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

Summary

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
Validation

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