On January 4, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported 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 (Press release, Foundation Medicine, JAN 4, 2023, View Source [SID1234625846]). 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, FoundationOneCDx, for the same therapy last year.

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"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"

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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.1 ROS1 gene fusions are seen in 1-2 percent of these NSCLC diagnoses.2 NTRK 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.