Simsen Diagnostics

Most labs that want to run ctDNA can already do the wet lab. The wall they hit is the bioinformatics. Preparing libraries and loading a sequencer is the familiar part. Calling a real mutation from background noise at parts-per-million, with proper error correction, without turning clonal haematopoiesis into a confident false positive, is specialist analytical work that few groups have on staff. That gap is why so many capable wet-lab teams still send ctDNA out. LabSuite closes it. The error-corrected analysis ships with the chemistry and the panel, as integrated software your team runs in-house, and the raw BAM and FASTQ stay open so your own bioinformaticians can audit every call. The hard part solved, and still transparent. For groups weighing up in-house ctDNA: is your tightest constraint the wet lab, the bioinformatics, or the validation? #ctDNA #NGS #Bioinformatics #TranslationalResearch #LiquidBiopsy

Does clearing ctDNA actually mean the patient does better? In one trial, yes, and it beat the protein markers. In the PEMDAC phase 2 trial, ctDNA clearance predicted overall survival and outperformed established protein markers as a readout (Ny et al., Nature Communications, 2021). That is the case for building a tumour-informed ctDNA endpoint into a trial. It tracks the patient's own mutations, and the dynamics can carry real prognostic weight, not just confirm what imaging already shows. It is one trial in one setting, so please treat it as evidence of what is possible rather than a universal claim. But it is indeed the kind of result that moves ctDNA from interesting to useful in a protocol. For clinical development teams: would a molecular endpoint like this earn a place in your next study, yes or not yet? #ClinicalTrials #ctDNA #Biomarkers #DrugDevelopment #PrecisionOncology

Paediatric solid tumours You cannot take a large blood draw from a child. That single fact is why paediatric solid tumours are one of the hardest places to find circulating tumour DNA. Small blood volume, low tumour burden, and allele frequencies where most monitoring assays start returning false negatives. The biology that makes these cancers urgent is the same biology that hides them. That is the regime we built SiMSen-Seq for. It works from 10 to 50 ng of cfDNA and tracks a panel of the patient's own variants, typically 20 to 30 and up to 50, so it runs on the sample a child can actually give. In published neuroblastoma monitoring, ctDNA flagged relapse around nine months before clinical relapse (Ek et al., Cancer Research Communications, 2024). Lead time depends on tumour type, shedding and sampling schedule, so we treat that as evidence of what is possible, not a promise for every case. If you work on a paediatric cohort, what is your biggest constraint right now: sample volume, sensitivity, or panel design? #ctDNA #PediatricOncology #Neuroblastoma #LiquidBiopsy #PrecisionOncology

A smaller trial is not a compromise. Done right, it is a better trial. Early-phase solid-tumour trials give you the least to work with: low tumour burden, small cohorts, allele frequencies where most assays miss. The instinct is to enrol more patients. The smarter move is often to enrol the right ones. When you enrich for ctDNA-positive patients with a sufficiently sensitive endpoint, you can power the study on a fraction of the cohort. In our worked example, that was roughly an eight-fold cut in enrolment and about a quarter of the per-patient cost. Faster read-outs, lower burn, and a losing arm you can drop sooner. For trial leads: the biggest barrier to ctDNA enrichment in your next protocol, is it sensitivity, cost, or regulatory comfort? #ClinicalTrials #ctDNA #DrugDevelopment #MRD

We detected relapse nine months before imaging did. That was paediatric neuroblastoma monitoring, and nine months is not a rounding error. It is time to act while there are still options. The same pattern shows up elsewhere. In ctDNA-monitored metastatic breast cancer, 68% of surveillance scans could have been avoided (Mouhanna et al., 2025). Fewer scans, less anxiety, earlier signal. This is what tumour-informed ctDNA monitoring is for: catching minimal residual disease ahead of the scan, not confirming it afterwards. For clinicians here: if you could see recurrence months earlier, would that change your follow-up schedule, or would you still scan on the same clock? #MinimalResidualDisease #PrecisionMedicine #Oncology