid biopsy (detection of tumor components released to the bloodstream) and magnetic resonance im...
4. DNA evaluation of fragments for early interception (DELFI) of Lung cancer
- PI: VELCULESCU, VICTOR E., Johns Hopkins University
- Funding: $2.0M (latest activity FY2025)
- Category: Diagnostics
Insight: The DELFI approach applies cfDNA fragmentomics to lung cancer detection, leveraging genome-wide nucleosome positioning patterns as a cancer signal rather than relying solely on mutation-based or methylation-based markers, which expands the detectable signal space particularly at early disease stages. A distinctive strength of this project is its focus on pre-neoplastic lesions and the question of lesion progression, which moves liquid biopsy utility upstream from detection toward interception - a scientifically ambitious and clinically high-value objective. The combination of retrospective accrued samples with a prospective lung screening population positions this work for both rapid analytical iteration and meaningful clinical validation within a single funding cycle.
Molecular based blood tests provide an accessible and affordable option for screening high risk populations for many common cancers, leading to early detection with better outcomes. We propose to study the origins and molecular characteristics of cell-free DNA fragments in pre-neoplastic lung lesion...
5. Monitoring Immunotherapy Response via Gene Silencing Landscapes in Cell-Free DNA
- PI: BARRETT, MICHAEL T, Binary Genomics, Inc.
- Funding: $2.0M (latest activity FY2025)
- Category: Therapeutics
Insight: While categorized under therapeutics, this project from Binary Genomics applies cfDNA-based gene silencing landscape profiling to monitor immunotherapy response in lung cancer, representing an extension of epigenomics-first liquid biopsy methodology into the treatment monitoring space. The use of methylation or chromatin accessibility signatures - rather than simple ctDNA quantification - to distinguish responders from non-responders reflects a more biologically nuanced approach to treatment monitoring that could yield earlier and more reliable response signals. This work is strategically positioned at the intersection of diagnostics and therapeutics, and its success could validate epigenomic cfDNA signatures as dynamic pharmacodynamic biomarkers rather than static detection tools.
Some lung cancer patients have robust and durable tumor responses to immunotherapy, whereas others derive no benefit from such treatment. A blood test that monitors for changes in the amount of tumor DNA in the circulation could help to distinguish responders from non-responders, thereby improving c...
6. Microbial and host biomarker development for detection and prognosis of early stage non-small cell lung cancer
- PI: SEGAL, LEOPOLDO NICOLAS, New York University School of Medicine
- Funding: $2.0M (latest activity FY2025)
- Category: Infrastructure
Insight: This project introduces a relatively underexplored analyte class to lung cancer detection by developing microbial signatures alongside host biomarkers, leveraging the growing evidence that the lung microbiome is altered in malignancy and may carry independent diagnostic or prognostic information. The focus on both diagnosis and prognosis of early-stage non-small cell lung cancer addresses a critical clinical gap where imaging-detected nodules require better biological characterization to guide management. As a biomarker development infrastructure project, it also has the potential to generate reference datasets and validated signatures that could be integrated into multi-analyte liquid biopsy panels being developed by parallel efforts in the field.
. The diagnosis and prognosis of early stage lung cancer, the leading cause of cancer deaths in the U.S., is challenging and there are no useful biomarkers leading to unnecessary invasive tests and poor outcome among those that have recurrence of disease. In this project, we will uncover microbial a...
7. Clinical Utility of a Combined Biomarker Approach to Diagnose Lung Cancer
- PI: GROGAN, ERIC L, Vanderbilt University Medical Center
- Funding: $1.9M (latest activity FY2025)
- Category: Therapeutics
Insight: This Vanderbilt-led trial takes a pragmatic clinical utility framing by enrolling patients with suspicious lung lesions - a real-world decision point where liquid biopsy has immediate actionable relevance - and evaluating combined biomarker and radiomics approaches against standard diagnostic pathways. Its prospective, multi-technology validation design directly addresses the translation gap between analytically validated assays and clinical-grade evidence, making it one of the more clinically proximate studies in this portfolio. The focus on the indeterminate pulmonary nodule population is strategically important because it is the segment where a reliable liquid biopsy test could most immediately reduce unnecessary invasive procedures and improve time to diagnosis.
Doctors continue to struggle to diagnose lung cancer early when it is most curable. Lung cancer screening along with breakthroughs in blood tests and sophisticated computerized imaging may help solve this problem. We propose to enroll patients with suspicious lung lesions in a trial to test these ne...
8. Lung Cancer Early Detection and Immunotherapy Response Prediction and Monitoring with an Exo-PROS Liquid Biopsy Assay
- PI: WU, YUN, State University of New York at Buffalo
- Funding: $1.9M (latest activity FY2025)
- Category: Therapeutics
Insight: The Exo-PROS assay targets tumor-derived exosomes as the primary analyte, simultaneously profiling multiple biomarker types within a single vesicle-focused workflow, which represents a distinct approach relative to the cfDNA-centric methods dominating the broader field. The emphasis on a simple, fast, and cost-effective format - alongside dual utility for early detection and immunotherapy monitoring - suggests a design philosophy oriented toward broad clinical deployability rather than maximal analytical complexity. Exosome-based platforms remain less mature than cfDNA assays in terms of standardization, but their cargo richness across protein, RNA, and DNA analytes offers a potential sensitivity advantage that this project is positioned to systematically evaluate.
Current screening and diagnostic tests for lung cancer such as low dose CT and tissue biopsy are limited by high false positive rate, radiation exposure and invasive procedure. Liquid biopsy detects tumor-derived biomarkers in blood, allows sequential sampling, complements medical imaging and risk f...
9. Expanding early cancer detection with high throughput OCEANA - Ovarian Cancer Exosome Analysis with Nanoplasmonic Array
- PI: LEE, HAKHO, Massachusetts General Hospital
- Funding: $1.8M (latest activity FY2025)
- Category: Biotools
Insight: The OCEANA platform applies nanoplasmonic array technology to high-throughput molecular profiling of extracellular vesicles, targeting high-grade serous ovarian cancer - a malignancy with acute unmet need for early detection tools given the absence of any validated screening test. The use of nanophotonic detection for EV analysis is a methodologically distinctive approach that offers label-free, high-sensitivity molecular characterization without the amplification steps required in nucleic acid-based assays. Validation in high-risk patient cohorts rather than general population controls reflects a well-calibrated clinical positioning strategy, targeting the population where positive predictive value will be most favorable and clinical impact most immediate.
We propose to translate a novel liquid biopsy platform for early cancer detection. Specifically, we will apply a forward-thinking nano-plasmonic platform for comprehensive, high-throughput molecular analyses of extracellular vesicles (EVs). We will rigorously address EVs' clinical utility to detect ...
10. Multi-cancer early detection using cell-free DNA methylome analysis
- PI: ZHOU, XIANGHONG JASMINE, University of California Los Angeles
- Funding: $1.8M (latest activity FY2025)
- Category: Diagnostics
Insight: This UCLA project advances the multi-cancer early detection paradigm by developing and validating a cfDNA methylome-based MCED test spanning four cancer types - colon, gastric, liver, and lung - representing a direct contribution to the epigenomics-first convergence that the field is organizing around. The inclusion of tissue-of-origin localization as a component of the detection framework reflects the current clinical requirement that MCED tests not only detect a signal but guide diagnostic workup, a capability that substantially increases clinical utility. Positioned at an institution also leading EFIRM-based electrochemical detection, this project reinforces UCLA's dual-track investment in both methylomic informatics and novel detection chemistries as complementary strategies for early cancer liquid biopsy.
This project will develop and validate an MCED test for the early detection and localization of colon/gastric/liver/lung cancers. If successful, it will be transformative in fighting against these types of cancer, and benefit human kind. 1
Market Context
Market Overview
Market context below is synthesized from current web search results. See sources at the end of this section. NIH funding patterns are integrated to bridge public research and commercial activity.
Liquid biopsy for early cancer detection is one of the fastest-growing segments in oncology diagnostics, leveraging non-invasive blood-based analysis of circulating biomarkers - primarily circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and cell-free DNA (cfDNA) - to detect cancer at earlier, more treatable stages. The field is being propelled by rising global cancer incidence, rapid advances in next-generation sequencing (NGS) and digital PCR technologies, and a strong clinical and commercial push toward multi-cancer early detection (MCED) tests that can screen for dozens of cancer types simultaneously from a single blood draw. North America dominates the global market, accounting for roughly 45-55% of revenue share, driven by favorable regulatory frameworks, reimbursement progress, and the presence of leading commercial players. NIH funding patterns appear to reinforce this geographic concentration: among the $102.1 million in NIH-funded projects analyzed across 125 grants, top-funded institutions include UCLA, Massachusetts General Hospital, Johns Hopkins University, Beckman Research Institute/City of Hope, and the University of Southern California - all U.S.-based academic medical centers with strong translational research programs. This public investment may indicate that foundational biomarker discovery, assay validation, and clinical utility studies continue to rely heavily on academic infrastructure, even as commercial players scale their platforms independently.
The competitive and regulatory environment has matured significantly in 2024-2025. Guardant Health's Shield became the first blood-based liquid biopsy to receive full FDA approval for colorectal cancer (CRC) screening in 2024, followed by CMS Medicare coverage for eligible adults. GRAIL filed a full FDA Premarket Approval (PMA) application for its Galleri multi-cancer early detection test in January 2026, backed by data from the 140,000-participant NHS-Galleri randomized controlled trial and the PATHFINDER 2 study. Meanwhile, Exact Sciences moved aggressively into the blood-based CRC screening space by acquiring U.S. rights to Freenome's test in August 2025 for $75 million upfront plus up to $700 million in milestones, setting up a direct three-way rivalry in the CRC screening segment. NIH funding trends through this period suggest sustained and growing public sector interest that may correlate with the broader commercialization wave: funding rose from $42.5 million in FY2024 to $54.2 million in FY2025, a notable year-over-year increase. FY2026 shows $3.4 million year-to-date as of June 2026, reflecting a partial year only, and should not be interpreted as a decline in funding activity. It is worth noting that NIH data captures publicly-funded academic research and does not reflect the substantially larger private R&D expenditures of commercial players such as Guardant Health, GRAIL, and Exact Sciences.
The technology landscape is being shaped by the convergence of epigenomics, genomics, and AI-driven signal detection, which is improving sensitivity for early-stage tumors - historically the biggest clinical limitation of ctDNA-based tests. The academic focus of NIH-funded institutions suggests that much of the upstream work on novel biomarker modalities, including methylation profiling and fragmentomics, is still being driven through public research channels, potentially creating a pipeline of innovations that commercial developers may later translate into approved products. However, a gap may exist between the diagnostics-oriented academic research captured in this NIH sample and the large-scale clinical validation and health economic evidence that payers require for reimbursement coverage decisions - an area where industry-sponsored trials currently play the dominant role. Regulatory attention is also increasing, with the FDA issuing final rules in May 2024 to bring laboratory-developed tests (LDTs) under formal device oversight, a move with significant implications for liquid biopsy developers that have historically operated under LDT pathways. Reimbursement and guideline inclusion remain key commercialization hurdles, particularly for MCED tests, where payer coverage policies are still evolving.
Market Sizing: $6.17 billion in 2024, projected to $22.69 billion by 2034 at a CAGR of 13.91% (Precedence Research, via BioSpace/GlobeNewswire, September 2025)
Key Players
These players are identified from market reports and trade press, and may differ from the NIH-funded organizations analyzed elsewhere in this report.
- Guardant Health (Shield CRC screening test, Guardant360 CDx, GuardantOMNI)
- GRAIL (Galleri multi-cancer early detection test)
- Exact Sciences (CancerGuard MCED test; licensed Freenome CRC test)
- Freenome (blood-based CRC screening; U.S. rights licensed to Exact Sciences)
- Foundation Medicine / Roche (FoundationOne Liquid CDx)
- Natera (Signatera MRD, Prospera transplant monitoring)
- Illumina (platform and sequencing infrastructure; former GRAIL parent)
- Thermo Fisher Scientific (liquid biopsy assay kits and instruments)
- Bio-Rad Laboratories (digital PCR platforms for ctDNA detection)
- Labcorp (PGDx elio plasma focus Dx, MRD and LBx solutions)
- Myriad Genetics (hereditary cancer testing and LBx partnerships)
- Mercy BioAnalytics (Mercy Halo ovarian cancer screening test)
- ClearNote Health (Avantect Multi-Cancer Detection Test)
- Sysmex Corporation
- QIAGEN
- NeoGenomics Laboratories
Recent Developments
- 2024-07: Guardant Health received full FDA approval for Shield as the first blood-based liquid biopsy approved for primary colorectal cancer screening in average-risk adults aged 45+, with concurrent CMS Medicare coverage for 45 million eligible individuals (Guardant Health 8-K, July 2024; MedCity News, July 2024)
- 2024-08: Labcorp received FDA De Novo marketing authorization for its PGDx elio plasma focus Dx, described as the first kitted, pan-solid tumor liquid biopsy test on the U.S. market (DeciBio, August 2024)
- 2024-11: FDA approved FoundationOne Liquid CDx as a companion diagnostic for tepotinib in adult patients with metastatic NSCLC with MET exon 14 skipping alterations (DeciBio, November 2024)
- 2024-11: FDA issued guidance on use of circulating tumor DNA (ctDNA) for early-stage solid tumor drug development, focusing on MRD and monitoring applications in clinical trials (DeciBio, November 2024)
- 2024-11: A jury awarded Guardant Health $292.5 million in a false-advertising lawsuit against Natera, a landmark ruling in the intensifying rivalry between the two companies (DeciBio, November 2024)
- 2024-11: OneCell Diagnostics raised $16 million in a Series A round to expand its OncoIndx Ikon next-generation liquid biopsy test to the U.S. market (DeciBio, November 2024)
- 2025-05: In May 2024, Mercy BioAnalytics received FDA Breakthrough Device Designation for its Mercy Halo Ovarian Cancer Screening Test for asymptomatic postmenopausal women (DelveInsight/GlobeNewswire, April 2025)
- 2025-05: Guardant Health introduced expanded cancer subtyping capabilities and biomarker identification features for Guardant360 on its Smart Liquid Biopsy platform (Grand View Research, 2025)
- 2025-06: Guardant Health's Shield multi-cancer detection (MCD) test received FDA Breakthrough Device designation (MarketsandMarkets, April 2026)
- 2025-08: Exact Sciences acquired exclusive U.S. rights to Freenome's blood-based colorectal cancer screening test for $75 million upfront and up to $700 million in milestones, with the test currently under FDA review and a potential U.S. launch targeted for late 2026 (STAT News, August 2025; MedCity News, September 2025)
- 2025-09: Guardant Health and Quest Diagnostics announced a multi-year strategic collaboration to expand access to the Shield CRC blood-based screening test across the United States (Guardant Health press release, September 2025)
- 2025-09: Guardant360 CDx received FDA approval as a companion diagnostic for Eli Lilly's imlunestrant (Inluriyo) for ESR1-mutated advanced breast cancer - its sixth FDA-approved companion diagnostic claim (DeciBio, October 2025)
- 2025-09: ClearNote Health received UKCA approval in the United Kingdom for its Avantect Multi-Cancer Detection Test and Avantect Ovarian Cancer Test (DeciBio, October 2025)
- 2025-09: Exact Sciences launched CancerGuard, a multi-cancer early detection test analyzing multiple biomarkers from blood (DeciBio, October 2025)
- 2026-01: GRAIL submitted the final module of its FDA Premarket Approval (PMA) application for the Galleri multi-cancer early detection test, supported by PATHFINDER 2 data (25,490 participants) and the 140,000-participant NHS-Galleri randomized controlled trial (GRAIL press release, January 2026)
- 2026-Q1: GRAIL announced planned integration of the Galleri test into Epic's electronic health record (EHR) platform to expand nationwide ordering access (GRAIL 8-K, 2026)
Competitive Landscape
The liquid biopsy market for early cancer detection is consolidating around a small number of well-capitalized commercial leaders while remaining highly contested at the innovation frontier. Guardant Health holds first-mover advantage in blood-based CRC screening following its 2024 FDA approval of Shield and subsequent Medicare coverage, and is aggressively expanding distribution via a multi-year partnership with Quest Diagnostics. GRAIL, the only standalone publicly traded MCED pure-play following its spin-off from Illumina, is pursuing full FDA approval for Galleri (50+ cancer types) via a PMA filed in January 2026, supported by the largest randomized controlled MCED trial ever conducted. Exact Sciences - the market leader in non-invasive CRC screening via its Cologuard stool test - is challenging Guardant directly by licensing Freenome's blood-based CRC test while simultaneously developing its own CancerGuard MCED platform. Foundation Medicine (Roche) and Natera anchor the companion diagnostics and MRD monitoring sub-segments respectively. Platform providers Thermo Fisher Scientific, Bio-Rad, Illumina, and QIAGEN compete at the instrument and reagent layer, supplying technology to clinical labs and test developers. Key competitive battlegrounds include: (1) MCED test sensitivity and specificity at early stages, (2) payer reimbursement and clinical guideline inclusion, (3) distribution reach and ordering convenience (evidenced by GRAIL's Epic EHR integration), and (4) LDT regulatory transition risk following the FDA's May 2024 final rule on laboratory-developed tests. Litigation is also a competitive tool - the $292.5 million false-advertising verdict against Natera in favor of Guardant Health in late 2024 signals that IP and marketing claims will be actively contested as the CRC and MCED markets commercialize.
Sources
Live web sources retrieved during report generation. Click to verify.
- www.openpr.com/news/4485588/liquid-biopsy-early-cancer-detection-market-set-for-strong
- www.researchandmarkets.com/reports/6202762/liquid-biopsy-early-cancer-detection-monitoring
- www.rootsanalysis.com/reports/liquid-biopsy-and-nicd-market/279.html
- www.grandviewresearch.com/industry-analysis/liquid-biopsy-market
- www.globenewswire.com/news-release/2025/09/16/3150822/0/en/Liquid-Biopsy-Market-Size-Worth-USD-22-69-Billion-by-2034-Amid-Rising-Demand-for-Minimally-Invasive-Cancer-Testing.html
- www.fortunebusinessinsights.com/liquid-biopsy-market-102506
- www.towardshealthcare.com/insights/us-liquid-biopsy-market-sizing
- www.biospace.com/press-releases/liquid-biopsy-market-size-to-surpass-usd-22-69-billion-by-2034-driven-by-early-cancer-detection-and-precision-diagnostics
- www.marketsandmarkets.com/ResearchInsight/liquid-biopsy-market.asp
- www.delveinsight.com/report-store/liquid-biopsy-in-cancer-diagnostics-market
- NIH RePORTER funding analysis
Clinical Validation Status
Note: This analysis includes only clinical trials linked to NIH-funded projects. Industry-sponsored and international trials may exist outside this sample.
The clinical trial data in this sample shows a field that remains heavily concentrated in observational and biomarker discovery phases, with the overwhelming majority of trials carrying a Phase N/A designation, indicating biomarker validation and specimen banking studies rather than interventional therapeutic trials. Lung cancer and breast cancer dominate the trial landscape, with large enrollment studies such as the ALCHEMIST Screening Trial (8,300 participants) and the Alliance colorectal screening trial (4,482 participants) suggesting that adequately powered validation cohorts are being assembled to establish clinical utility. The distribution of trial statuses - with 22 completed and 23 recruiting among the linked trials - indicates an active generation of prospective data, though the high number of terminated or withdrawn trials may reflect the technical and regulatory challenges inherent in validating liquid biopsy assays for early detection indications. Notably, ctDNA-guided therapy optimization is beginning to appear as a trial objective, as seen in the DLBCL study, suggesting a gradual pipeline maturation from pure detection toward treatment decision support applications.
Trial Summary
| Phase | Count |
|---|---|
| Phase 1 | 3 |
| Phase 2 | 8 |
| N/A | 60 |
Active Trials
ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL
- NCT ID: NCT06693830
- Phase: NA
- Status: RECRUITING
- Sponsor: Hua-Jay J Cherng, MD
- Conditions: Lymphoma, Lymphoma, B-Cell, Diffuse Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High-grade B-cell Lymphoma
- Enrollment: 40 participants
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
- NCT ID: NCT00003006
- Status: COMPLETED
- Sponsor: Alliance for Clinical Trials in Oncology
- Conditions: Lung Cancer
- Enrollment: 501 participants
Screening Tests in Detecting Colorectal Cancer
- NCT ID: NCT00025025
- Status: COMPLETED
- Sponsor: Alliance for Clinical Trials in Oncology
- Conditions: Colorectal Cancer
- Enrollment: 4,482 participants
Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix
- NCT ID: NCT00601601
- Status: COMPLETED
- Sponsor: British Columbia Cancer Agency
- Conditions: Cervical Cancer, Precancerous Condition
- Enrollment: 80 participants
Breath Test for Early Detection of Lung Cancer
- NCT ID: NCT00639067
- Status: COMPLETED
- Sponsor: Menssana Research, Inc.
- Conditions: Lung Neoplasms
- Enrollment: 215 participants
Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
- NCT ID: NCT00766454
- Status: COMPLETED
- Sponsor: Wake Forest University Health Sciences
- Conditions: Breast Cancer
- Enrollment: 1,104 participants
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
- NCT ID: NCT00843375
- Status: RECRUITING
- Sponsor: University of Michigan Rogel Cancer Center
- Conditions: Colonic Neoplasms
- Enrollment: 1,200 participants
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer
- NCT ID: NCT00897338
- Status: COMPLETED
- Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions: Breast Cancer
- Enrollment: 43 participants
Identification of Biomarkers for Early Detection of Pancreatic Cancer
- NCT ID: NCT00897494
- Status: COMPLETED
- Sponsor: Barbara Ann Karmanos Cancer Institute
- Conditions: Pancreatic Cancer
- Enrollment: 75 participants
Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
- NCT ID: NCT00898508
- Status: COMPLETED
- Sponsor: City of Hope Medical Center
- Conditions: Breast Cancer
- Enrollment: 563 participants
Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer
- NCT ID: NCT00898781
- Status: TERMINATED
- Sponsor: Mayo Clinic
- Conditions: Breast Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer
- Enrollment: 80 participants
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
- NCT ID: NCT00899028
- Status: COMPLETED
- Sponsor: Vanderbilt University Medical Center
- Conditions: Lung Cancer
- Enrollment: 689 participants
Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
- NCT ID: NCT00899457
- Status: COMPLETED
- Sponsor: Vanderbilt-Ingram Cancer Center
- Conditions: Healthy, no Evidence of Disease, Lung Cancer
- Enrollment: 37 participants
DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer
- NCT ID: NCT00899548
- Status: COMPLETED
- Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions: Breast Cancer
- Enrollment: 182 participants
Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer
- NCT ID: NCT00899639
- Status: WITHDRAWN
- Sponsor: Rutgers, The State University of New Jersey
- Conditions: Breast Cancer
Patent Activity
Note: This analysis includes only patents linked to NIH-funded projects. Commercial patents and international filings may exist outside this sample.
IP Concentration: Moderately Concentrated - Several key players
Dominant Patent Holders: Johns Hopkins University, Dana-Farber Cancer Institute, Cornell University
Recent Activity: The linked sample shows no patents filed in the last two years, suggesting either a slowdown in NIH-project-linked filings in this specific sample or a shift toward commercial patenting activity that falls outside this dataset.
Freedom to Operate Assessment
Among the NIH-linked patents, FTO concerns may center on nucleic acid assessment methods held by Johns Hopkins University, which accounts for two of the six sampled patents. The Cornell nanoparticle/exosome patent and the Dana-Farber mutation testing patent may also present potential overlap for entrants developing ctDNA or exosome-based detection platforms. Critically, this sample likely underrepresents the full FTO picture, as major commercial players such as Grail, Guardant Health, and Foundation Medicine hold extensive patent portfolios that do not appear in this NIH-linked set.
The NIH-linked patent sample appears to show academic institutions as the primary assignees, with Johns Hopkins, Dana-Farber, and Cornell collectively holding the identified patents - a pattern consistent with foundational research-stage IP rather than commercialization-stage filings. This concentration pattern suggests that core methodological approaches in liquid biopsy may have academic origins, which could mean licensing pathways through university tech transfer offices are relevant for a new entrant. However, the absence of commercial patents in this sample almost certainly reflects a data gap rather than a lack of commercial IP activity, and a comprehensive FTO analysis would require searching broader patent databases including USPTO, EPO, and WIPO directly.
Patent Analysis
Among the linked patents, the IP activity in this sample is modest in volume but concentrated in foundational sequencing and nucleic acid processing technologies, with Johns Hopkins holding two patents related to dual-strand barcoding and PCR-based enrichment workflows that underpin error-correction in ctDNA sequencing. Dana-Farber's denaturation-enhanced digital PCR patent points to IP protection around sensitivity improvements for low-abundance target detection, which is a core technical bottleneck for early-stage cancer detection where tumor-derived DNA fractions can be extremely low. Cornell University's exosome subtype patent extends IP coverage beyond cfDNA into extracellular vesicle biology, suggesting that assignees are hedging across multiple liquid biopsy analyte classes rather than consolidating around a single modality. The absence of recent patents (zero in the past two years among linked records) may indicate either a lag in patent publication timing or a period of pre-competitive research consolidation, though this observation should be interpreted cautiously given the curated nature of this sample.
Patent Summary
| Metric | Value |
|---|---|
| Total Patents | 6 |
| Unique Assignees | 3 |
| Recent (2 years) | 0 |
Key Patents
DENATURATION-ENHANCED DNA MUTATION TESTING FOR LIMITED BIOLOGICAL SPECIMENS
- Patent #: 11884970
- Assignee: DANA-FARBER CANCER INST
Disclosed herein are methods to improve the efficiency of absolute quantification of nucleic acid targets such as digital PCR and digital isothermal amplification, and/or reduce the amount of nucleic ...
Nanoparticles and Distinct Exosome Subsets for Detection and Treatment of Cancer
- Patent #: 12259389
- Assignee: CORNELL UNIVERSITY
The present invention is directed to methods of diagnosing, prognosing, and managing treatment of cancer in a subject. These methods involve selecting a subject having cancer and obtaining, from the s...
METHODS AND MATERIALS FOR ASSESSING NUCLEIC ACIDS
- Patent #: 12442038
- Assignee: JOHNS HOPKINS UNIVERSITY
Provided herein are systems, kits, compositions and methods for sequencing library preparation and sequencing workflow (e.g., for the identification of mutations). In certain embodiments, provides her...
METHODS AND MATERIALS FOR ASSESSING NUCLEIC ACIDS
- Patent #: 12553082
- Assignee: JOHNS HOPKINS UNIVERSITY
Provided herein are systems, kits, compositions and methods for sequencing library preparation and sequencing workflow (e.g., for the identification of mutations). In certain embodiments, provides her...
MicroRNA expression signature for predicting survival and metastases in hepatocellular carcinoma
- Patent #: 8252538
Provided herein are methods and compositions for the diagnosis, prognosis and treatment of Hepatocellular carcinoma (HCC). Also provided are methods of identifying anti-HCC agents.
Methods for determining heptocellular carcinoma subtype and detecting hepatic cancer stem cells
- Patent #: 8465917
The invention provides a method of determining an HCC subtype in a subject comprising a) obtaining a sample from the subject, b) assaying the sample to detect the expression of 1 or more biomarkers, a...
Key Publications
Note: This analysis includes only publications linked to NIH-funded projects and may not represent the complete body of literature in this field.
The publication evidence in this sample highlights an emerging convergence of machine learning and multi-analyte liquid biopsy approaches, with the ENCODER study demonstrating AUC values above 95% for early-onset colorectal cancer detection using an exosome-based RNA panel trained with gradient boosting models, and a parallel gastric cancer study validating a 5-exo-miRNA predictive signature via prospective trial. Methylated DNA markers appear as a particularly active area of published research, with a plasma MDM assay for recurrent metastatic breast cancer showing single-marker AUCs as high as 0.96, outperforming conventional protein biomarkers such as CA153 and CEA, which suggests epigenetic cfDNA signatures may offer superior specificity compared to legacy protein-based tests. The presence of ctDNA quality control materials characterization in JCO Precision Oncology indicates the field is beginning to address assay standardization and inter-laboratory reproducibility, a necessary precondition for regulatory approval and broad clinical adoption. Publication venues spanning Nature Biotechnology, Gastroenterology, and NPJ Precision Oncology suggest the liquid biopsy field is publishing across both high-impact general science and specialty clinical journals, reflecting a research community that spans basic discovery through clinical translation.
Must-Read Publications
1. An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study
| - Journal: Gastroenterology | Year: 2025 |
|---|
- PMID: 41364052
Why it matters: Among the linked publications, this is the most directly relevant to early cancer detection via liquid biopsy, presenting a large international multicenter study that developed and externally validated an exosome-based circulating biomarker panel for early-onset colorectal cancer with high sensitivity and specificity. The combination of machine learning, multi-country validation, and post-surgical temporal dynamics makes this a strong translational model for the field.
Key finding: A 6-biomarker exosome-based liquid biopsy achieved an AUC of 95.6% in an independent testing cohort and 97.3% sensitivity for screening-relevant stages I-III colorectal cancer in young adults.
2. A machine-learning powered liquid biopsy predicts response to paclitaxel plus ramucirumab in advanced gastric cancer: results from the prospective IVY trial
| - Journal: Molecular Cancer | Year: 2025 |
|---|
- PMID: 41316572
Why it matters: Among the linked publications, this prospective multicenter study demonstrates that exosomal microRNAs combined with machine learning can serve as non-invasive predictive biomarkers for treatment response, extending the utility of liquid biopsy beyond early detection into therapeutic decision-making. It represents a methodological advance in applying exo-miRNA profiling and machine learning to real-world clinical trial settings.
Key finding: A 5-exo-miRNA panel combined with BMI identified patients likely to respond to second-line paclitaxel plus ramucirumab therapy in advanced gastric cancer without requiring tumor tissue.
3. A machine-learning powered liquid biopsy predicts response to paclitaxel plus ramucirumab in advanced gastric cancer: results from the prospective IVY trial
| - Journal: Molecular Cancer | Year: 2025 |
|---|
- PMID: 41275215
Why it matters: Among the linked publications, this prospective multicenter study demonstrates that exosomal microRNAs combined with machine learning can serve as non-invasive predictive biomarkers for treatment response, extending the utility of liquid biopsy beyond early detection into therapeutic decision-making. It represents a methodological advance in applying exo-miRNA profiling and machine learning to real-world clinical trial settings.
Key finding: A 5-exo-miRNA panel combined with BMI identified patients likely to respond to second-line paclitaxel plus ramucirumab therapy in advanced gastric cancer without requiring tumor tissue.
4. Plasma assay of methylated DNA markers detects recurrent metastatic breast cancer
| - Journal: Npj Breast Cancer | Year: 2025 |
|---|
- PMID: 41318666
Why it matters: Among the linked publications, this study advances tumor-agnostic liquid biopsy methodology by demonstrating that a panel of methylated DNA markers in cell-free DNA can detect metastatic breast cancer recurrence without requiring patient-specific tumor tissue, offering a potentially more scalable and affordable alternative to tumor-informed ctDNA approaches. The head-to-head comparison with established protein markers highlights the superior discriminatory power of epigenetic biomarkers.
Key finding: Ten of 16 methylated DNA markers achieved single-marker AUCs above 0.90 for detecting metastatic breast cancer, outperforming traditional protein markers such as CA153 and CEA.
5. Circulating tumor cell and oncosome subtypes in portal and peripheral venous circulations may be used for diagnosis and prognostication of pancreatic cancer
| - Journal: Npj Precision Oncology | Year: 2025 |
|---|
- PMID: 41350390
Why it matters: Among the linked publications, this study addresses one of the most difficult early detection challenges in oncology - pancreatic cancer - by characterizing circulating tumor cells and oncosomes from both portal vein and peripheral blood, revealing complementary diagnostic and prognostic information from distinct anatomical compartments. This dual-compartment liquid biopsy approach provides methodological insights relevant to researchers designing multi-analyte or multi-site sampling strategies.
Key finding: Portal vein mesenchymal CTCs correlated with 1-year survival while peripheral blood oncosomes predicted poor outcomes, demonstrating that anatomical sampling site significantly impacts the diagnostic and prognostic value of liquid biopsy in pancreatic cancer.
Publication Summary
- Total linked publications: 200
- Unique journals: 10
Top Journals:
- bioRxiv : the Preprint Server for Biology (10)
- medRxiv : the Preprint Server for Health Sciences (5)
- Nature Communications (5)
- Clinical Cancer Research : an Official Journal of the American Association for Cancer Research (5)
- Npj Precision Oncology (4)
Key Organizations
| Organization | Projects | Funding | Trials | Patents |
|---|---|---|---|---|
| University of California Los Angeles | 7 | $9.5M | 0 | 0 |
| Massachusetts General Hospital | 9 | $7.5M | 0 | 0 |
| Johns Hopkins University | 6 | $6.2M | 0 | 2 |
| Beckman Research Institute/city of Hope | 3 | $3.8M | 0 | 0 |
| University of Southern California | 3 | $3.4M | 0 | 0 |
| University of Pittsburgh at Pittsburgh | 3 | $3.2M | 0 | 0 |
| Fred Hutchinson Cancer Center | 4 | $3.1M | 0 | 0 |
| Icahn School of Medicine at Mount Sinai | 2 | $2.8M | 0 | 0 |
| University of Wisconsin-Madison | 5 | $2.7M | 0 | 0 |
| Sloan-Kettering Inst Can Research | 4 | $2.6M | 0 | 0 |
| Vanderbilt University Medical Center | 2 | $2.5M | 0 | 0 |
| University of Illinois at Urbana-Champaign | 3 | $2.3M | 0 | 0 |
| Weill Medical Coll of Cornell Univ | 2 | $2.2M | 0 | 0 |
| Utah State Higher Education System--University of Utah | 2 | $2.1M | 0 | 0 |
| Stanford University | 3 | $2.0M | 0 | 0 |
Key Researchers
| Researcher | Projects | Funding | Organization |
|---|---|---|---|
| ZHOU, XIANGHONG JASMINE | 3 | $4.8M | University of California Los Angeles |
| GOEL, AJAY | 3 | $3.8M | Beckman Research Institute/city of Hope |
| WONG, DAVID T | 1 | $3.6M | University of California Los Angeles |
| KUHN, PETER | 1 | $2.8M | University of Southern California |
| TAOULI, BACHIR | 1 | $2.6M | Icahn School of Medicine at Mount Sinai |
| SUKUMAR, SARASWATI | 2 | $2.1M | Johns Hopkins University |
| VELCULESCU, VICTOR E. | 1 | $2.0M | Johns Hopkins University |
| BARRETT, MICHAEL T | 1 | $2.0M | Binary Genomics, Inc. |
| SEGAL, LEOPOLDO NICOLAS | 1 | $2.0M | New York University School of Medicine |
| GROGAN, ERIC L | 1 | $1.9M | Vanderbilt University Medical Center |
| WU, YUN | 1 | $1.9M | State University of New York at Buffalo |
| LEE, HAKHO | 1 | $1.8M | Massachusetts General Hospital |
| HERMAN, JAMES G. | 1 | $1.7M | University of Pittsburgh at Pittsburgh |
| BARTON, JENNIFER KEHLET (contact)) | 1 | $1.5M | University of Arizona |
| SKATES, STEVEN J | 2 | $1.5M | Massachusetts General Hospital |
About This Report
Methodology
This report analyzes a curated subset of NIH-funded research projects most relevant to liquid biopsy for early cancer detection. Projects were identified using semantic search (AI-based conceptual matching) and filtered by match quality.
Search Interpretation Used: Standard - "liquid biopsy and circulating tumor DNA or cell-free DNA approaches for early cancer detection and screening"
Note on Funding Figures: Per-project funding amounts shown in this report are the sum of award totals across all budget periods for each project (not just the most recent year). Funding-by-year figures show actual spend per fiscal year drawn from the underlying NIH RePORTER budget-period rows, so a multi-year project contributes to each year it received funding. The current NIH fiscal year (Oct 1 - Sep 30) is partial when this report is generated; that year is labeled "(YTD)" in tables and charts and should not be compared directly to fully-reported prior years.
Note on Funding Attribution: Clinical trials are surfaced through two paths — direct linkage to topically-relevant projects, and semantic similarity between the trial's own title and the topic (using the same vector-embedding mechanism that powers project search, gated by a dedicated trial-inclusion threshold). The second path catches trials that sit under broad institutional umbrella awards (e.g., P30 cancer center support grants, CTSA hubs) whose underlying parent grant covers many unrelated programs. Those trials are reported because their titles are clearly about the topic, but their umbrella grants' funding is not rolled into Total Committed Funding — only projects whose own abstracts clear the project-relevance threshold contribute to funding totals. This keeps the headline funding number topically attributable rather than inflated by institutional overhead grants that happen to host one relevant program among many.
Match Quality Tiers:
| Tier | Similarity | Description |
|---|---|---|
| Precise | ≥50% | Highly relevant — directly addresses the topic |
| Balanced | ≥35% | Relevant — related research with clear connection |
Sample Composition:
| Metric | Value |
|---|---|
| Projects Analyzed | 125 |
| Precise Matches | 125 |
| Balanced Matches | 0 |
| Total Committed Funding | $102.1M |
| Organizations | 66 |
| Principal Investigators | 133 |
Sample Interpretation:
- All 125 matches are Precise (similarity ≥50%). This indicates strong topical convergence — the search query maps cleanly to a well-defined research area, and confidence in sample relevance is high.
Linked Data:
| Data Type | Count | Source |
|---|---|---|
| Clinical Trials | 71 | ClinicalTrials.gov |
| Patents | 6 | USPTO |
| Publications | 200 | PubMed |
Limitations
This analysis focuses on depth over breadth, capturing publicly-funded academic research. It does not include privately-funded industry R&D or international research outside NIH grants.
Data current as of June 16, 2026.