---
title: ctDNA for Clinical Trials | Custom assays and MRD
description: Power your trial with sensitive, custom ctDNA assays for MRD and treatment monitoring. Simsen designs, runs and scales detection around your protocol.
image: https://simsendiagnostics.com/hubfs/simsen-og-clinical-trials.png
---

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    - [Our technology](https://simsendiagnostics.com/platform-our-technology)
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- [EVIDENCE](https://simsendiagnostics.com/evidence-hub) 
    - [Publications](https://simsendiagnostics.com/evidence-publications)
    - [Paediatric solid tumours](https://simsendiagnostics.com/evidence-paediatric-solid-tumours)
    - [CNS tumours & CSF ctDNA](https://simsendiagnostics.com/evidence-cns-csf-ctdna)
    - [White papers](https://simsendiagnostics.com/evidence-white-paper-ctdna-trials)
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    - [About us](https://simsendiagnostics.com/company-about)
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    - [Sample collection guides](https://simsendiagnostics.com/resources-sample-collection-guides)
    - [Baseline kit guide](https://simsendiagnostics.com/baseline-collection-kit)
    - [Follow-up kit guide](https://simsendiagnostics.com/resources-followup-collection-kit)

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- [PLATFORM](https://simsendiagnostics.com/platform) 
    - [Why Simsen](https://simsendiagnostics.com/why-simsen)
    - [Our technology](https://simsendiagnostics.com/platform-our-technology)
    - [Methodology](https://simsendiagnostics.com/platform-methodology) 
          - [Find your approach](https://simsendiagnostics.com/find-your-approach)
    - [Delivered your way](https://simsendiagnostics.com/both-delivery-models)
- [Solutions](https://simsendiagnostics.com/solutions-overview)
- [EVIDENCE](https://simsendiagnostics.com/evidence-hub) 
    - [Publications](https://simsendiagnostics.com/evidence-publications)
    - [Paediatric solid tumours](https://simsendiagnostics.com/evidence-paediatric-solid-tumours)
    - [CNS tumours & CSF ctDNA](https://simsendiagnostics.com/evidence-cns-csf-ctdna)
    - [White papers](https://simsendiagnostics.com/evidence-white-paper-ctdna-trials)
- [COMPANY](https://simsendiagnostics.com/company-about) 
    - [About us](https://simsendiagnostics.com/company-about)
    - [Team](https://simsendiagnostics.com/company-team)
    - [Contact us](https://simsendiagnostics.com/company-contact)
    - [News](https://simsendiagnostics.com/news)
- [RESOURCES](https://simsendiagnostics.com/resources-hub) 
    - [Sample collection guides](https://simsendiagnostics.com/resources-sample-collection-guides)
    - [Baseline kit guide](https://simsendiagnostics.com/baseline-collection-kit)
    - [Follow-up kit guide](https://simsendiagnostics.com/resources-followup-collection-kit)

[For clinical trials Pharma and CROs Validate MRD endpoints, cut trial-arm cost, build EU regulatory readiness. Design a trial assay →](https://simsendiagnostics.com/solutions-trials)

[For research and labs Translational oncology See signal in paediatric and early-stage samples your current platform misses. Send samples or run SiMSen-Seq in-house. See the signal →](https://simsendiagnostics.com/solutions-research?hsLang=en)

[For clinics Premium oncology monitoring Detect minimal residual disease ahead of imaging. Logistics across the EU, UK and EEA. Detect relapse earlier →](https://simsendiagnostics.com/solutions-clinic?hsLang=en)

[Home](https://simsendiagnostics.com?hsLang=en) / [Solutions](https://simsendiagnostics.com/solutions-overview?hsLang=en) / For clinical trials

For clinical trials

# The *evidence is yours*. Endpoints you can defend.

Ultra-sensitive, tumour-informed ctDNA endpoints for European oncology trials, with raw data access and co-publication built in.

~0.001%

Panel-level MRD sensitivity (VAF), the regime where most platforms return false negatives.

9 months

Lead time over imaging demonstrated in a published paediatric monitoring study

EU

Quality system compliant with ISO 15189 and ISO 9001; accreditation in progress, GDPR-native, samples never leave the European Union

[Endpoint power](https://simsendiagnostics.com/solutions-trials#endpoint_01) [Flexible delivery](https://simsendiagnostics.com/solutions-trials#flexible_02) [Decision grade data](https://simsendiagnostics.com/solutions-trials#decision_03) [Auditable pipeline](https://simsendiagnostics.com/solutions-trials#auditable_04) [Co-publication](https://simsendiagnostics.com/solutions-trials#copublication_05)

01

Endpoint power

### You power your trial on signal others cannot resolve, and shrink the cohort it takes to read out.

**Tracking 20 to 30 variants, SiMSen-Seq reaches MRD sensitivity around 0.001% VAF, so an MRD endpoint reaches significance on earlier, smaller signal. That is fewer patients to a readable result, and a faster path to a go or no-go.**

When the surrogate endpoint moves months before imaging does, adaptive designs get the evidence to drop a losing arm sooner. The cost saving is not a discount on a per-sample price; it is arm-level, from running a tighter, faster trial.

For early-phase work with low tumour burden, the sensitivity floor is also what determines whether ctDNA is usable as an endpoint at all.

02

Flexible delivery

### You route discovery in-house and confirmatory MRD to our lab, on the same chemistry.

**Two delivery models, one assay. Run SiMSen-Seq on your own instruments with LabSuite, send samples to the Simsen lab, or do both across the trial lifecycle.**

The choice is operational, not scientific: the chemistry, sensitivity and data quality are identical either way.

It also means a multi-site trial can standardise on one method without forcing every site through one central lab.

03

Decision grade data

### You get variant-level evolution and resistance tracking, not just a binary endpoint flag.

**Personalised panels surface clonal dynamics and resistance markers over time, so the trial answers mechanism questions, not only the primary endpoint.**

For a sponsor, that is biomarker and resistance evidence accruing alongside the efficacy readout, the kind that supports the next protocol, the label conversation and the publication. Each variant carries a clinical rationale your medical and biomarker teams can defend.

If a regulator or a reviewer asks why a patient was scored positive, there is an answer beyond a score.

04

Auditable pipeline

### Your analytics team gets full raw data and an open pipeline they can audit and reproduce.

**No black-box scoring. Raw BAM and FASTQ delivered with every analysis, documented methods, open to independent reanalysis by your team or a third party.**

For a regulated submission, reproducibility is not a nice-to-have. You need to re-run the call, validate it against a second pipeline, and stand behind the method in front of an authority without a vendor sitting between you and the data.

We work that way by default, and we get told when our pipeline is wrong. We prefer that to the alternative.

05

Co-publication

### You work with a specialist team on protocol design, interpretation and the resulting paper.

**A small team of ctDNA specialists in your time zone, who have already run trials like yours, engaged from protocol design through to co-authorship.**

An early conversation on assay and sampling design can save a sample run, and an underpowered endpoint, later. Co-authorship where the science supports it. Interpretation help when a result is unusual and you want a second set of eyes before it reaches a steering committee.

We are not the right partner for every trial. We are an exceptionally good partner for the ones we are right for.

HOW IT Works

## From protocol conversation to endpoint readout.

A typical trial engagement, from the first design call to data your biostatisticians can use.

STEP 01

### Design call

We review your indication, endpoints and sampling schedule, and recommend an assay and delivery model before anything is committed.

Step 02

### Assay build

Personalised panels are designed per patient or per cohort, validated against your sample type and input requirements.

STEP 03

### Run & monitor

Samples run in our lab or on your instruments via LabSuite, with longitudinal monitoring across visits.

STEP 04

### Data & co-publication

Raw data and decision-grade reports delivered to your analytics team, with co-authorship where the science supports it.

WHERE TO GO NEXT

## Go deeper, or switch to another audience.

Delivery

### Full-service lab or LabSuite kits.

The two delivery models, and the trade-offs on cost, control, turnaround and capability across a trial.

[See both delivery models →](https://simsendiagnostics.com/both-delivery-models?hsLang=en)

Evidence

### Publications and case studies.

Peer-reviewed performance data and the monitoring stories behind the endpoint claims.

[Read the evidence →](https://simsendiagnostics.com/evidence-publications?hsLang=en)

Other audiences

### Research & labs, or clinics.

The same five pillars retold for translational laboratories and for private oncology clinics.

[Back to solutions →](https://simsendiagnostics.com/solutions-overview?hsLang=en)

Talk to us

### Tell us about your trial.

A real human, in CET/CEST time zone, who has built ctDNA endpoints like yours.

[inbox@simsendiagnostics.com →](mailto:inbox@simsendiagnostics.com) [Request a conversation →](https://simsendiagnostics.com/start-a-conversation?hsLang=en)

 

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**Visiting and postal address:**  
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431 53 Mölndal, Sweden

**Shipping address:**  
c/o AstraZeneca R&D Mölndal  
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PLATFORM

PLATFORM

- [Platform overview](https://simsendiagnostics.com/platform)
- [Why Simsen](https://simsendiagnostics.com/why-simsen)
- [Our technology](https://simsendiagnostics.com/platform-our-technology)
- [Delivered your way](https://simsendiagnostics.com/both-delivery-models)

SOLUTIONS

SOLUTIONS

- [For clinical trials](https://simsendiagnostics.com/solutions-trials)
- [For research and labs](https://simsendiagnostics.com/solutions-research)
- [For clinics](https://simsendiagnostics.com/solutions-clinic)
- [Solutions overview](https://simsendiagnostics.com/solutions-overview)

COMPANY

COMPANY

- [About](https://simsendiagnostics.com/company-about)
- [News](https://simsendiagnostics.com/news)
- [Team](https://simsendiagnostics.com/company-team)
- [Contact](https://simsendiagnostics.com/company-contact)

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