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FoundationOne® CDx: FDA-approved broad companion 
diagnostic for solid tumours17,19


FoundationOne® CDx is a next-generation sequencing-based diagnostic test, which should be used to inform the use of immunotherapies, identify alternative options or identify trial opportunities.1–6

What is FoundationOne® CDx?

Analytically v alid a t ed† P o t entially e xpands t r e a tment options A single tissue-saving test Supports clinical decision-making 3 2 4 genes, TMB and MSI 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 ( M S I ) 7 * 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 1 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 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 7 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 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 § 1 6 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 7 Detailed r eport I n f o r m s t h e u s e o f i m m 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 § 8 1 1
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.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
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.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?

In-depth Report

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
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.§2,3,5,15,16
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.7
FoundationOne®CDx Single biomarker testing

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


  1. Frampton GM, et al. Nat Biotechnol. 2013;31:1023–1031.
  2. Drilon A, et al. Clin Cancer Res. 2015;21:3631–9
  3. Rankin A, et al. Oncologist. 2016;21:1306–1314.
  4. Ross JS, et al. Cancer. 2016;122:2654–62.
  5. Suh JH, et al. Oncologist. 2016;21:684–91.
  6. Hirshfield KM, et al. Oncologist. 2016;21:1315–25.
  7. FoundationOne® CDx Technical Specifications M-GB-00001548 September 2020.
  8. Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–68.
  9. Schwaederle M, et al. Mol Cancer Ther. 2016;15:743–52.
  10. Wheler JJ, et al. Cancer Res. 2016;76:3690–701.
  11. Dhir M, et al. Cancer Med. 2017;6:195–206.
  12. Chalmers ZR, et al. Genome Med. 2017;9:34.
  13. Dudley JC, et al. Clin Cancer Res. 2016;22:813–20.
  14. Masucci GV, et al. J Immunother Cancer. 2016;4:76.
  15. Ali SM, et al. Oncologist. 2016;6:762–70.
  16. Schrock AB, et al. Clin Cancer Res. 2016;22:3281–5.
  17. FoundationOne® CDx Gene List. M-GB-00001549 September 2020. Download here
  18. NCCN Clinical Practice Guidelines in Oncology. Non-small cell lung cancer. Version 3.2019. January 2019. Available at: https://www.nccn.org/professionals/physician_gls/. Last accessed November 2019.
  19. https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Last accessed September 2020