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.
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.
You route discovery in-house and confirmatory MRD to our accredited 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.
Pharma partners often run exploratory and discovery samples in-house for speed and control, then route confirmatory or regulatory-grade MRD work to the accredited lab so the result sits inside an ISO 15189 envelope. 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.
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.
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.
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.
From protocol conversation to endpoint readout.
A typical trial engagement, from the first design call to data your biostatisticians can use.
Design call
We review your indication, endpoints and sampling schedule, and recommend an assay and delivery model before anything is committed.
Assay build
Personalised panels are designed per patient or per cohort, validated against your sample type and input requirements.
Run & monitor
Samples run in our accredited lab or on your instruments via LabSuite, with longitudinal monitoring across visits.
Data & co-publication
Go deeper, or switch to another audience.
Full-service lab or LabSuite kits.
The two delivery models, and the trade-offs on cost, control, turnaround and capability across a trial.
Publications and case studies.
Peer-reviewed performance data and the monitoring stories behind the endpoint claims.
Research & labs, or clinics.
The same five pillars retold for translational laboratories and for private oncology clinics.
Tell us about your trial.
A real human, in CET/CEST time zone, who has built ctDNA endpoints like yours.