FDA Approves FoundationOne Liquid CDx for 3 New Companion Diagnostic Indications

The FDA approved the FoundationOne Liquid CDx for 3 new companion diagnostic indications to help match patients who could benefit from treatment with specific FDA-approved targeted therapies.

The FDA has approved the FoundationOne Liquid CDx for 3 new companion diagnostic indications to help match patients who could benefit from treatment with specific FDA-approved targeted therapies, according to Foundation Medicine, the developer of the test.

The new indications are for alpelisib (Piqray) in advanced or metastatic breast cancer, rucaparib (Rubraca) in advanced ovarian cancer, and alectinib (Alecensa) in a certain type of metastatic non-small cell lung cancer (NSCLC). In addition, the agency also approved a label expansion which now allows the FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements.

“FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, said in a press release. “These three additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach.”

More specifically, the FoundationOne CDx is now approved to include the aforementioned targeted therapies for the following indications:

  • Alpelisib in combination with fulvestrant (Faslodex) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
  • Rucaparib for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 2 or more chemotherapies. Patients are selected for therapy based on an FDA-approved companion diagnostic for the agent.
  • Alectinib for the treatment of patients with ALK-positive metastatic NSCLC, as detected by an FDA-approved test.

The FoundationOne Liquid CDx is a qualitative next generation sequencing diagnostic test based in vitro 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 the anti-coagulated peripheral whole blood of patients with advanced cancer. Currently, the test is approved by the FDA to report short variants in these genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling.

However, additional genomic findings may be reported by the test and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Moreover, use of the test does not guarantee a patient will be matched to a treatment, and a negative result does not rule out the presence of an alteration. Foundation Medicine indicated that patients who are negative for companion diagnostic mutations should instead be referred to tumor tissue testing and have mutation status confirmed using an FDA-approved tumor tissue test, if feasible.


FDA Approves New FoundationOne®Liquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and Non-Small Cell Lung Cancer [news release]. Cambridge, Massachusetts. Published October 27, 2020. Accessed October 27, 2020. https://www.foundationmedicine.com/press-releases/d7f17f4f-ab71-4c2b-9b98-bb12df081de1

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