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FoundationOne®Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek® (entrectinib)

Foundation Medicine’s liquid biopsy test can now be used by oncologists to identify more patients with rare mutations within their cancer for whom treatment with Rozlytrek may be appropriate

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group. FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib). This decision from the FDA follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, FoundationOne®CDx, for the same therapy last year.

CGP has transformed the traditional ‘one-size fits-all’ approach to cancer and is an important tool for identifying rare and hard to find mutations, including ROS1 and NTRK. NSCLC is the most common type of lung cancer, accounting for 80-85 percent of all lung cancer diagnoses.1ROS1 gene fusions are seen in 1-2 percent of these NSCLC diagnoses.2NTRK gene fusions are also rare, occurring in roughly 0.3 percent of all solid tumors,3 however these can be found in many tumor types including breast, cholangiocarcinoma,colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.4

“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,” says Dr. Mia Levy, chief medical officer at Foundation Medicine. “Liquid biopsies can make molecular testing possible for patients when tissue is not available and we’re excited that just over six months after the approval of our tissue-based test as a companion diagnostic for Rozlytrek, our blood-based test can now also be offered to support doctors in connecting their patients with this targeted treatment option.”

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations that cause the cancer to grow, and it is now approved as a companion diagnostic for nine targeted therapies. Foundation Medicine’s two FDA-approved tests both meet rigorous analytical and clinical validation standards and demonstrate Foundation Medicine’s deep regulatory expertise – FoundationOne Liquid CDx has the broadest gene panel of any FDA-approved blood-based test, and the company’s tissue-based CGP test, FoundationOne CDx, was the first ever FDA-approved broad companion diagnostic test.

About FoundationOne®Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is 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 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. For the complete label, including companion diagnostic indications and complete risk information, please visit

About FoundationOne®CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. 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. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on and follow us on Twitter and LinkedIn.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

1 American Cancer Society. What Is Non-Small Cell Lung Cancer? Available from:

2 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer. Available from:

3 Westphalen, C.B., Krebs, M.G., Le Tourneau, C. et al. Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population. npj Precis. Onc. 5, 69 (2021).

4 Demetri GD et al. Efficacy and Safety of Entrectinib in Patients with NTRK Fusion-Positive (NTRK-fp) Tumors: Pooled Analysis of STARTRK-2, STARTRK-1 and ALKA-372-001. Presented at ESMO 2018; October 19-23, 2018; Munich, Germany. Abstract LBA17

Foundation Medicine:
Abigail Alderman, 781-534-3210

Source: Foundation Medicine

January 5, 2023