FDA Approves FoundationOne Liquid CDx to Identify Genomic Profile in NSCLC


The biopsy test is the first companion diagnostic approved for entrectinib for individuals who do not have an available tissue sample.

The FDA has approved FoundationOne Liquid CDx (Foundation Medicine) to be used as a companion diagnostic to identify individuals with ROS1-positive non–small cell lung cancer (NSCLC) or those with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be eligible for treatment with entrectinib (Rozlytrek; Genentech).1

FoundationOne Liquid CDx is the only blood-based companion diagnostic approved for entrectinib. This decision follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test for the same therapy last year.1

“With the most FDA-approved companion diagnostic claims of any blood-based comprehensive genomic profiling test, FoundationOne Liquid CDx is an accessible tool for evidence-based, guideline-adherent therapy selection,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a statement.1 “Liquid biopsies can make molecular testing possible for patients when tissue is not available and we’re excited that just over 6 months after the approval of our tissue-based test as a companion diagnostic for [entrectinib,] our blood-based test can now also be offered to support doctors in connecting their patients with this targeted treatment option.”.1

CGP is an important tool to determine harder-to-find mutations, such as ROS1, seen in approximately 1% to 2% for SCLC diagnoses, and NTRK, seen in approximately 0.3% of all solid tumors, according to the statement.

The tumor types can include breast, cholangiocarcinoma, colorectal, gynecological, NCSLC, neuroendocrine, pancreatic, salivary gland, sarcoma, and thyroid.1

Using a blood sample, FoundationOne Liquid CDx can analyze more than 300 genes that genomic alterations that results in cancer growth. It is now approved as a companion diagnostic for 9 targeted therapies.1

Both FDA-approved tests meet rigorous analytical and clinical validation standards.

In 2022, the FDA approved FoundationOne CDx for the same indication. The FoundationOne CDx is a CGP pan-tumor tissue biopsy test that assesses an individual’s cancer and identifies the unique molecular “fingerprint” of the tumor.2

make informed and personalized treatment decisions, hopefully achieving better clinical outcomes.2


1. FoundationOne Liquid CDx receives FDA approval as a companion diagnostic for Rozlytrek (entrectinib). Business Wire. News release. January 4, 2022. Accessed January 6, 2023. https://www.businesswire.com/news/home/20230104005548/en

2. Gallagher, A. FDA approves FoundationOne CDx for use with entrectinib For NSCLC, solid tumors. June 23, 2022. Accessed January 6, 2023. https://www.pharmacytimes.com/view/fda-approves-foundationone-cdx-for-use-with-entrectinib-for-nsclc-solid-tumors

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