FoundationOne® CDx: FDA-approved broad companion 
diagnostic for solid tumours^17,19

Comprehensive assessment in a single test

FoundationOne® CDx provides a detailed analysis of the tumour genome, analysing 324 known cancer-relevant genes across the four main classes of genomic alterations, in addition to TMB and MSI, to inform treatment decision-making.^1,7,12,13*

FoundationOne® CDx should be used proactively, at the first point of clinical uncertainty in any metastatic solid tumour

FoundationOne® CDx is a single tissue test suitable for most patients with malignant solid tumour cancers.⁷ It is most frequently used in patients with advanced, recurrent or metastatic cancers who have exhausted standard of care treatment options. A validated testing process, led by scientists and academics, produces a genomic report, typically within 14 days of receiving a suitable tumour sample. The FoundationOne® test (a prior version of FoundationOne® CDx) has been analytically validated with high sensitivity scores of 95–99% across the range of genomic alterations and a high specificity (positive predictive value >99%).¹

The Roche Foundation Medicine platform has been analytically validated

FoundationOne® CDx is based on our analytically and clinically validated comprehensive platform.¹ A practical validation strategy to determine accuracy, including sensitivity and specificity, was applied to the prior FoundationOne® platform. Results demonstrated that the platform had a test sensitivity of 95–99% across alteration types and a high specificity with a positive predictive value of more than 99%. Application of the test to 2,221 clinical cases revealed clinically actionable alterations in 76% of tumours, three times the number of actionable alterations detected by existing diagnostic tests.¹

 

What is the difference between analytical and clinical validation?

The FoundationOne® CDx report provides a clear and concise view of the important information needed to support your clinical decision-making‡

The report gives detailed information on clinically relevant alterations across 324 cancer-relevant genes to inform the use of immunotherapies, identify alternative therapy options or identify trial opportunities.⁷

The FoundationOne® CDx platform provides clear, detailed information to support confident clinical decision-making

FoundationOne® CDx may detect clinically relevant genomic alterations that common diagnostic techniques such as polymerase chain reaction (PCR) / immunohistochemistry (IHC) / fluorescence in situ hybridisation (FISH), and multigene hotspot next-generation sequencing tests may miss, which could help direct clinicians to treatment options not previously considered.^{§2,3,5,15,16}

FoundationOne® CDx is a single tissue test

The FoundationOne® CDx report delivers a complete set of results from a single test sample, thereby saving tissue.⁷

Order FoundationOne® CDx

Ordering a FoundationOne^® CDx test is simple and convenient

For more information about the ordering process, contact the Roche Foundation Medicine Customer Care Team:

Freephone: 0800 731 5711

Email: uk.foundation@roche.com

For technical and scientific enquiries related to the Foundation Medicine service, please contact the Medical Information team on:

Freephone: 0800 328 1629

Email: medinfo.uk@roche.com

 

Experience how FoundationOne® CDx can help guide personalised treatment decisions. Find out more about getting started 

 

_{*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.}

_{^†Analytical validation based on demonstrated concordance with the following companion diagnostics: cobas^® EGFR Mutation Test, Ventana ALK (D5F3) CDx Assay, Vysis ALK Break-Apart FISH Probe Kit, therascreen® KRAS RGQ PCR Kit, Dako HER2 FISH PharmDx^® Kit, cobas® BRAF V600 Mutation Test, THxID^® BRAF kit.}

_{For more information, please see the FoundationOne® CDx Technical Specifications.}

_{^‡Therapies contained in the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.}

_{^§Based on a concordance study with FoundationOne®, FoundationOne^® CDx leverages the same CGP approach and is highly concordant with FoundationOne.¹}

_{CGP: comprehensive genomic profiling; EGFR: epidermal growth factor receptor; EMA: European Medicines Agency; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MSI: microsatellite instability; NSCLC: non-small cell lung cancer; TMB: tumour mutational burden.}

^{M-GB-00001595 September 2020}