FoundationOne is driven by the knowledge of over 100 world-class experts in the field
FoundationOne is a fast and efficient tumour profiling service that can sequence hundreds of known cancer genes within 1 single assay. The genomic profiling service provided by FoundationOne is continuously optimised by world-class experts, providing the clinician with a detailed report that may assist the selection of suitable treatment plans for each individual patient, usually within 2 weeks of receipt of the sample and associated documentation.1-3
FoundationOne is validated to be used with routine clinical tissue samples, such as those obtained from biopsies. Our minimal tissue requirements help to conserve tissue and save time. FoundationOne profiling uses hybrid capture-based next-generation sequencing (NGS) technology to measure many cancer-related genes in a single assay,3 minimising the need for parallel testing. Following receipt of a sample of tumour tissue, FoundationOne uses broad NGS to interrogate more than 99% of the coding region of hundreds of known cancer-related genes, with high uniform coverage, sensitivity and specificity, identifying both common and rare alterations.4 Detection sensitivity with FoundationOne has been shown to be >99% for base substitutions, >97% for insertions and deletions, >95% for copy number alterations and >90% for rearrangements, meaning that genomic profiling with FoundationOne may identify more alterations than with many other methods of testing.3,4 Once hybrid-capture NGS has been performed:
A specialist bioinformatics team manually verifies the FoundationOne sequencing data using a proprietary customised bioinformatics and analysis pipeline, ensuring that clinically relevant alterations are reported.4
A multidisciplinary team of experts then interprets and translates these identified alterations into clinically relevant information, and annotates the genomic alterations according to current clinical and scientific evidence, incorporating the most up-to-date computational analysis.5,6
A team of medical experts then curates the report, enabling clinicians to interpret the biological and clinical relevance of the profiling results, presenting potential therapeutic options and clinical trials. Once produced, the report then undergoes review by an in-house team of board-certified oncologists or pathologists before being approved and made available online.5
The FoundationOne report then condenses this enormously complex information into a well-structured and concise report, enabling clinicians to easily and rapidly turn this information into clinical decisions.
Ordering FoundationOne can be done quickly and easily following a patient consultation
In comparison to many other traditional testing techniques, FoundationOne profiling uses NGS technology to measure over 315 cancer-related genes in a single assay, minimising the need for parallel testing.3,4 Where necessary, samples of low purity and fine-needle aspiration specimens can be used. The following are minimum tissue requirements:7
· ≥40μm tissue, 10 unstained slides or in a formalin-fixed paraffin-embedded block7
· Must have ≥20% cells of malignant origin7
· Needle biopsy is also acceptable7
· Any remaining tissue is returned to the treating physician or pathology laboratory
FoundationOne is able to process any clinical sample that meets these guidelines. Should the sample be insufficient, notification will be provided within approximately 2 days of receipt.
However, in some circumstances, if a sample does not meet our requirements, it may still be possible to attempt analysis and issue a qualified report.
What happens once my sample has been received?
Once your sample has been received and sequenced, our global team of more than 20 bioinformaticians, genomic scientists and clinicians will work to generate a curated, quality-controlled patient report. The report matches alterations to targeted therapies, immunotherapies and clinical trials for investigational therapies, utilising up-to-date scientific evidence and published clinical data. Oncologists and genomic experts are also available to answer any questions regarding the report in addition to the constant support of over 100 experts relevant to the field.
Additionally, Roche, a leading pharmaceutical company, have partnered with Foundation Medicine resulting in an even stronger network of support for patients who have been profiled using FoundationOne.
FoundationOne is supported by one of the world’s most comprehensive databases, FoundationCORETM
FoundationCORE, one of the world’s most comprehensive cancer genomic databases, is a growing system containing over 150,000 patients’ tumour profiles.8 Analysis of this large proprietary database enables us to identify and flag both common and rare alterations within a tumour sample and match potential therapeutic options for that patient.4,9
Following identification of new alterations, the FoundationCORE database is quickly updated so that all future patients can benefit from this knowledge. Our approach ensures that we maximise the chance of matching potentially beneficial therapies and open enrolling clinical trials for investigational therapies to patients’ individual tumour profiles.10
Additionally, each patient’s individual report contributes to the overall success of profiling and the treatment of future patients. Upon identification of an alteration within a patient’s sample, the results become incorporated into the system. These results may then be of great benefit in the identification of suitable treatment regimens for future patients.10
FoundationOne sample report
The FoundationOne report details relevant patient information, including date of receipt of specimen and report production date. It provides both a top-line overview and a detailed description of any alterations that have been identified, how many therapies have been identified that are associated with a potential clinical benefit and lack of response, details of therapies approved in another tumour type that may be beneficial based on the patient alterations and any potentially beneficial open enrolling clinical trials for investigational therapies.
- Roche Foundation Medicine data on file: Strategy internal presentation.
- Roche Foundation Medicine data on file.
- FoundationOne technical information.
- Frampton, G.M. et al. Nat Biotechnol 2013; 31:1023–1031.
- FMI data on file. Lab processes: deep dive. Internal presentation.
- FMI data on file. Clinical Genomics & Medical Reporting: Creating a Patient Report. Internal presentation.
- FoundationOne specimen guidelines
- Genomeweb. Foundation Medicine Q3 revenues up 45 percent. Available at: https://www.genomeweb.com/molecular-diagnostics/foundation-medicine-q3-revenues-45-percent [accessed November 2017].
- FoundationCORE press release, June 2016. Available at: http://investors.foundationmedicine.com/releasedetail.cfm?releaseid=977617 (accessed November 2017).