Sample-to-Answer Cartridge Patents: Who Leads, Where the Gaps Are 2026
- 226,304 records in scope, but the ranked leaders together hold only 4.4% of them at the top five and 7.1% at the top ten — this field has no dominant gatekeeper.
- Filings peaked in 2021 at 974 and fell to 471 by 2024, a 52% drop across that three-year span; 2025-26 figures are still filling in due to publication lag and should not be read as a continued decline.
- The five most-cited records are all 1990s foundational patents on integrated nucleic acid diagnostic devices and mesoscale fluid handling — the citation base of this field is old, even though filing activity is recent.
Filing growth compares 2021 (974 records) with 2024 (471) — 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 226,304 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
Sample-to-answer cartridge design sits at the intersection of microfluidics, molecular diagnostics and consumables engineering: lysis chemistry, on-cartridge extraction, valve and pump actuation, carryover prevention, and shelf-life stability all have to work inside a single disposable part. The 226,304 records in this dataset span filings tagged against sample handling, integrated nucleic acid cartridges and centrifugal microfluidic discs, cross-referenced against contamination-control and actuation claim language. Publication lags filing by roughly 18 months, so the most recent one to two years in any trend understate real filing activity.
The picture that emerges is fragmented rather than consolidated: a broad base of diagnostics majors, instrument makers and university filers, with technology composition weighted toward material analysis and lab apparatus classes rather than the genetic-engineering classes that get more press attention.
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Filing trends and technology composition
Two views of the same 226,304-record set: how filing volume has moved year over year, and which IPC subclasses carry the claim density.
A 2021 peak, then a real decline through 2024
Filings rose from 818 in 2017 to a peak of 974 in 2021, then fell to 471 by 2024 — a 52% drop over that three-year span. Because publication trails filing by about 18 months, 2025 and 2026 figures are still incomplete and should not be read as evidence the decline continues; they simply have not finished arriving yet.
Material analysis and lab apparatus dominate, not genetics
G01N (material analysis & testing) covers 5.5% of the 226,304 records, more than double the next class, B01L (lab apparatus) at 2.2%. C12Q (enzyme/DNA measuring) and C12N (microorganisms & genetic engineering) sit lower at 1.9% and 1.1% respectively — the claim weight in this field is on the physical handling and testing apparatus, not the biochemistry, even though the search terms centre on nucleic acid workflows.
Shares are the percentage of the 226,304 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Sample-to-Answer Cartridge Design with Eureka
This page is one run against one query. Ask Eureka your own question about sample-to-answer cartridge design and every answer comes back with the patent numbers behind it.
Try EurekaThe foundational citations behind current filings
AU2020102572A4 — Method for predicting food microorganism and shelf life by dimensional analysis and PI theorem
Filed by Guizhou University, this record describes predicting food microorganism growth and shelf life using dimensional analysis and the Pi theorem: preparing and sealing a detection sample, building a growth-prediction model from dimensional analysis, running detection parameters against the sample, and feeding the resulting data back into the model to project shelf life and verify the prediction.An Australian innovation patent (petty patent), not a standard patent — narrower in scope and shorter in term, but still a citable prior-art data point for anyone claiming shelf-life prediction methods.
View full record| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US5856174A | Integrated nucleic acid diagnostic device | 1,986 |
| 2 | US5922591A | Integrated nucleic acid diagnostic device | 1,555 |
| 3 | US5578832A | Method and apparatus for imaging a sample on a device | 1,513 |
| 4 | US5304487A | Fluid handling in mesoscale analytical devices | 1,498 |
| 5 | US6143496A | Method of sampling, amplifying and quantifying segment of nucleic acid, polymerase chain reaction assembly ha… | 1,291 |
| 6 | US20020058332A1 | Microfabricated crossflow devices and methods | 1,094 |
| 7 | US4995959A | Measuring apparatus for determination of the activity or of the concentration of ions in solutions | 1,019 |
| 8 | US5635358A | Fluid handling methods for use in mesoscale analytical devices | 938 |
| 9 | US20040072278A1 | Microfluidic particle-analysis systems | 873 |
| 10 | US6043080A | Integrated nucleic acid diagnostic device | 716 |
All five of the most-cited records date to the 1990s. High citation counts inside a searched corpus reflect age and influence, not current relevance — treat this table as a map of the prior art new filings are measured against, not a ranking of what matters today.
Each row carries its publication number; clicking a row searches Eureka by that number.
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Browse MCP servers →What the numbers mean for a filing decision
Three things stand out once the ranking, the trend and the classification data are read together.
No single company controls the field
The leader holds 2,434 records and fifth place holds 1,520, yet together the top five account for only 4.4% of all records in scope, and the top ten only 7.1%. For a filer, this means freedom-to-operate risk is distributed across many mid-size portfolios rather than concentrated in one blocking estate.
Filing volume has genuinely cooled since 2021
The 974-filing peak in 2021 dropped to 471 by 2024, a complete and comparable three-year span. Several previously active assignees show 0 filings or steep year-on-year declines in the latest tracked year, consistent with a field past its filing peak rather than one still accelerating.
Claim density sits on apparatus, not biochemistry
G01N (material analysis & testing) and B01L (lab apparatus) together carry more classified weight than the DNA-specific C12Q and C12N classes. Cartridge mechanics, actuation and testing methodology are where claim space is most occupied; the biochemical assay classes are comparatively less crowded.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to sample-to-answer cartridge design, with the prior art for and against each one.
Who is filing, and who has slowed down
The ranked leaders span diagnostics majors, instrument makers and academic filers, but recent-year momentum data shows several previously active names pulling back sharply.
The largest single portfolio, still a small share of the field
The top-ranked assignee holds 2,434 records, more than any other filer, yet this is still under 1.1% of the 226,304 records in scope on its own — a reminder that leadership here means largest, not dominant.
Multiple established filers show zero activity in the latest year
Recent-year momentum data shows several previously active assignees recording 0 filings in the latest tracked year, several at -100% year-on-year. Read cautiously given publication lag, but the direction across multiple independent filers is consistent.
Co-filing is rare and concentrated in one cluster
Only 10 co-assignee pairs appear in the dataset, and the strongest links all involve the same filer paired with different named inventors — collaborative filing is the exception in this field, not the norm.
| Assignee | Recent year | YoY |
|---|---|---|
| Waters Technology Corporation | 1 | -67% |
| Becton, Dickinson and Company | 0 | -100% |
| Agilent Technologies, Inc. | 0 | -100% |
| Qiagen GmbH | 0 | -100% |
| 3M Innovative Properties Company (US) | 0 | — |
| Cepheid, Inc. | 0 | -100% |
| Genesis Pty Ltd | 0 | — |
| Shimadzu Corporation | 0 | -100% |
Where to take this
The dataset points to specific next steps depending on whether you are filing, licensing, or clearing a design.
Run a freedom-to-operate check against the cited foundational patents
The five most-cited records date to the 1990s and still anchor citation chains across current filings. Any new cartridge design should be checked against these before drafting claims.
Explore prior art in Eureka →Track momentum, not just portfolio size
Several large historical filers show sharp year-on-year declines. A shrinking-but-large portfolio is a different competitive signal than a growing small one — model both.
Set up assignee monitoring in Eureka →Probe the under-claimed sub-areas directly
Carryover barriers, valve seal design and shelf-life-stabilised reagents show thinner filing density than the core apparatus classes. A targeted search will confirm whether that gap is real or an artefact of classification.
Run a white-space search in Eureka →Common questions on this landscape
The ranking covers 100 assignees, and the leader holds 2,434 records out of 226,304 total, with fifth place at 1,520 and tenth at 1,184. Even combined, the top five account for only 4.4% of all records in scope and the top ten for 7.1%, so no single company controls the field. Diagnostics majors, instrument makers and university filers all appear in the upper ranks rather than one clear dominant player.
No — filing volume peaked in 2021 at 974 and had fallen to 471 by 2024, a 52% decline over that three-year span using the last fully comparable years. Figures for 2025 and 2026 appear lower still, but that is expected because publication lags filing by roughly 18 months, not evidence of a continued crash. Read the 2021-to-2024 comparison as the reliable trend signal, not the most recent two data points.
The relevant IPC subclasses in this dataset include G01N (material analysis & testing, 5.5% of records), B01L (lab apparatus, 2.2%), C12Q (enzyme/DNA measuring and testing, 1.9%), C12N (microorganisms & genetic engineering, 1.1%) and C12M (bioreactors & enzyme apparatus, 0.9%). A single record often carries several of these classes at once, since cartridge patents typically combine mechanical, chemical and testing claims. G01N and B01L together carry more classified weight than the DNA-specific classes, indicating claim density sits more on apparatus and testing method than on biochemistry.
AU2020102572A4 is an Australian innovation patent filed by Guizhou University covering a method for predicting food microorganism growth and shelf life using dimensional analysis and the Pi theorem, not a cartridge device itself. It is a citable prior-art data point for anyone drafting shelf-life-prediction method claims within a diagnostic cartridge context, particularly if a model-based prediction step is involved. Because it is an innovation patent rather than a standard patent, its scope and enforceable term are narrower than a standard filing, which limits how much design freedom it actually removes.
Based on this dataset's technology composition, sub-areas adjacent to the dense G01N and B01L classes carry visibly thinner filing density, including carryover-barrier design, single-use valve actuation seals, shelf-life-stabilised lysis reagent formulations and centrifugal disc pump timing mechanisms. These sit inside the searched claim space but are not where the bulk of records cluster. A targeted prior-art search in any one of these areas is the next step to confirm the gap is real rather than a classification artefact.
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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.