Thank you. Your Insight Genomics discovery call has been booked. We look forward to meeting you.
On the call we’ll help you to:
- understand genomic profiling and when it might be an option for you.
- understand what RareCan Insight genomic tests are and how they apply to your cancer diagnosis and clinical trials in general.
- make a decision about whether it’s the right time to go ahead with one of our genomic tests.
About our clinically validated cancer biomarkers
Circulating Tumour DNA (ctDNA)
The extraction of ctDNA from a simple blood sample is recognised by international clinical guidelines, including ESMO’s recommendations for advanced cancer, as a valid method to identify actionable mutations and direct targeted therapies without the need for invasive surgery.
Tumour Mutational Burden (TMB)
Tumour Mutation Burden (TMB) measures the total number of mutations present in your cancer cells. Massive pan-tumour studies have shown that a high mutational burden is extensively linked to improved responses to modern immunotherapies across a wide range of solid tumours.
Microsatellite Instability (MSI)
Microsatellite Instability (MSI) is a critical feature of how DNA repairs itself. Peer-reviewed research establishes MSI as a predictive biomarker for cancer immunotherapy, helping oncologists understand if your immune system can be effectively stimulated to attack the tumour.
Tumour Fraction (TFx) Estimates
Your report includes a Tumour Fraction estimate, which calculates the proportion of the cell-free DNA isolated in your blood sample that is tumour DNA. Accurately measuring this is emerging as a powerful non-invasive biomarker to assess overall tumour burden and monitor disease progression.
About our tests
- Our liquid biopsy tests work by analysing cell-free DNA (cfDNA) circulating in your blood to identify and characterise tumour-derived fragments (circulating tumour DNA, or ctDNA).
- Our tissue-based tests work by analysing tumour DNA from samples stored by your hospital following biopsy or surgery.
- The tests use Next Generation Sequencing (NGS) on high throughput Illumina platforms to provide a genomic profile of your cancer.
- Our tests are extensively validated, accredited by the American College of Pathologists (CAP) and performed in an ISO 15198 accredited laboratory.
- Analysis and reporting is undertaken as per international guidelines (ACMG/AMP/ASCO/CAP) using a CE-IVD certified mutation database for variant interpretation and reporting.
- The output from the cancer genetic testing is a report highlighting genetic variants found, providing information for clinicians on the potential relevance of any variants, and listing out clinical trials that might be treatment options based on the genomic profile of your cancer.
Regulatory information / disclaimer
- RareCan Insight genomic tests are registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as Class 1 in vitro diagnostic medical devices.
- They are intended for use by healthcare professionals for the qualitative identification of specific somatic variants in circulating tumour DNA (ctDNA) extracted from human whole blood or tumour DNA (tDNA) extracted from tumour tissue samples.
- The tests are intended to support clinicians in identifying potential clinical trials for which you may be eligible.
- The sample collection kits are intended for use by qualified phlebotomists and are not intended for patient self-testing or self-sampling.
- Results must be interpreted by a qualified healthcare professional in conjunction with your full clinical history, other diagnostic test results, and relevant clinical guidelines.
- The results are not intended to be used as the sole basis for treatment decisions, and further confirmatory testing may be required.
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