Technology and Science

Given the uniqueness of each tumor, a uniform testing approach may not be sensitive enough to detect cancer. For that reason we developed Simsen® Personal, a customized ctDNA test for each patient, offering next level sensitivity and specificity for monitoring cancer.

Frequently Asked Questions

What is circulating tumor DNA (ctDNA)?

Circulating tumor DNA (ctDNA) refers to small fragments of DNA that come from dead tumor cells and are found in the bloodstream. These DNA fragments circulate within the bloodstream alongside DNA from healthy cells. The ctDNA contains distinct genetic mutations or changes that are unique to the tumor they originated from.

Why use ctDNA in cancer monitoring?
ctDNA, unlike protein-based biomarkers, is a tumor-specific biomarker, indicating (true) remaining disease within the body. With the help of ctDNA, cancer can be detected years earlier, compared to using standard-of-care tools, such as imaging. Moreover, monitoring ctDNA helps understand tumor genetics, track treatment response or disease progress, and detect minimal residual disease (MRD). Analysis of ctDNA offers a non-invasive way to gather crucial information for cancer diagnosis and management.
What is the advantage of a flexible process?
Simsen® Personal delivers advanced ctDNA data for insights in clinical studies and trials. The process starts with a tumor biopsy and plasma sample, followed by Simsen Diagnostics designing a personalized assay. This flexible workflow allows testing multiple samples at different time points on the same platform, providing crucial insights over time for improved treatment assessments.
Why use ctDNA in clinical trials?
ctDNA testing offers significant advantages for clinical trials because it provides a minimally invasive way to obtain crucial information about a patient's cancer through simple blood draws. This is particularly valuable in early-stage cancer settings where traditional drug development typically requires large trials with lengthy follow-up periods. ctDNA can help identify patients who may benefit from adjuvant therapy, detect molecular residual disease, monitor treatment response, and potentially serve as an early efficacy endpoint. Early phase trials can use ctDNA changes to assess drug activity and inform future trial designs, while later phase trials can use ctDNA to enrich for high-risk populations or validate it as a predictive biomarker. This approach could ultimately lead to more efficient clinical trials and faster drug development in the curative-intent setting.
How is our test ultra-sensitive?

Because these tests are searching for specific mutations known to be present in a patient’s tumor, they can be more sensitive in detecting low levels of ctDNA. This can be particularly advantageous in early detection, minimal residual disease monitoring, or assessing response to therapy.

Our sensitivity is 0.001%.

What is the benefit of personalized tests?
Tumors are often heterogeneous, meaning they have a variety of different mutations. A fixed sequencing panel may not cover all the relevant mutations present in a particular patient’s tumor. A tumor-informed test, however, is designed based on the full spectrum of mutations in an individual’s tumor, making it more representative of the tumor and more likely to detect ctDNA.
Why are tumor-informed tests better in monitoring?
Tumors can evolve over time, especially under treatment pressure. A tumor-informed test is less biased to selection pressures whereas a fixed panel may become less relevant as the tumor evolves.
Flexible input
Can use pre-existing tumor sequencing information with no need to re-sequence tumor material only for the purpose of developing an MRD assay. Flexibility to incorporate variants from all widely used clinical genotyping assays per customer needs/wants
Customizable
Customizable solution also enables easy integration of clinically relevant mutations (e.g. PIKCA, BRAF, EGFR, etc.), including treatment resistance mutations, for maximum utility within a single assay.
Reduces noise and increases sensitivity
Our technology reduces noise and increases sensitivity using molecular barcodes.Molecular barcodes are used to track individual molecules throughout sequencing to identify and remove errors
Tumor-informed
Personalized ctDNA tests are tailored to the individual’s cancer. A sample of the patient’s tumor is used to identify unique mutations. A personalized approach enables the test to identify mutations or changes that are unique to the tumor.
WhitePaper-1

Whitepaper: Circulating tumor DNA as a biomarker in clinical trials

Reliable detection of MRD has substantial implications for clinical trial design. Identifying patients at high risk of recurrence through ctDNA testing can significantly reduce trial sample size, as enriching trials with patients likely to recur increases statistical power. Another potential role for ctDNA is as a surrogate endpoint for treatment response in settings where conventional response biomarkers are unavailable, for instance during adjuvant therapy. This could indicate treatment efficacy earlier than conventional measures such as progression-free (PFS) and overall survival (OS). These gains in trial efficiency can reduce study costs leading to expedited approval of new therapies. ctDNA-based testing also provides the opportunity to conduct trials where MRD status guides treatment. These trials could determine whether MRD-positive patients benefit from early therapeutic interventions.

Scientific publications

A list of relevant scientific publications
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Our process

Versatility and flexibility
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