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FDA-approved companion diagnostic

FoundationOne Liquid CDx

FDA-approved liquid biopsy CGP assay analyzing ctDNA from blood to detect genomic alterations in solid tumors and guide use of targeted therapies.

Lab-developed CDxMethod: NGSSpecimen: Whole bloodBiomarker: 324 genes
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P190032
Supplements
S001, S004, S005, S008, S010, S011, S014, S015, S016, S023
Manufacturer
Foundation Medicine, Inc.
Approval date
August 26, 2020
Test specifications
Methodology
NGS
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
10 Days
Biomarker(s)
What this test is

FoundationOne Liquid CDx is an FDA-approved, cfDNA-based next-generation sequencing assay that profiles over 300 cancer-related genes from a simple blood draw. By detecting key genomic alterations in solid tumors, it supports therapy selection as a companion diagnostic and can inform eligibility for multiple targeted treatments.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerPIK3CAalterations (including mutations)ITOVEBI + IBRANCE + FASLODEX
C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047YPIQRAY
Metastatic Castrate Resistant Prostate Cancer (mCRPC)BRCA1 and BRCA2alterations (including mutations)AKEEGA, LYNPARZA + ZYTIGA, RUBRACA
BRCA1, BRCA2 and ATMalterations (including mutations)LYNPARZA
Metastatic Colorectal Cancer (mCRC)BRAFV600EBRAFTOVI + ERBITUX
Non-Small Cell Lung Cancer (NSCLC)ALKgene rearrangementsALECENSA
BRAFV600EBRAFTOVI + MEKTOVI
EGFR (HER1)Exon 19 deletion or exon 21 L858R substitution mutationIRESSA, LAZCLUZE + RYBREVANT, TAGRISSO, TARCEVA
Exon 20 insertionsEXKIVITY
METsingle nucleotide variants and indels that lead to MET exon 14 skippingTABRECTA, TEPMETKO
ROS1fusionsROZLYTREK
Solid TumorsNTRK1, NTRK2 and NTRK3fusionsROZLYTREK

Performing lab

Foundation Medicine, Inc.

Boston Lab (22D2027531)

At Foundation Medicine, our mission is to transform lives in cancer and beyond. We strive to provide multi-modal precision diagnostic solutions to transform cancer care throughout a patient’s experience, from pre-diagnosis to ongoing management and monitoring. Leveraging our vast knowledge of precision medicine, we partner with biopharmaceutical companies to accelerate the development of new personalized therapies in cancer and in a range of other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedInXYouTubeFacebook and Instagram.

Order this test

If your organization is connected to Casandra, you can place an electronic order forFoundationOne Liquid CDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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