FOR HEALTHCARE PROFESSIONALS ONLY

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Our extensively validated, tissue-based comprehensive genomic profiling service for all solid tumours that helps guide efficient, personalised treatment decisions.1,2

A single, tissue- and time-saving test Delivers all insights at oncein a single test, thus saving tissue and time versus sequential biomarker testing1,2,6Supports clinical decision-makingClear, in-depth report provides insights on the genomic profile of your patient as well as associated targeted therapies, immunotherapies (ranked alphabetically within NCCN therapy categories) and relevant clinical trials5FDA
Genes and genomic signatures

Comprehensive assessment in a single test

FoundationOne CDx comprehensively examines the tumour genome, assessing the four main classes of genomic alterations in 324 known cancer-relevant genes, while also reporting TMB and MSI, which can help inform eligibility for

immunotherapies.1,2,15-23 In addition, FoundationOne CDx reports high Loss of Heterozygosity (LoH), which may reflect if a tumour is homologous recombination deficient (HRD+) and which can help inform the use of poly-ADP ribose polymerase (PARP) inhibitors.24,2S

Tumour mutational burdenBase SubstitutionsInsertions and deletionsCopy number alterationsRearrangementsMicrosatellite instabilityMSILoHTMBAnalyses324known cancer-relevant genes

Validation

Based on FDA-approved comprehensive platform

FoundationOne CDx is based on our analytically and clinically validated, FDA-approved comprehensive platform.3,4 You can be confident in the insights generated by FoundationOne CDx thanks to the review and approval of the workflow by the FDA, including analytical and clinical validation, and bioinformatics.3,4

Review and approval of the FoundationOne CDx platform workflow by the FDA

Analytical validation Clinical validation Bioinformatics




What is the difference between analytical and clinical validation?

Analytical validationClinical validationWhat does it mean?Ability to detect and measure the presence of a biomarker of interest accurately, reproducibly and reliably26,27
In-depth report

EU report includes EU-approved therapies to support clinical decision-making§5

A clear, in-depth report provides insights on your patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials.5 Approved therapies are ranked alphabetica lly with in NCCN therapy categories. The report also highlights important disease-relevant genes with no reportable alterations identified and genomic alterations associated with potential resistance to therapy to help rule out potentially ineffective treatment.5 Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.§

When using different Foundation Medicine services across the patient journey, consistency of the reports aid comparison of the results.

223156Genomic signaturesTMB and MSI status, which may help predict response to immunotherapy, as well as LoH status, which may help inform the use ofPARP inhibitorsPertinent negative resultsRules out important alterations that are not presentGene alterationsClinically relevant alterations in 324 tested cancer-related genesTherapies with clinical benefitApproved targeted therapies (ranked alphabetically within NCCN therapy categories)for the patients genomic signatures and gene alterations134Clinical trialsRelevant trials that your patient may be eligible for, based on their genomic profile and geographical locationGenomic findings with no reportable optionsTo help you rule out uncertainty and determine the most appropriate course of action564

Impact of FoundationOne CDx

Opens up treatment possibilities

FoundationOne CDx may detect clinically relevant genomic alterations missed by other tests, thereby opening up new treatment options.§6-14

Key alterations in NSCLC

PCR-based (single gene, hotspot NGS) Assesses pre-specified region6,28 Detects limited number of alterations6,28 Low sensitivity for small insertions and deletions6,29 May require supplemental FISH9,28Comprehensive genomic profiling Detects all four classes of NSCLC clinically relevant alterations1,2,32,33FISH/IHC Detects rearrangements and copy number changes6,28 May miss rearrangements not known prior to testing30,31DeletionDeletionRearrangementPoint mutationAmplificationRearrangementMETBRAFALKEGFREGFRNTRKUp to 50% missed9Up to 50% missed9Up to 50% missed935% missed3083% missed2917% missed29Up to 50% missed9Class of genetic alterationEGFRΔ exon 19(743754)EGFRΔ exon 19(753761)ALKBRAFV600EMETNTRK17%35%83%50%Up to50%Up to50%Up to50%Up to
Efficient testing

Saves tissue and time

FoundationOne CDx delivers all insights at once in a single test, saving tissue and time.