The Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx (Foundation Medicine), a pan-tumor liquid biopsy test for use as a companion diagnostic to help inform cancer treatment decisions.

Specifically, the test is approved to detect BRCA1, BRCA2 alterations in patients with metastatic castration-resistant prostate cancer who are being evaluated for treatment with rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor.  It can also be used to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations that may benefit from treatment with 3 tyrosine kinase inhibitors: erlotinib, gefitinib, osimertinib.

Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations. “For many patients, getting a tissue biopsy is not an option due to tumor location or the patient’s health status, or a patient may simply prefer not to have an additional procedure,” said Andrea Ferris, President and Chief Executive Officer of LUNGevity Foundation. “Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer.” Clinicians are then provided with a comprehensive report that helps guide treatment for their patients.

Additionally, the FoundationOne Liquid CDx test provides information on genomic signatures such as blood tumor mutational burden and high microsatellite instability, as well as single gene alterations, including all NTRK fusions, for all solid tumor cancers.


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The test will be commercially available on August 28, 2020.

For more information visit foundationmedicine.com.

Reference

FDA approves Foundation Medicine’s FoundationOne®Liquid CDx, a comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer. https://www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721. Accessed August 27, 2020.

This article originally appeared on MPR