For the complete label, including companion diagnostic indications and complete risk information, please visit. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. A negative result does not rule out the presence of an alteration. Use of the test does not guarantee a patient will be matched to a treatment. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product.
The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. # Foundation Medicine detects both somatic and germline alterations but does not differentiate between the two on reports.įoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. ¶ FoundationOne Liquid CDx only reports MSI when determined to be high The test is designed to provide physicians with clinically actionable information both to consider appropriate therapies for patients and understand results with. | FoundationOne Liquid CDx reports on bTMB FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors. § For the most current information about the therapeutic products in this group, go to.
Erbitux® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. Alecensa® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha. Vectibix® is a registered trademark of Immunex Corporation. Rubraca® is a registered trademark of Clovis Oncology, Inc. Piqray® is a registered trademark of Novartis AG. Tabrecta TM is a trademark of Novartis AG. Pemazyre TM is a trademark of Incyte Holdings Corporation. Keytruda® is a registered trademark of Merck Sharp & Dohme Corp. ‡ Tarceva® is the registered trademark of OSI Pharmaceuticals, LLC. Zelboraf®, Herceptin®, Perjeta®, Kadcyla®, and Cotellic® are registered trademarks of Genentech, Inc. Gilotrif® is a registered trademark of Boehringer Ingelheim International GmbH. Iressa® and Tagrisso® are registered trademarks of the AstraZeneca AB Corporation. Xalkori® is a registered trademark of Pfizer Inc. Zykadia®, Tafinlar®, and Mekinist® are registered trademarks of Novartis AG Corporation Switzerland. †Medicare and Medicare Advantage members have coverage of FoundationOne CDx in accordance with the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) criteria. * PD-L1 by Immunohistochemistry (IHC) can be ordered as a supplemental test and may inform eligibility for several immunotherapies across different cancer types