ctDNA Quantification Patents: Leaders, Trends & White Space 2026
- 35.1% concentration. The top 5 assignees hold 1,802 of the 5,131 records in scope — a concentrated core sitting above a long tail of single- and few-filing entrants.
- Filing has plateaued, not collapsed. Volume moved from 614 records in 2021 to 565 in 2024, an 8% pullback across the only fully-published years — a mature but still active field, not a shrinking one.
- Bioinformatics is now core claim territory. G16B (bioinformatics) appears on 37.1% of records, second only to C12Q's 75.1%, showing algorithmic tumour-fraction calling is as contested as the wet-lab chemistry.
Filing growth compares 2021 (614 records) with 2024 (565) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field. Top-5 share is the combined record count of the five largest assignees divided by all 5,131 records in scope (CR5), not by the ranked leaders only.
What the ctDNA quantification patent record shows
Circulating tumour DNA (ctDNA) quantification sits at the intersection of nucleic acid chemistry and computational calling: recovering a faint tumour signal from a background of normal cell-free DNA, then converting that signal into a usable tumour fraction. The 5,131 records in scope span preanalytical handling (tube stabilisation, extraction yield), assay chemistry (fragment size selection, background noise suppression) and informatics (tumour fraction estimation, clinical sensitivity thresholds). The search string was built to capture this full chain rather than any single step, which is why bioinformatics-heavy filers sit alongside wet-lab reagent specialists in the same ranking.
Filing activity peaked in 2021 at 614 records and has since eased to 565 in 2024 — the last year with a complete publication record — an 8% decline that reads as consolidation around established methods rather than retreat. Because publication lags filing by roughly 18 months, 2025 and 2026 figures will continue to fill in and should not yet be read as a downturn.
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Filing trend and technology composition
Two views of the same 5,131-record dataset: the year-by-year filing curve, and the IPC subclasses those records fall under. Because a single record can carry several IPC codes, the composition shares sum to well over 100% of the record total.
Filing trend, 2017–2026
Records rose from 295 in 2017 to a peak of 614 in 2021, then eased to 565 by 2024 — an 8% pullback over that span. 2025 and 2026 are still under-counted due to publication lag and should not be read as a fall-off.
Technology composition by IPC subclass
C12Q (enzyme/DNA measuring and testing) anchors 75.1% of records, with G16B (bioinformatics) on 37.1% — evidence that tumour-fraction calling algorithms are claimed almost as heavily as the underlying assay chemistry. G01N, G16H, C12N, G06F, G06N and A61K each cover a smaller but still material share, pointing to instrumentation, clinical software, genetic engineering, general computing, AI models and therapeutic tie-ins as secondary but active claim zones.
Shares are the percentage of the 5,131 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Circulating Tumour DNA Quantification with Eureka
This page is one run against one query. Ask Eureka your own question about circulating tumour dna quantification and every answer comes back with the patent numbers behind it.
Try EurekaMost-cited records and a recent representative filing
Liquid biopsy assay for genomic profiling of circulating tumor DNA (US20260103759A1)
An assay provides comprehensive genomic profiling for plasma-derived circulating tumor DNA from solid tumors. It covers genes for mutations including single nucleotide variants, insertions and deletions, copy number variants, and fusions, plus microsatellite instability status, using a custom hybrid capture process with optimized chemistry and panel design alongside novel algorithms for SNV, indel, and CNV data filtering.Filed by BillionToOne, Inc. and published 2026-04-16, this record illustrates how recent filings bundle wet-lab panel design with downstream filtering algorithms into a single claim set.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US20160032396A1 | Identification and Use of Circulating Nucleic Acid Tumor Markers | 480 |
| 2 | US20100105049A1 | Processes and compositions for methylation-based enrichment of fetal nucleic acid from a maternal sample usef… | 447 |
| 3 | US20080020390A1 | Detecting fetal chromosomal abnormalities using tandem single nucleotide polymorphisms | 397 |
| 4 | WO2014151117A1 | Identification and use of circulating nucleic acid tumor markers | 372 |
| 5 | US20110288780A1 | Methods for Non-Invasive Prenatal Ploidy Calling | 339 |
| 6 | US20130085681A1 | Methods and processes for non-invasive assessment of genetic variations | 323 |
| 7 | WO2010033639A2 | Processes and compositions for methylation-based enrichment of fetal nucleic acid from a maternal sample usef… | 308 |
| 8 | US20150376700A1 | Analysis of nucleic acid sequences | 289 |
| 9 | WO2016130704A2 | Methods and compositions for analyzing cellular components | 285 |
| 10 | US20130123120A1 | Highly Multiplex PCR Methods and Compositions | 282 |
Citation counts favour older records simply because they have had more time to accumulate citations within the searched corpus — treat this as a signal of influence on the field's foundational methods, not of current commercial importance.
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Read together, the concentration, trend and IPC data point to a field where the foundational chemistry is well-claimed but the computational layer is still being actively contested.
The core is crowded, the tail is not
With 1,802 of 5,131 records held by the five leading assignees, core tumour-fraction detection methods and preanalytical stabilisation claims are densely occupied. Below that line, the tail of the ranked 100 companies thins quickly toward single-digit filing counts, which is where narrower mechanistic claims still have room.
A plateau, not a decline
Filing volume eased modestly from its 2021 peak through the last fully-published year. Given the 18-month publication lag, 2025-2026 figures are still incomplete and should not be read as an accelerating slowdown.
Algorithms are now first-class claim subject matter
More than a third of records touch bioinformatics classification alongside the 75.1% carrying C12Q wet-lab measurement claims. Tumour-fraction calling, noise modelling and sensitivity thresholding are being claimed computationally as often as chemically.
A small number of tight collaborations anchor the field
Only 10 co-assignee pairs appear in the dataset, but the strongest pair co-files 70 times — evidence of a few deep, long-running institutional partnerships rather than broad industry-wide co-development.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to circulating tumour dna quantification, with the prior art for and against each one.
Leading assignees and where new entrants can still stake claims
The ranked leaders account for half the field's activity, but recent-year momentum has slowed sharply even among them — a sign that the next filing wave will need to move into less-claimed sub-areas rather than repeat the founders' core claims.
Ten assignees, half the field
The top 10 combined account for 2,600 of the 5,131 records in scope. That leaves the remaining 90 ranked companies, plus everyone outside the ranking, competing for the other half across a much wider set of narrower claims.
Even the leader is filing less this year
The top-ranked assignee dropped to 19 records in the latest year, a 74% year-on-year decline, and other leading filers show comparable pullbacks. This tracks the general publication-lag pattern for the most recent year rather than a genuine collapse in R&D activity.
Foundational prenatal-diagnostics IP still anchors the field
Several of the most-cited records originate from non-invasive prenatal testing methods later repurposed for tumour detection, underlining how ctDNA quantification inherited its core chemistry from an adjacent diagnostic field.
| Assignee | Recent year | YoY |
|---|---|---|
| Guardant Health, Inc. | 19 | -74% |
| Natera, Inc. | 5 | -80% |
| GRAIL, Inc. | 4 | -69% |
| Freenome Holdings, Inc. | 2 | -75% |
| The Chinese University of Hong Kong | 1 | -75% |
| Foundation Medicine, Inc. | 1 | -96% |
| The Board of Trustees of the Leland Stanford Junior University | 1 | -83% |
| Sequenom, Inc. | 0 | -100% |
Where to take this analysis
The figures here describe the shape of the field; deciding where to file, license or design around requires drilling into specific claim sets.
Map claim scope against your assay design
Run your specific fragment size selection, extraction yield or tumour fraction calling method against the dense C12Q and G16B claim clusters identified above.
Explore this landscape in EurekaTrack the leading assignees' next moves
Filing momentum has slowed across the top-ranked companies this year; monitoring their next filings will show whether that is publication lag or a genuine strategic shift.
Set up assignee tracking in EurekaScreen the white space chips before drafting
The under-claimed sub-areas flagged here are starting points, not conclusions — validate freedom-to-operate against the full claim text before committing to a filing strategy.
Run a white space search in EurekaCommon questions on ctDNA quantification patents
The dataset's assignee ranking covers 100 companies, with the leader holding 441 records out of 5,131 in scope. The top 5 combined account for 1,802 records (35.1% of all records), and the top 10 combined account for 2,600 records (50.7%). That leaves a long tail of the remaining ranked companies and unranked filers splitting the other half, so the field is concentrated at the top but not monopolised.
Filing volume rose from 295 records in 2017 to a peak of 614 in 2021, then eased to 565 by 2024, an 8% decline over that span using the last fully-published years. Publication typically lags filing by about 18 months, so the lower counts showing for 2025 and 2026 are an artefact of that lag rather than evidence of a real slowdown. Read the trend as a plateau after a strong early-2020s expansion, not a field in decline.
C12Q (measuring and testing involving enzymes and DNA) appears on 75.1% of the 5,131 records, making wet-lab detection chemistry the largest single category. G16B (bioinformatics) follows at 37.1%, showing that tumour-fraction calling and noise-filtering algorithms are claimed almost as heavily as the underlying assay steps. Smaller but still active categories include G01N material analysis (15.5%), G16H healthcare informatics (12.7%) and C12N genetic engineering (10.4%), reflecting instrumentation, clinical software and molecular biology claims layered around the core detection methods.
US20260103759A1, filed by BillionToOne, covers a liquid biopsy assay bundling comprehensive genomic profiling — SNVs, indels, copy number variants, fusions and microsatellite instability status — with a custom hybrid capture process and proprietary data-filtering algorithms for a plasma-derived ctDNA panel. Anyone building a similarly broad panel that combines multi-variant calling with a hybrid capture chemistry and bespoke filtering logic should review this filing's specific claim language closely. It exemplifies a broader pattern in the recent filing set: bundling wet-lab panel design and computational filtering into a single claim family rather than filing them separately.
The concentration and IPC data point to several under-claimed pockets: fragment size selection tuned specifically for low tumour-fraction samples, background noise suppression algorithms, preanalytical tube stabilisation chemistry, clinical sensitivity threshold calibration, and AI-based tumour fraction estimation models. These sit below the dense core claim space occupied by the leading assignees' foundational detection and enrichment methods. Any of these branches would need a freedom-to-operate check against the specific claim sets of the top-ranked filers before drafting, since density in the surrounding IPC classes suggests adjacent claims may already partially cover them.
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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.
Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.