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FoundationOne® CDx: FDA-approved broad companion diagnostic for solid tumours1


FoundationOne® CDx is a next-generation sequencing-based diagnostic test, which should be used to inform the use of targetted therapies, immunotherapies, identify alternative options or identify trial opportunities.2–8

What is FoundationOne® CDx?

Analytically v alid a t ed† P o t entially e xpands t r e a tment options A single t i s s u e - s a v i n g t e s t Supports clinical decision-making 3 2 4 genes, TMB and MSI D e m o n s t r a t e d s p e c i fi c i t y ( > 9 9 % ) a n d s e n s i t i v i t y ( 9 5 9 9 % ) w h e n a s s e s s i n g f o r m a l i n - fi x e d p a r a ffi n - e m b e d d e d ( F F P E ) c a n c e r s p e c i m e n s c o m p a r e d w i t h c u r r e n t d i a g n o s t i c t e s t s 2 E x p e r t s a n a l y s e t h e d a t a a n d p r o v i d e a c l e a r , d e t a i l e d r e p o r t t o s u m m a r i s e i n s i g h t s o n t h e g e n o m i c p r o fi l e o f y o u r p a t i e n t , a n d l i n k t h e s e t o a s s o c i a t e d t a r g e t e d t h e r a p i e s , i m m u n o t h e r a p i e s a n d r e l e v a n t c l i n i c a l t r i a l s 2,3 T h e r e p o r t p r o v i d e s c l e a r d e t a i l e d i n f o r m a t i o n t o i n f o r m t r e a t m e n t d e c i s i o n - m a k i n g a n d m a y i n c l u d e t h e r a p i e s t h a t a r e a p p r o v e d b y t h e E u r o p e a n M e d i c i n e s A g e n c y ( E M A ) f o r a l t e r a t i o n s i d e n t i fi e d i n a n i n d i v i d u a l p a t i e n t s t u m o u r 2,3 P o t e n t i a l l y e x p a n d s y o u r p a t i e n t s t r e a t m e n t o p t i o n s 2–7 9-13 C o m p r e h e n s i v e r e s u l t s a n d d e t a i l e d i n s i g h t s d e l i v e r e d v i a a s i n g l e t e s t 9 Detailed r eport I n f o r m s t h e u s e o f i m m t a r g e t t e d t h e r a p i e s , u n o t h e r a p i e s , i d e n t i fi e s a l t e r n a t i v e t h e r a p y o p t i o n s a n d i d e n t i fi e s t r i a l o p p o r t u n i t i e s A n a l y s e s 3 2 4 k n o w n c a n c e r - r e l e v a n t g e n e s , a c r o s s t h e f o u r m a i n c l a s s e s o f g e n o m i c a l t e r a t i o n s * , i n a d d i t i o n t o t u m o u r m u t a t i o n a l b u r d e n ( T M B ) a n d m i c r o s a t e l l i t e i n s t a b i l i t y (MSI) 9
Genes and biomarkers

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.2,9,14,15

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.9 It is most frequently used in patients with advanced, recurrent or metastatic cancers who have exhausted standard of care treatment options.2,3,9 A validated testing process, led by scientists and academics, produces a genomic report, typically within 14 days of receiving a suitable tumour sample.2,3 The FoundationOne® test and FoundationOne® CDx have been analytically validated with high sensitivity scores of 95–99% across the range of genomic alterations and a high specificity (positive predictive value >99%).2,3
MSI TMB Base substitutions Insertions and deletions Copy number alterations Tumour mutational burden Microsatellite instability Rearrangements Analyses 324 known cancer-relevant genes

The Roche Foundation Medicine platform has been analytically validated

FoundationOne® CDx is based on our analytically and clinically validated comprehensive platform.2,3 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.2


What is the difference between analytical and clinical validation?

17 2 , 4 , 7 , 9 17 2 , 4 , 7 , 9
In-depth Report

The FoundationOne® CDx report provides a clear and concise view of the important information needed to support your clinical decision-making4,10‡

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.4

Novel Insights

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.||1,4,5,7,18
7 9 , 2 0
Efficient Testing

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.2,3
F o u n d a t i o n O n e ® C D x S i n g l e b i o m a r k e r t e s t i n g

Order FoundationOne® CDx

Ordering a FoundationOne® CDx test is simple and convenient

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

Freephone: 0800 731 5711

Email: uk.foundation@roche.com

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

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 and 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 and THxID® BRAF kit, FoundationFocus CDx BRCA.1

‡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.2

ALK: Anaplastic lymphoma kinase; CGP: comprehensive genomic profiling; EGFR: epidermal growth factor receptor; EMA: European Medicines Agency; FFPE: formalin-fixed paraffin-embedded; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MSI: microsatellite instability; NCCN: National Comprehensive Cancer Network; NSCLC: non-small cell lung cancer; PCR: polymerase chain reaction; TMB: tumour mutational burden.


M-GB-00009114 April 2023


  1. Food and Drug Administration. List of cleared or approved companion diagnostic devices. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.
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  9. FoundationOne® CDx Technical Specifications.
  10. Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–68.
  11. Schwaederle M, et al. Mol Cancer Ther. 2016;15:743–52.
  12. Wheler JJ, et al. Cancer Res. 2016;76:3690–701.
  13. Dhir M, et al. Cancer Med. 2017;6:195–206.
  14. Chalmers ZR, et al. Genome Med. 2017;9:34.
  15. Dudley JC, et al. Clin Cancer Res. 2016;22:813–20.
  16. Next Steps: Ordering FoundationOne® CDx / FoundationOne® Heme.
  17. Masucci GV, et al. J Immunother Cancer. 2016;4:76.
  18. Ali SM, et al. Oncologist. 2016;6:762–70.
  19. Schrock AB, et al. Clin Cancer Res. 2016;22:3281–5.
  20. FoundationOne® CDx Gene List.
  21. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC (Version 4.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 14, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 2022. Available at www.NCCN.org.