Foundation Medicine

FoundationOne®CDx

FoundationOne®CDx is a Personalized Cancer Treatment Map for all solid tumors.

FoundationOne CDx is the first FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors FoundationOne®CDx scans the entire coding sequence of 324 cancer-related genes and has the ability to detect genomic changes necessary to extensively map a solid tumor.^6,7

This DNA test is designed to provide physicians with clinically feasible information based on the personal genomic profile of each cancer patient -both for the evaluation of appropriate cancer treatment for patients and for the results to be understood with the findings regarding the resistance to treatment. Thus, it can also help to understand the changes causing cancer disease and to identify unpredictable targeted cancer treatment options before DNA testing.^1,2,3,4

FoundationOne®CDx ensures the reproduction of gene fragments with the Hybrid Capture method, ensuring that all fragments are adequately covered and maximizing the probability of catching the existing genomic change.^1,2 Each DNA test result also contains information to help guide immunotherapy decisions regarding microsatellite instability (MSI) and tumor mutation burden (TMB). ³

TMB and MSI

Tumor Mutation Load (TMB) and Microsatellite Instability (MSI) are included in each FoundationOne® and FoundationOne®Heme report to guide our physicians without additional tissue, cost or time. These markers, which are used in some tumor types, can guide our physicians about whether patients can benefit from immunotherapies.

To download the TMB brochure. Click here.
To see frequently asked questions about TMB. Click here.

It scans the entire coding sequence of 324 genes and 28 gene introns.

It detects all 4 types of genomic changes.

It works even with small amounts of low purity tissue samples.

It provides a clear and comprehensive report

* For detailed information, visitinfogenetik.com website.
https://www.foundationmedicine.com

References

FoundationOne®CDx clinical validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx (Accessed August 2018);
FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech;
Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
FoundationOne®CDx Sample Report, 2018. Available at: www.rochefoundationmedicine.com/reporting;
Stratton MR et al. The Cancer Genome. Nature 2009;458 (7239):719-24
FoundationOne®CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2018);
FoundationOne®CDx FDA Approval Press Release, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587273.htm (Accessed August 2018);
Kris MG et al (2014) JAMA 311(19):1998-2006
Barlesi F et al (2016) Lancet S0140-6736 (16)
Schwaederle M et al (2015) J ClinOncol (33) 2015

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