FoundationOne Liquid CDx Receives Expanded FDA Indication in Metastatic Castration-Resistant Prostate Cancer


The FDA expanded approval of FoundationOne® Liquid CDx as a companion diagnostic for olaparib, which is currently indicated for use as treatment in patients with BRCA1/2 and/or ATM alterations in metastatic castration-resistant prostate cancer.

The FDA has expanded approval of FoundationOne® Liquid CDx as a companion diagnostic for PARP inhibitor olaparib (Lynparza), which is currently indicated for use as treatment in patients with BRCA1/2 and/or ATMalterations in metastatic castration-resistant prostate cancer (mCRPC), announced Foundation Medicine, Inc, in a press release.1

FoundationOne CDx was previously granted approval in August for the indication of patients with any solid tumor. This update follows news from October 28, 2020, as well, which showed FDA approval of this assay as a companion diagnostic to identify patients who may receive benefit of 3 additional FDA-approved treatments across various solid tumors.2

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care,” said Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, in a statement. “The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions.”

Olaparib received approval in May 2020 for the treatment of patients with mCRPC who have deleterious or somatic homologous recombination repair (HRR) gene mutations and have progressed on prior therapy with a new hormonal agent.3 This was approved based on findings from the PROfound study, which was supported by Foundation Medicine and was the first positive phase 3 biomarker-selected clinical trial that used a molecularly targeted treatment in mCRPC, and it was also the largest prospective phase 3 study that performed central tissue testing for HRR gene mutations in patients with mCRPC.1

FoundationOne Liquid CDx report is able to provide information regarding genomic signatures microsatellite instability and blood tumor mutations burden, as well as single gene alterations like NTRK fusions, which can help inform treatment decisions. It is also able to deliver clinical trial information and includes interpretive content developed in accordance with guidelines regarding treatment of patients in oncology with any solid tumor.

The companion diagnostic is indicated to identify BRCA1/2 genes, as well as ATM genes, in patients with mCRPC who are eligible for treatment with the PARP inhibitor.3

The FoundationOne Liquid CDx assay is also indicated for the detection of BRCA1/2 genes in patients with ovarian cancer who are eligible for rucaparib (Rubraca), of ALK rearrangements in patients with non – small cell lung cancer (NSCLC) who are eligible for treatment with alectinib (Alecensa), and of PIK3CA genes in patients with breast cancer who are eligible to receive alpelisib (Piqray).

FoundationOne Liquid CDx received its approval for the multiple indications based on retrospective findings from testing with the liquid biopsy assay; available plasma samples were tested from patients enrolled to 4 studies supporting use of the associated treatments. The efficacy of these agents were maintained in patients with confirmed BRCA1/2 gene alterations for rucaparib, PIK3CA mutations for alpelisib, ALK rearrangements for alectinib, and BRCA1, BRCA2, and/or ATM gene alterations for olaparib.

According to an update from the FDA, if specific mutations/alterations associated with these approved indications are not identified in the blood, a tumor biopsy is recommended to determine if the mutations and alterations may be present.

FoundationOne Liquid CDx is a comprehensive liquid biopsy assay that assesses tumors according to testing guidelines across cancer types, which has been able to evaluate more than 300 cancer-related genes and alterations. Findings are indicated in a report that demonstrates alterations in patients and the matched FDA-approved treatment that target the appropriate alteration.


1. Foundation Medicine Expands Indication for FoundationOne® Liquid CDx to be used as a Companion Diagnostic for Lynparza. News Release. Foundation Medicine, Inc. November 9, 2020. Accessed November 9, 2020.

2. FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers. FDA. November 9, 2020. Accessed November 9, 2020.

3. FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer. FDA. Posted May 20, 2020. Accessed November 9, 2020.

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