Join Foundation Medicine at the 2024 AUA Annual Meeting, Booth #110
Meet with our team at AUA
FoundationOne®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. 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. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients being considered for eligibility for therapy based on detection of NTRK1/2/3 and ROS1 fusions should only be tested if tissue is unavailable. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
*Based on somatic testing guidelines in advanced prostate cancer, including 19 HRR genes, MSI/MSI-H, plus 7 clinically relevant biomarkers (TMB, MSH2, MSH6, PMS2, PTEN, RB1, TP53).
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V4.2023. © 2023 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed February 12, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org.
FoundationOne Liquid CDx Technical Specifications (Gene List). https://www.foundationmedicine.com/sites/default/files/media/documents/2023-10/F1LCDx_Technical_Specs_072021-2.pdf. Accessed February 13, 2024.
FoundationOne CDx Technical Specifications (Gene List). https://www.foundationmedicine.com/sites/default/files/media/documents/2024-01/F1CDx%20Technical%20Specifications%20SPEC-01197.pdf. Accessed February 13, 2024.
Orme JJ, Taza F, De Sarkar N, et al. Co-occurring BRCA2/SPOP Mutations Predict
Exceptional Poly (ADP-ribose) Polymerase Inhibitor Sensitivity in Metastatic Castration-Resistant Prostate Cancer. Eur Urol Oncol. Published online December 9, 2023. doi:10.1016/ j.euo.2023.11.014.Swami U, Graf RP, Nussenzveig RH, et al. SPOP Mutations as a Predictive Biomarker for Androgen Receptor Axis-Targeted Therapy in De Novo Metastatic Castration-
Sensitive Prostate Cancer. Clin Cancer Res. 2022;28(22):4917-4925. doi:10.1158/1078-0432.CCR-22-2228.