FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Olaparib

The FDA has approved the FoundationOne Liquid CDx to be used as a companion diagnostic for olaparib (Lynparza), according to Foundation Medicine, the developer of the companion diagnostic.

The FoundationOne Liquid CDx uses a blood-based biopsy to identify patients with BRCA1, BRCA2, and/or ATM alterations in patients with metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with olaparib. The comprehensive genomic profiling test is now approved as a companion diagnostic for 7 targeted therapies across 4 tumor types.

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, said in a press release. “The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions.”

The 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. Additional genomic findings may be reported by the test however 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. A negative result does not rule out the presence of an alteration, and 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.

The FoundationOne Liquid CDx was approved by the FDA in August to report genomic alteration results for patients with any solid tumor. Notably, Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne CDx, was also approved as a companion diagnostic for olaparib in May 2020.

Reference:

Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be used as a Companion Diagnostic for LYNPARZA® [news release]. Cambridge, Massachusetts. Published November 9, 2020. Accessed November 9, 2020. https://www.foundationmedicine.com/press-releases/3ace3473-1335-43bd-9454-2388c5549bf8